Career Opportunities at Aspen Pharma Group

Description

Overview 

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures and document controls
• Manage Production Pharmacists and PMA’s
• Deliver expected value stream targets as per business requirements
• Facility GMP compliance
• Team and process development

Requirements

Requirements

Background/experience

• BPharm Degree
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Leadership
• Managing complex task and integration of multiple variables
• Interrogating information
• Meeting deadlines
• Finalising output
• Taking action

Accountability & Decision Rights

• Work on assignments of moderate - large size, scope, diversity and/ or complexity
• Able to work without supervision and achieve target objectives
• Seek guidance when needed; escalate only when required

Independent decisions relating to:

• Team work methods, occasionally in ambiguous situations, guided by precedent, previous experience, business priorities and known professional guidelines/ compliance requirements
• Interpretation of policies, standards, requirements and approaches
• Setting of work priorities for self and team

Responsibilities

Staff development

• Train new Pharmacists and PMAs on SOPs in transition period
• Ensure pharmaceutical and supervisory team training is compliant
• Oversee staff professional development to ensure team value add is realized
• Facilitate training sessions as required
• Mentorship and guidance to pharmaceutical teams

Product release management

• Facilitate end to end product release process withing production department
• Deviation management and adherence to daily, weekly targets
• Raise deviations, complete forms and investigations as required and implement corrective action
• Facilitate incident review process
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution
• Ensure deviation owner allocation and re-allocation in accordance to priorities
• Ensure CAPA actions are implemented (deviations, CAPAs, Change controls)

Process and system improvements

• Continuously review process impacting manufacturing and release to identify and implement optimization measures to improve efficiency and effectiveness
• Manage, review and approve change control programs and deviations/
• concessions comply to standards and specifications
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus
• Implement and maintain KPIs and trackers supporting business objectives

Planning

• Plan and prioritise own and team daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally
• Align activities with business and customer product release priorities

Stakeholder management

• Key interface between production and support departments with main interface being with the QA department
• Customer interface as needed to share information, feedback on open items, retrieve guidance and facilitate priorities

GMP Compliance

• Facilitate and support audit management
• Enforce and control area compliance (personnel, documentation, process, product)
• Ensure production process adherence to standards and specifications
• Enable teams and process to achieve documentation and deviation right first time targets

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Applications must apply on Direct Hire: https://aspen.mcidirecthire.com/Internal/CurrentOpportunities

Closing Date: 14 November 2022

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Description

• Provision of business support on all aspects of the area’s work
• Coordination and execution of administrative functions within the Capability area

   Administrative Support

• Provide input into work activities and priorities for the capability department
• Assist in organizing and scheduling meetings
• Coordinate and manage training center calendar bookings
• Coordinate office services
• Perform administrative, customer-support and computational tasks
• Attend scheduled meetings
• Order/ buy stationery and consumables as and when required
• Perform any other administrative tasks related to work area as and when required
• Provide support in audits and pre-audits
• Coordinate canteen orders for meals when required

Reporting and record-keeping

• Assist in the gathering information required for reporting
• Assist in compiling standardised reports and consolidate documents
• Maintain and update records on LMS as required
• Assist in retrieving supporting documentation and records to facilitate and support query resolution
• Maintaining and organizing filling system – ensuring that records are always up to date for audit purposes

Requirements

To be eligible for this opportunity:

• All applicants must have completed Grade12
• Applicants must have NC: Business Administration L2
• The programme is intended for people living with disabilities

An energetic, self-starter who will be able to deal with multifaceted situations, committed to excellence and has a keen willingness to learn.

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Closing Date: 11 November 2022

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Description

This one-year internship programme at our East London manufacturing site will provide candidates with an opportunity to complete the required practical learning component of their qualifications, and gain workplace experience, knowledge and skills related Microbiology laboratory in the pharmaceutical industry.

Requirements

• Bachelor of Science major in Microbiology
• National diploma in Microbiology
• Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
• Aspen reserves the right to not make an appointment.
• Incomplete applications will not be considered.
• Candidates may be required to undergo assessments.
• Aspen bursary holders may receive priority attention.

Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.

Aspen subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Closing Date: 11 November 2022

go to method of application »

Description

This one-year internship programme at our East London manufacturing site will provide candidates with an opportunity to complete the required practical learning component of their qualifications, and gain workplace experience, knowledge and skills related Chemical laboratory in the pharmaceutical industry.

Requirements

• Bachelor of Science major in Chemistry
• National diploma in Chemistry
• Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
• Aspen reserves the right to not make an appointment.
• Incomplete applications will not be considered.
• Candidates may be required to undergo assessments.
• Aspen bursary holders may receive priority attention.

Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.

Aspen subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Closing Date: 11 November 2022

Work Level

Student/Graduate

Job Type

Contract

Salary

Market Related

Duration

9 - 12 Months

EE Position

Yes

Location

East London

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Description

Are you looking for a career opportunity with an organisation whose values you can live by?

NTEGRITY, INNOVATION, TEAMWORK, COMMITMENT and EXCELLENCE.

Join South Africa’s global speciality and branded multinational pharmaceutical company with a presence in both emerging and developed markets and say it was you who joined Aspen.

Begin your 12-month graduate programme with Aspen and its extensive basket of products that provide treatment for a broad spectrum of acute and chronic conditions experienced through all stages of life. Our 12-month graduate programme is premeditated to develop young talent, striving for professional and personal growth.

You will attain working knowledge of Aspen as a business and you will learn how to deliver on high business demands, enduring pro-active and results-driven traits within a diverse workforce and high-performance culture, in sustaining profitable portfolios through brand management exposure, strategy development, innovation and flawless execution.

This opportunity is intended to provide you with a compact foundation to further develop and succeed in your career, throughout the graduate programme you will be offered guidance and mentorship, followed by quarterly evaluations.

Requirements

To be eligible for this opportunity:

• Applicants must have completed Grade12
• Applicants must have graduated with a Degree in Commerce; Science and/or Marketing
• Have energy graduate and passion for working with people.
• gAn energetic, self-starter who will be able to deal with multifaceted situations, committed to excellence and has a keen willingness to learn.

The job applicant acknowledges, agrees, accepts, and understands that the Company (Pharmacare Limited t/a Aspen Pharmacare),  has a mandatory Covid-19 Vaccination Policy and Plan which, inter alia, provides for mandatory vaccination for all employees at SA Commercial. Mandatory Covid-19 vaccination applies to this job vacancy. As such, in applying for and if applicable accepting an offer of employment for this job role,  the applicant warrants that s/he is fully vaccinated, and that his/her vaccination status is valid and up to date. The Job applicant’s electronic vaccination certificate, as issued by the NDOH, must be provided if the job application results in an offer and subsequent acceptance of this offer of employment. The applicant acknowledges, further, that there is no particular reason that he/she would refuse any future booster or vaccination requirements that may/should be recommended by the South African health authorities.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 10 November 2022. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application.

Work Level

Student/Graduate

Job Type

Contract

Salary

Market Related

Duration

EE Position

Yes

Location

Gauteng

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Description

Company Description

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

Objective:.

To support the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.

To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa.  To ensure growth and sustainability of Aspen Pharmacare’s SA product portfolio within the legislative framework of the country and in compliance with the company strategy.

The role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.

To perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies.

To meet the needs of healthcare providers and patients/consumers through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information, and promotional and non-promotional material, and to respond to unsolicited inquiries from regulatory authorities, including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection.

KEY RESPONSIBILITIES

FINANCIAL

• Effective utilisation of resources to keep processes cost effective.
• Adhering to Regulatory Affairs budget and forecasts.

MEDICAL INFORMATION (MI)

• Providing support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
• Providing compliant responses to internal and external customers.
• Creating and maintaining standard responses (SRs) and Objection Handlers (OHs).

Ensuring that the relevant department/s are informed in:

• a timely manner (at receipt or at least within 24 hours) 
• following the receipt of adverse events or product quality complaints/potential counterfeit medicines.   This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
• Ensuring that Affiliate/Distributor/MI is adhering with 
• Aspen’s Policy in providing scientific support to internal and external customers.
• Identifying gaps and suggesting ways of process improvement in MI.
• Ensuring that the reconciliation between Medical Information function and Pharmacovigilance and the Quality department is effective by performing ad hoc reviews on reconciliation files.
• Ensuring that any suggested improvements within the professional information and/or patient information leaflets are communicated to the PV Lead at the point of identification.
• Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
• Managing after hour MI enquiries on a rotational basis.
• Ensuring telephony system testing documents are completed as per allocation.
• Ensuring compliance to Key Performance Indicators (KPIs) response timelines. 
• Ensuring a professional attitude is displayed when responding to a customer’s needs.

 PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING

• Reviewing and approving promotional material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Reviewing and approving educational, scientific and other non-promotional material for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Liaising with marketing divisions regarding advice, queries, and timelines in relation to the above.
• Assisting with the review of information relevant to each product.
• Attending promotional campaign concept presentations at the request of the marketing teams to provide regulatory support and input.
• Ensuring that compliance monitoring is performed on all territories and non-compliances are escalated in a timely manner to the line manager as per Aspen group policies.
• Supporting the line manager in developing and maintaining procedural documents for compliance monitoring.
• Supporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
• Supporting the line manager in generating reports associated with compliance monitoring activities.

REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36):

• Performing clinical due diligence for new intellectual property as received from the regulatory function.
• Creating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
• Creating company core data sheets.
• On time responses to clinical evaluation recommendations (CERs) and clinical screening enquiries.
• Accurate compilation and filing of the electronic submission documentation.
• Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
• Maintaining tracking tools to ensure on time submission and reporting.
• Identifying process enhancements.
• Ensuring accurate uploading of the current approved PIs and PILs to the SA Regulatory Portal and submission to SAHPRA for uploading to the PI/PIL Repository (and relevant platforms).
• Managing Section 21 and 36 submissions. 

IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL:

• Ensuring that RMP material is created, maintained and rolled out to market.
• Ensuring that the relevant sales force team is adequately trained, and training records are filed.
• Ensuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA

PRINTED PACKAGING/ARTWORK

• Reviewing and approving concept of new or updated artwork/printed packaging material for medicines and related products for the SA and SADC markets in compliance with applicable legislation and corporate requirements.

AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION  (PI) AND PATIENT INFORMATION LEAFLETS (PILs)

• Assisting with the translation and/or validation of Afrikaans PIs (where required) and PILs for both new and existing products.
• Ensuring that translations are undertaken accurately and timeously.

PROJECT MANAGEMENT

• Providing assistance with any specific projects and operational support for the MI and Compliance team

MAINTENANCE OF THE ASPEN MEDICALLY CRITICAL LIST

• Initiating and finalising a bi-annual review of the Aspen  medically critical list.

 QUALITY MANAGEMENT SYSTEMS

• Maintaining procedural documents for the Medical Information and Compliance function as specified in the individual KPAs (as per identified     subject matter expert/s).
• Ensuring accurate and ‘real-time’ filing of training records.
• Ensuring ‘real-time’ maintenance of TrackWise/QAlign records.
• Ensuring that relevant documentation requested by 
• auditors is provided in a timely manner during internal and external audits.
• Ensuring that training records are up to date to ensure audit readiness.
• Ensuring that the commercial team members are trained on those RA:SQC procedures where there are shared responsibilities.

GENERAL

• Ensuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• Adherence to agreed Key Performance Indicators (KPIs).
• Supporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.
• Ensuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure/instructions.
• Adherence to Company Health & Safety procedures.
• Participation in training programmes.
• To provide a leadership role as required by taking responsibility for specified areas and coaching of staff.
• Any other duties as assigned by Manager.

Requirements

Knowledge:

• Regulatory Authority requirements/legislation
• Understanding of the laws and requirements governing the marketing of medicines and printed packaging Guidelines and codes of practice
• Understanding requirements of medical information and information management
• Terminology – understanding the jargon
• Understanding business processes
• Product knowledge
• Industry knowledge
• Dossiers and requirements

Skills and Attributes:

• Integrity, good work ethic and ability to meet deadlines
• Self-starter
• Analytical and planning skills
• Accuracy and attention to detail
• Effective organisational skills and ability to prioritise
• Ability to work under pressure and to tight deadlines
• Ability to work in a fast-paced international environment
• Ability to manage projects in a matrices team environment and  with both internal and external partners
• Willing to travel if required
• Presentation skills
• Time management skills
• Service orientation
• Decision making skills
• Customer focused
• Self-confidence
• Organisational awareness
• Information seeking
• Excellent interpersonal and communications skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback  and updates
• Enthusiasm and drive to take ownership and drive process  initiatives
• Logical thinking
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility and confidentiality
• Empathy, patience, influence
• Sense of urgency
• Positive and pro-active approach to business tasks
• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)

EDUCATION & EXPERIENCE

• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
• Multilingualism (including Afrikaans) would be an advantage
• Minimum 1 to 2 years’ pharmaceutical experience
• Experience in Medical Information is an advantage
• Effective use of appropriate IT systems and programs
• Ability to work with multi geographical locations & time zones
• Experience in medicine legislation and related guidelines and codes of practice preferable

The job applicant acknowledges, agrees, accepts, and understands that the Company (Pharmacare Limited t/a Aspen Pharmacare), has a mandatory Covid-19 Vaccination Policy and Plan which, inter alia, provides for mandatory vaccination for all employees at SA Commercial. Mandatory Covid-19 vaccination applies to this job vacancy. As such, in applying for and if applicable accepting an offer of employment for this job role, the applicant warrants that s/he is fully vaccinated, and that his/her vaccination status is valid and up to date. The Job applicant’s electronic vaccination certificate, as issued by the NDOH, must be provided if the job application results in an offer and subsequent acceptance of this offer of employment. The applicant acknowledges, further, that there is no particular reason that he/she would refuse any future booster or vaccination requirements that may/should be recommended by the South African health authorities.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 13 October 2022. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Work Level

Skilled

Job Type

Permanent

Salary

Market Related

EE Position

Yes

Location

Gauteng