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Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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Job Overview:
- Monitor product quality throughout the manufacturing and packaging process
- Monitor QMS compliance with GMP standards
- Assist with deviations and quality investigations
- Provide input into SOPs to ensure compliance
- Related administrative tasks
Responsibilities
Planning and Process
- Plan and coordinate administrative activities
- Provide recommendations on process improvements
In-Process Quality Management
- Verify production plans for operation effectiveness
- Perform line opening visual inspections as per checklist
- Perform end-of-batch internal inspections to assess compliance and effectiveness of overall QMS
- Perform on-line inspections of batch documents during manufacturing and packaging process to assess compliance
- Perform inspections to monitor GMP compliance during manufacturing
- Perform inspection of logbooks, SOP files and AQL
- Perform final inspection of finished goods
- Raise deviations for non-conformances identified
- Record and report quality problems as they are identified
- Compile and issue report on non-conformances and ensure adequate CAPA plans have been implemented
- Assist with product and quality investigations
- Review and provide input into SOPs to ensure compliance to GMP standards and product specifications
- Establish and apply continuous improvement processes
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Participate in audits when required
- Participate in unit risk assessments
Reporting
- Coordinate and consolidate the gathering of information for reporting
- Compile detailed reports and documents
- Monitor and control data integrity in all databases
Communication
- Communicate with employees and management, to assist and convey information
Requirements
Skills Required
Background/experience
- Grade 12 with 6+ years’ related experience, or 2-year Diploma with 4+ years’ related experience
- Pharmaceutical manufacturing experience
Specific job skills
- Strong working knowledge of pharmaceutical quality operations and quality management systems
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Information Gathering
- Following Procedures
- Capturing Facts
- Taking Action
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Description
- Fine Chemicals requires the services of a highly competent and experienced QA Inspector for the Quality Assurance Department. To qualify for this position the most suitable candidate must fulfill the following requirements.
Requirements
JOB REQUIREMENTS:
- A tertiary qualification - National Diploma/BTech in Quality or BSc Chemistry or Life Sciences
- GMP experience – knowledge of ICH and FDA guidelines for API manufacturers and their application, and relevant Quality system certification
- Must be computer literate, MS Windows, i.e., Word, Excel, PowerPoint, etc.
- Validation, Regulatory, and Production experience will be advantageous
BASIC JOB FUNCTIONS (Brief Summary):
- Carrying out site audits
- Document/report writing, reviewing, issuing, and change control
- Preparing the site for external audits and Regulatory Inspections
- Verification of validation activities within the nominated manufacturing area
- Producing and checking labels for raw materials, intermediates, and finished goods according to the set standard operating procedures and master schedule of standard labels
- Checking the issuing of tamper-evident packaging components according to the set procedure
- Ensuring production complies with cGMP, the BPR instructions, and all related SOPs
- Reviewing BPRs and raising deviations where necessary
- Assisting with the batch release procedure
- Maintaining the electronic databases related to the batches released
- Maintaining relevant filing systems that ensure traceability of the position’s functions
- Investigating and documenting deviations
- Participating in root cause analysis and CAPA identification
- Understanding and complying with all relevant SOPs
- Facilitate training in compliance with cGMP
- Performing internal audits
- Collate data as required to support the successful execution of validation studies
- Consult with Procurement and QC on Raw Material related matters to ensure BOM requirements are met, and Compliance issues attained (approval of suppliers)
- Provide ad hoc support to NPD Tech Transfer projects, legacy product re-location and validation
- Participate and review Risk Assessments as required
- Perform QA review of Regulatory statements/declarations
PERSONAL ATTRIBUTES (Brief Summary):
- Observation – ability to observe and evaluate processes and proceduresExcellent organisational and administrative skills
- Excellent problem-solving skills
- Attention to detail – proofreading and auditing
- Ability to communicate with all levels of the business
- Ability to interpret regulations and take initiative
- Confident to address adverse issues at all levels of the business
- Good interpersonal skills
- Ability to apply critical thinking to arising situations/scenarios
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Description
- Monitor manufacturing compliance to GMP and statutory requirements.
- Monitor adherence to guidelines, procedures, and document controls.
- Deliver expected productivity targets as per business requirements.
- Related administrative tasks.
- Serve as back up to Team Leader on shift.
Requirements
Planning and Procedures
- Plan and prioritize daily, weekly, and monthly activities
- Determine, request, and use resources/ assets optimally
Inspections and Verifications
- Verify schedule 5 products
- Verify certified clean status of rooms and equipment
- Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials
Line & Production processing
- Perform, review, and approve line sign-on’s, closures and clearance authorizations
- Perform, review, and approve batch reconciliations to product specifications and quality
- Ensure production process adherence to standards and specifications
Process and system improvements
- Manage, review, and approve change control programs and deviations/ concessions comply to standards and specifications
- Manage and resolve customer complaints
- Optimize processes and identify gaps in policies/ procedures
- Drive CAPA investigations in area of focus
Compliance & Auditing
- Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Review and approve preliminary batch records
- Audit logbooks and systems
Troubleshooting
- Investigate deviations and concessions, and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
Training and technical expertise
- Train new Pharmacists and PMAs on SOPs in transition period
- Identify refresher or awareness training needs
Administration & Record keeping
- Complete batch records and labels
- Complete deviation forms as required
- Query documents and sign off declarations
- Perform and verify calculations in BMR
- Maintain and update records and systems as required
- Retrieve supporting documentation and records to facilitate and support query resolution
Skills required
Background/experience
- Minimum of bachelor’s degree preferred, ideally in Pharmacy
- 1-3 years’ related work experience
- Pharmaceutical manufacturing experience
- Registration with Pharmacy Council
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
- Ability to interpret and implement policies, processes, and objectives
Competencies
- Information gathering
- Interrogating information
- Meeting deadlines
- Finalizing output
- Taking action
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OBJECTIVE:
To ensure that efficient and cost-effective business solutions and processes are in place to address business needs/requirements. This role will work closely with the other teams, assist in designing, developing, testing and maintaining software solutions.
KEY RESPONSIBILITIES:
Management of IT Service Delivery and Support
- Create, analyse, and validate detailed functional specifications
- Design, Build and implement relevant software solutions / Applications
- Facilitate design sessions with implementation teams to define solutions
- Testing of Solutions / Applications
- Share knowledge with other Teams
Stakeholder / Customer delivery
- Collaboration with clients / stakeholders to gather and understand business requirements
- Provide Application support and training for clients
- Train clients /stakeholders on new and existing Applications
- Build Stakeholder relationship
Innovation
- Identify current and future state business processes
- Drive business enabled innovation using technology
- Assess and refine existing processes, and develop new where necessary, to support the strategic direction of the organization
IT Governance
- Formulate technical requirements specification based on business requirements
- Assess and remediate any security vulnerability that may exist in technology
Requirements
QUALIFICATION AND EXPERIENCE:
Qualifications
- Matric / Grade 12
- Diploma / Degree in Information Technology field or equivalent work experience (+2 years) in an Information Technology environment
- Experience in Service management environment / Supporting the user Community and key stakeholders with proven experience of service support in a matrix approach with internal and external resources which may not be direct reports
Experience
- Experience in the developing solutions using Microsoft Power Platform MS PowerApps, Flow, Power Automate, Microsoft Forms
Knowledge Power BI
- Knowledge of Sharepoint Administration, ServiceNow
- Microsoft Office 365 knowledge is essential
- Ability to design database models
- Ability to facilitate interactive design and technical specification sessions
- Ability to work with all levels of the organization, both technical and non-technical
- Sound knowledge of methodologies & frameworks such as Agile, SDLC, Waterfall
- Knowledge of ERP system – SAP
Competencies
- Excellent analytical and technical skills
- Communicate effectively
- Facilitation
- Integrity & Honesty
- Customer Focused
- Persistence, Patience
- Innovative
- Results oriented
- Effective Problem solving and troubleshooting
- Accuracy & attention to detail.
- Self-development orientation.
- Dedication.
- Self Confidence.
- Assertiveness.
- Logical & Lateral thinking.
- Information Seeking.
- Persuasive, negotiation
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Description
- Monitor and report on manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures, and document controls
- Related support and administrative tasks
Inspections and Verifications
- Perform visual inspections of rooms, machine parts and equipment
- Verify that rooms and equipment are certified clean as per SOP
- Verify scale and measuring equipment performance and daily
- calibration as per SOPs, protocols, and schedules
- Verify daily sampling, dispensing of materials and its mass/ volume
- Perform housekeeping of rooms and equipment
Line & Production processing
- Perform line sign on and closure
- Check and authorize packaging line clearance
- Order and maintain substance materials
- Perform batch reconciliations to product specifications and quality
- Monitor production process in line with standards and specifications
Process and system improvements
- Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
- Manage and resolve customer complaints
- Optimize processes and identify gaps in policies/ procedures
Compliance & Auditing
- Conduct shift GMP checks and ensure continued compliance
- Conduct environmental checks and check expiry dates of agents
- Verify good document practice as per SOP and regulation
- Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
- Verify IPCs are in line with product quality and specifications
- Check preliminary batch records
- Audit logbooks and systems
Troubleshooting
- Investigate deviations and concessions and assess risk
- Raise deviations and implement corrective action
- Raise maintenance notifications as and when required
Training and technical expertise
- Train new PMAs on SOPs
- Identify refresher or awareness training needs
Administration & Record keeping
- Complete batch records and labels
- Complete deviation forms as required
- Query documents and sign off declarations
- Perform and verify calculations in BMR
- Maintain and update records and systems as required
Skills Required
Background/experience
- Post Basic registration as Pharmacist Assistant with Pharmacy Council
- 1-3 years’ Pharmacist Assistant experience
- Pharmaceutical manufacturing experience advantageous
Specific job skills
- Basic technical knowledge of pharmaceutical manufacturing, standards, and compliance requirements
- Ability to interpret and implement policies, processes, and objectives
Competencies
- Interrogating information
- Meeting deadline
- Finalizing outputs
- Maintaining accuracy
Method of Application
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