Latest Jobs at Aspen Pharma Group

Description

• Review and approve batch documentation in line with SOP and quality standards.
• Perform lab quality review in line with SOP.
• Provide services according to Production plan.
• Related administrative tasks.

Requirements

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert.
• Optimize and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques.
• Provide information for reports, as required by superior.
• Provide analytical support in the absence of the TL.
• Provide support during regulatory audits.

Lab Quality Review

• Perform LQRs according to Production plan.
• Review and approve lab records to ensure pharmaceutical.
• analysis has been carried out as per MOA, direct queries to laboratory.
• Electronic approval of analytical results on relevant software. e.g. Empower
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards.
• Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
• Record all OOS investigations and conclusions, and report to management.
• Provide advice to analysts during laboratory investigations.
• Provide input into SOPs.
• Ensure that products are produced, tested, and stored according to the required SOP’s and documentation.
• Ensure adherence by Analyst/ Tester before release.

Reporting and Record Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations.
• Compile detailed and standardized reports and consolidated documents.
• Initiate deviations once picked up during reviewing.

Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 6+ years’ experience
• Laboratory experience

Specific job skills

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.
• Strong technical knowledge and be competent in the use of all.
• laboratory equipment, software, and techniques.

Competencies

• Interrogating
• Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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Description

• Perform QC and stability tests on raw materials, in process and finished products, components and water to ensure quality and compliance.
• Review compliance of products to GMP, quality standards, and product specifications.
• Provide services according to Production plan.

Requirements

Planning and Operational Support

• Optimize and facilitate implementation of current processes.
• Propose changes or improvements to processes, tools, and techniques.

Test Preparation

• Prepare and analyze samples according to SOPs.
• Prepare and operate laboratory equipment according to SOPs.
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results.
• Prepare reagents and solutions for testing.
• Maintain good housekeeping.

Testing

• Perform HPLC/GC analysis using MOA.
• Perform routine analysis on in process and final products, raw materials, and components.
• Perform routine stability tests such as related substances, assay, and dissolution to assess quality of product.
• Perform daily and weekly water testing according to SOP.
• Support testing for OOS investigations to establish any systematic issues in process or testing.
• Handle problems efficiently according to quality policy
• Report feedback on services or outputs regularly to customers
• Check HPLC/GC runs regularly during the shift.
• Provide internal customers with accurate HPLC/GC results.
• Propose, develop, and update methods for improving customer service.
• Check, document, and report operational output against actuals.
• Communicate deviations for production and process improvements.
• Utilize technology as per qualification requirements.

Reporting and Record Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations.
• Record, interpret and report testing results to management, including OOS results.

Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 2+ years’ experience
• Laboratory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Knowledge of Millennium Software (HPLC) and GC Software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Interrogating Information
• Meeting Deadlines
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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Overview

• Manage and support product processes and outputs.
• Long term production and shift planning.
• Problem identification and solution engineering.
• Manage and guide production staff through team leaders.
• Performance management of direct reports, monitoring of performance management within department.
• Reviewing and approving production instructions, validation and qualification of manufacturing equipment and tools.

Responsibilities

Planning and Unit Management

• Provide technical and operational input into processes, procedures and policies.
• Coordinate the communication, management and implementation of strategic plans and monitor implementation.
• Build and maintain relationships with internal and external stakeholders.
• Develop, implement and monitor Focus Factory operating budgets.
• Ensure availability and optimal allocation of resources within unit.  
• Perform HR for optimal management of unit.
• Empower subordinates through training, information sharing, coaching, feedback, appraisals and delegation to ensure the development of people, teams and organisational capabilities.
• Attend production, quality and safety meetings.

Production Planning and Process Management

• Ensure operational excellence with regards to safety, quality and productivity of the Focus Factory and its ability to deliver high levels of service to internal and external customers.
• Manage people, materials, equipment, business and manufacturing processes to deliver Factory performance objectives as measured by Factory KPIs.
• Ensure compliance with policies / procedures for shift rotation, vacation scheduling and training to meet business needs including peak production periods.
• Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers.
• Ensure effective implementation of new technology and products.
• Implement TPM and other continuous improvement programs.
• Develop and implement CAPEX budgets.
• Ensure integrity of business processes related to finished goods inventory replenishment and new product introductions.

Governance, Risk and Compliance

• Ensure adherence to and compliance to regulatory requirements.
• Ensure that appropriate validations are completed as per validation requirements and schedule.
• Initiate and set targets and review GMP, quality and training needs.

Requirements

Skills Required

Background/experience

• Minimum of Bachelor’s Degree in Pharmacy / Engineering / Chemistry with 10 years’ related experience.
• Pharmaceutical manufacturing experience.
• Project Management experience.

Specific job skills

• Strong working knowledge of Pharmaceutical manufacturing.
• Problem solving and solution engineering.
• Pharmaceutical standards and compliance requirements.
• Coaching, leadership and mentoring.
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Offering insights
• Making Decisions
• Managing Performance
• Customer Awareness
• Developing others

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Overview

• Drive the implementation of production, activities and take accountability for the meeting of production targets.
• Problem identification and solution engineering.
• Ensure OTIF delivery within cost budgets.
• Lead and drive outputs of the following units: Production, QC, HR, Production planning and Maintenance.

Responsibilities

 Operational Activities

• Lead and inspire all the personnel on the site – with a specific focus on the management team to ensure that they are aligned on the outputs and service promised in line with an agreed plan.

• Drive the site strategy deployment process.
• Define the vision, mission and objectives for the site and make sure that there is a high level of engagement from all employees.
• Responsible for management of manufacturing operations on the site
• Make sure that technological upgrades of site are encouraged and duly implemented (through proper coaching, training, better skills, and better behaviours).
• Ensure all demand is appropriately planned to meet supply requirements.
• Lead a performance driven organization.
• Ensure compliance at the site. Keep improving the quality standards and ensure strong compliance standards with external regulators. Ensure compliance in the areas Quality, SHE, Legal, IT, HR, Financial and others critical areas for the manufacturing business.
• Understand the commercial relevance of the sites output in terms of the customers, supply chain and products manufactured at the site.
• Develop people on site to ensuring a strong talent pool, actively participate in talent management activities.
• Ensure all managers can deliver on their responsibilities.
• Ensure the quality of relationships with unions with a culture of transparency. Support the actions around ER/IR climate.
• Build budget / P & L and ensure management of operational expenses (CAPEX/OPEX)
• Ensure the competitiveness of the factory (COGS)
• Represent the site in regards of all relevant authorities

Production Planning and Process Management 

• Ensure operational excellence with regards to safety, quality, and productivity of the Focus Factory, and its ability to deliver high levels of service to internal and external customers.
• Manage people, materials, equipment, business, and manufacturing processes to deliver Factory performance objectives, as measured by factory KPI’s.
• Ensure compliance with policies/procedures for shift rotation, vacation scheduling, and training to meet business needs including peak production periods.
• Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers.
• Ensure effective implementation of new technology and products.
• Implement TPM and other continuous improvement programs.
• Develop and implement CAPEX budgets.
• Ensure integrity of business processes related to finished goods inventory replenishment, and new product introductions.

 Governance, Risk and Compliance

• Ensure adherence and compliance to regulatory requirements.
• Ensure that appropriate validations are completed as per validation requirements and schedule.
• Initiate and set targets, and review GMP, quality and training needs.

Requirements

Background/experience  

• Minimum of Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience
• Managing a Strategic Production site
• Proven Leadership Capability and Managerial Experience

 Specific job skills

• Strong working knowledge of Pharmaceutical Manufacturing
• Problem Solving and Solution Engineering
• Pharmaceutical standards and Compliance requirements
• Coaching Leadership and mentoring
• People and Departmental management
• Deep understanding of quality, operations, and logistics 

Competencies  

• Customer Awareness
• Translating Strategy
• Making Decisions
• Managing Performance

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Overview  

• Design and set Quality Policy and drive overall strategic direction for compliance to Quality and GMP standards and product specifications.
• Lead continuous alignment of pharmaceutical quality system in line with current and future global GMP and legal requirements.
• Develop systems to ensure that the SA Operations management team monitors compliance to pharmaceutical quality system and to lead GMP improvement initiatives.

Responsibilities

Compliance and continuous improvement

• Strategically action and mitigate GMP regulatory audit results and outcomes.
• Ensure policy and SOP compliance of facilities.
• Improve quality standards, integrating feedback from direct reports and from external regulators. 

QS Management

• Oversee the condition and relevance of the overall quality system.
• Guide in the formulation and maintenance of QS-related policies and procedures.
• Oversee the systems associated with deviation management, CAPAs, document control, quality risk management, root cause analysis, change control, the handling of product failures, and the recording and trending of related data.

QA management

• Oversee the management of quality procedures, standards and specifications and core QA activities for value streams.
• Ensure QA programs and activities are strategically aligned.
• Provide guidance and oversight in product release, retention sample management and in-process quality management.

QC management  

• Provide oversight for QC processes, including lab testing, customer service and deviation investigations, ensuring legal and regulatory compliance.

Vendor and audit management

• Ensure that supplier base is compliant with legislation, corporate policies and GMP standards and is capable of supplying cost-effective, high-quality services.
• Take responsibility for internal corporate and supplier audit programs.

Organisational support and function management

• Participate in the development and lead the implementation of the strategic vision and direction for business-critical functions across SA, as well as all related plans, policies and procedures.
• Perform financial and human resources functions to ensure optimal management of function and reporting units and their leaders.
• Manage collaboration and coordination between reporting units.
• Maintain and support positive customer engagements and problem resolution.

Requirements

Skills Required

Background/experience

• Minimum of Bachelor’s Degree in Pharmacy
• 8 – 10 years’ relevant managerial experience in a quality assurance environment.
• 5 years’ experience dealing with local and / or international regulators and audits.
• Project Management qualification / course will be an advantage. 

Specific job skills

• Subject matter expert on GMP, QS, Policies and Procedures
• Computer Literacy (Microsoft Office)
• Proven people and departmental management

Competencies

• Translating Strategy
• Interpreting and Internalising Information
• Managing Performance
• Customer Awareness
• Making Decisions