Quality Assurance Manager - Pharmaceutical
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the The Company Pharma Quality Manual and is conducted according to the relevant SOPs.
• Lead External Suppliers Qualification process.
• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier
• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the The company Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
• Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between The company and the External Supplier, as well as Product details and requirements.
• Request, review and process GMP documentation as defined by the Quality Agreement and The company SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
• Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the The company Quality Manual – maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the The company Quality Manual. Ensure investigations are correctly executed.
• Escalate any issues or instances of instability per the The company escalation policy, and initiate any market action that is required. Support / participate in The company Emergency Management cases as required.
• Ensure that Change requests, either from the External Supplier or from The company, are managed according to the Quality Agreement and The company SOPs from receipt, through to the implementation and closure.
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.
• Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.
Within the organization
• Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
• Ensure that the QA Lead and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse affect on the quality of the product at an External Supplier.
• Together with the Supplier Relationship Manager provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole – Participation in the Business review of External suppliers.
• Participate in the Reporting on QA External Supplier activities – this is to include Risk Assessment, reporting and managing of defined KPI’s.
• Ensure that coordinated contact is maintained with other functions within The company also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
• Participate in the ESO Quality Plan – ensure that all quality issues at External suppliers are included in this plan.
• Participate in projects as defined and ensure that all aspects are implemented and followed up
• Maintain current knowledge of local and international regulatory and legislative requirements and trends
Key Performance Indicators:
• The number and severity of cGMP issues identified during internal Global Quality Organization and Health Authority audits of External Supply QA and the External Supplier
• Compliance of products according to agreed specifications
• No out of stock incidents related to QA activities
• Training plans in place with training conducted, assessed and documented
• Execution of responsibilities in a timely and efficient manner
Education: Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another related science
Languages: Fluent in speaking / writing in English
• 10-15 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
• Thorough knowledge of cGMP requirements
• Strong understanding of regulatory requirements for commercial products
• Proven track record with applicable Health Authorities.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Strong Technical understanding of pharmaceutical processes
• Team and consensus builder, with definitive and authoritative decision making ability
Send your CV to email@example.com
Shortlisted candidates will be contacted within 2 weeks.