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Job Title: Quality Assurance Manager
Location: Ilupeju, Lagos Nigeria
Job Type: Full Time and Permanent
Job Purpose/Scope:
Successful candidate shall be responsible for ensuring that Pharma products are manufactured at third parties and GSK facilities to meet local regulatory standards and GSK Quality Management System requirements
Key Responsibilities:
- Ensure that only wholesome products are manufactured and released to the market
- Manages processes to achieve Right First Time Quality Products and reduced process wastage
- Ensure Quality process documentation and compliance to maintain consistency in batch to batch and in line with regulatory requirements
- Manages Product complaints and returned goods handling and investigation to identify weakness in processes, materials, equipment and methods with a view to eliminating them and improving customer satisfaction
- Manages Change Control processes at 3rd parties maintain Periodic Product Review of Pharma products, so as to ensure that all changes that will impact quality are well considered and appropriate approval sought before changes are implemented
- Manages 3rd party inspection and quality audit processes to assure that Production and Quality processes are in place, effective and complied with at all times ; manage and review CAPAs from L2 audits
- Manages technical transfer and analytical transfer of Pharma products.
- Generates and reviews batch documents and SOPs.
- Collaborates with Purchasing, Logistics and Pharma Commercial for production planning and production execution
- Provides all necessary information required on-time registration of existing and new products by NAFDAC and other relevant regulatory bodies.
- Provides relevant technical information to Regulatory department and other departments in Commercial.
- Support Supplier development programme so as to ensure the quality of all inputs into the production process.
- QMS champion for the Pharma Business Unit overseeing all QMS related activities for the AWA markets reporting to the QMS Co-ordinator, Head of Regulatory Affairs, AWA
Qualifications and Experience
· Bachelor of Pharmacy degree
· Not less than 5 years hands –on experience in the Pharmaceutical production and Quality Assurance operations.
· Additional educational qualification in Pharmaceutics at post graduate level and exposure to Quality Management systems application to Pharmaceutical Quality Assurance is desirable
· Good Communication skills
· Fair knowledge of Engineering and process operations
· Computer literacy
· Competencies• Sound knowledge of manufacturing processes
· In-depth experience and application of Quality Management System
· High level of creativity, assertiveness and bias for problem solving
· Effective leadership skills.
· Computer literacy and good statistical data management
