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Adexen is mandated by one of its clients in the FMCG/Pharmaceutical industry to recruit a QA/QC Manager. The position is based in Lagos, Nigeria.
Our client is a major player in the Manufacturing industry with specialisation in pharmaceutical products.
The purpose of the role is to lead, manage, deliver, develop and evaluate pharmaceutical QA/QC services.
MAIN DUTIES AND RESPONSIBILITIES:
- Critically evaluate Quality systems to ensure that best practice is promoted
- Prepare, approve, monitor and review specifications for starting materials, finished products and packaging materials to ensure compliance with Good Manufacturing Practice.
- Approve, monitor and review critical documentation such as Master Production worksheets and Standards Operating Procedures and associated documentation.
- Review test methods for chemical and microbiological testing.
- Manage the maintenance and further development of microbiological, physical and chemical monitoring programmes for all production and storage environments, equipment, processes, and staff.
- Establish sampling procedures to select or secure samples in accordance with specifications.
- Generate Certificates of Analysis on request to support the external supply of medicinal batch products.
- Establish storage requirements and evaluate storage conditions
- Undertake and sign off risk assessments and develop options to manage risk within technical services.
- Ensure that stability data is established and stability data files are maintained to support shelf lives and storage conditions assigned to each product prepared.
- Maintain, and ensure compliance with any accreditation obtained by QA/QC staff.
- Ensure that all medicines manufactured are made in accordance with relevant National and Regional guidelines and policies.
- Responsible for ensuring that Health & Safety are complied with and advise on safety issues as they relate to the use of chemicals.
- Develop, implement and monitor systems to ensure that all information required to run the Quality Service is in place.
- Lead risk assessment and documentation of major changes made to the Pharmacy Manufacturing services.
- Bachelor's degree in Pharmacy or other related field
- Minimum of 20 years experience with a Pharmaceutical Company
- Experience in pharmaceutical manufacturing
- Experience in a QC Laboratory and a QA Department
- Experience of managing and developing a Quality Service
- Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
- High level of work organisation, self-motivation, drive for performance and improvement, and flexibility in approach and attitude
- Excellent verbal and written communication skills.