QA/QC Manager
Adexen
Nigeria
26d ago

Job description

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.
  • Expectations

  • Bachelor's degree in Pharmacy or other related field
  • Minimum of 6 years experience with a multinational 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.
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