QA/QC Manager at Adexen

Job Reference: 1390
Industry: FMCG
Function: Quality & Inspection

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 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.