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 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.