Duties and Responsibilities
Critically evaluate Quality systems to ensure that best practice is promotedPrepare, 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 conditionsUndertake 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 fieldMinimum of 20 years experience with a Pharmaceutical CompanyExperience in pharmaceutical manufacturingExperience in a QC Laboratory and a QA DepartmentExperience of managing and developing a Quality ServiceDemonstrated ability to identify problems, analyse root cause and propose solutions for complex problemsHigh level of work organisation, self-
motivation, drive for performance and improvement, and flexibility in approach and attitudeExcellent verbal and written communication skills.
Method of Application
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