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
Review test methods for chemical and
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
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 and Safety
are complied with and advise on safety issues as they relate to the use of
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
Minimum of 6 years experience with a multinational
Experience in pharmaceutical manufacturing
Experience in a QC Laboratory and a QA Department
Experience of managing and developing a Quality
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
Excellent verbal and written communication skills.
here to apply