Job Description: Quality Assurance Manager
Job Description Number: JD-017-03
Job Title Quality Assurance Manager
1. PURPOSE OF THE JOB
To manage Quality Assurance function to ensure that Site Operations are carried out in
compliance with current Good Manufacturing practices.
2. KEY RESULTS AREAS
1) To select, train, motivate and develop both team and individual performance using
the appraisal, communication and HR systems
2) To prepare, agree and monitor departmental budgets to ensure that spend is in
line with business objectives.
3) To assess current and developing regulations and regulatory position in order to
develop and implement changes within the business to ensure continued
4) To contribute to the development of quality policy and awareness at Teva
5) To review & approve validation activities & documentation on the introduction of
new processes or changes to process to ensure regulatory requirements are
6) To prepare Annual Product Review, and identify and implement corrective actions
to ensure quality/regulatory requirements are met.
7) To review and approve batch manufacturing documentation within agreed
timelines to support product release
3. AREAS OF IMPACT AFFECTING THE JOB
• Headcount of 5 - staff performance
• Budget £0.2k
• Site cGMP Compliance
• Product approval & release - achievement of Product Approval Plan
• APR Process
• Non-conformance investigation & close out
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4. PLANNING, ORGANISING & CONTROLLING
Staff performance plans - annual, quarterly review
Achievement of objectives in line with own performance plan - annual, quarterly
Budget/Forecast -annual, monthly
Delivery of project milestones - as agreed
Product disposition - monthly
Changes control review meeting - monthly
Day to day activities on as need basis
5. CONTACT WITH OTHERS
Site Management Team for review of Operational, Quality and Business
performance via formal meetings and informal meetings to ensure Quality, Business
and Operational issues/tactics are monitored and kept in focus.
Finance - Product disposition
QA & Q Compliance staff - Technical agreement
NPD - stability trials /investigations
Departmental/functional Managers/Supervisors/any other employees as necessary,
formally and informally, to progress operations, projects, resolution of issues and
future planning requirements.
External regulatory personnel during audits for regulatory compliance, etc.
QA Operations Team to provide leadership and focus on functional
issues/performance on a formal basis as well as informally but in real time.
6. DECISION MAKING AUTHORITY
Control of budgets
Acceptability of data
Staff selection and deployment
Approval for all change control activities
Review & approval of data
Product approval and release
Acceptability of manufacturing /utilities - environmental and cGMP issues
Changes to processes & systems
7. KNOWLEDGE, SKILLS AND DIMENSIONS
Minimum Qualified to Degree level or equivalent in Science. Corporate
Qualifications/ membership of appropriate professional body. Eligibility to be registered
Experience as a Qualified Person.
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Knowledge Experience in a Quality Management role with experience as a Quality
Assurance Manager in a modern manufacturing environment within the
pharmaceutical industry (operating steriles to FDA/EU/ISO9000
Experience in the Management of Change, Project Management,
Budgetary Management and continuous improvement of people/process
in bringing about cultural change.
Skills A good communicator and team worker with the ability to set and deliver
high performance standards relating to Quality, Safety, cost and
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