Our client, a major pharmaceutical manufacturer is keen to recruit a Quality Assurance Officer for their operation in the north west.
Salary £26-28,000
2. PURPOSE OF THE JOB
To develop, implement and maintain quality standards and systems to ensure that products comply with Marketing Authorisations, specifications and cGMP
3. KEY RESULTS AREAS
1. To support manufacturing and other operations in the development, implementation and maintenance of cGMP standards Audit
2. To identify, design and deliver cGMP training to support improved application of cGMP standards Training modules, Training Records, Training Plans
3. To review and approve quality documentation to ensure compliance with cGMP Audit
4. To prepare and complete product quality reviews to ensure compliance with regulatory requirements Product Quality Review
5. To close out failure investigations and preventative actions to reduce repeat failures Non Conformance Investigations/Reports
6. To review and approve batch manufacturing documentation within agreed timelines to support product release
7. To carry out audits to support the identification, actioning and close out of non-compliance issues Audit schedule
Audit actions
4. AREAS OF IMPACT AFFECTING THE JOB
cGMP
cGMP training
Product Quality Reviews
Internal Audit Plan
Non Conformance Investigation
5. PLANNING, ORGANISING & CONTROLLING
Objectives and goals in line with performance plans
Day to day work load and prioritisation of activities
Planning horizon 12 months - Apr, Audit schedule
6. CONTACT WITH OTHERS
Internal : Members of other departments to support application of cGMP
QA - functional issues
QA Officer - provision of training where required
External: Regulatory authorities - auditors
Vendors/suppliers
7. DECISION MAKING AUTHORITY
Recommendations on release, rejection or rework of product
Resolution of quality issues in conjunction with line management
Day to day need in line with policy and procedures
8. KNOWLEDGE, SKILLS AND DIMENSIONS
Minimum Qualifications/Experience
ONC in scientific discipline or equivalent
5 years in pharmaceutical industry in similar role
Ideally degree qualifications in scientific discipline
Knowledge
Skills
Competencies
9. OTHER INFORMATION (Standards to be complied with as appropriate)
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