Qualified Person & QA Manager required to join an External Manufacturing Organisation (EMO) -Global Pharmaceutical MNC
The successful candidate will ensure that the highest standards of Quality Operations are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.
The role will encompass formalised release and certification activities across global markets.
Main responsibilities and tasks
- Take charge of Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
- Responsibility for introduction of the Quality Auditing capability with use of CAPAs to identify and track required improvements.
- Ensure that critical quality issues are reported to company management strictly following company policy & procedures
- Approve & sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
- Carry out the disposition of Finished Products, APIs, Raw Materials and Components
- when required.
- Advance a quality strategy aligned with the overall business strategy
- Assuring the batch has been manufactured and checked in accordance with the principles and guidelines of GMP & any other legal requirements.
- Product Certification & Release in accordance with relevant legislative provisions
Experience & Qualifications:
- Degree in science or related field
- 6+ years hands-on experience in QA & QC
- Solid supervisory experience
- Prior experience working on the QP licence
- Wide-ranging experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments.
- Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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