QA Operations Manager

5 days ago


Elstree, United Kingdom Marketplace Group Full time

International Pharmaceutical Manufacturer seeks an experienced QA Operations Manager.

**The company offers**:

- Competitive salary plus shift allowance
- Bonus Scheme
- Pension
- Life Insurance
- 25 days holiday
- On-site parking and a subsidised restaurant

**About the role**:

- As part of the QA Operations Team, take ownership of all aspects of QA activities relating to the production and QA review of products.
- Leadership of QA Operations team (up to 25 staff, including 24/7 Quality Officer shift support).
- Main Quality contact for QA Operations’ teams.
- Management of key quality processes in partnership with operations, including batch disposition, deviation and CAPA management, on-time delivery, schedule adherence, plasma supply, risk assessments and change control.

**Skills and experience**:

- At least 5 years’ experience in pharmaceuticals or a related industry with significant proportion in a senior Quality or Operational role in Sterile (including lyophilisation and autoclaves) and ideally Biologics
- Strong technical skills with experience of validation and commissioning in sterile environment e.g. autoclaves, filling operations, lyophilisation etc.
- Strong Leadership, management and technical skills
- In depth knowledge of cGmp’s (MHRA, FDA, EU) for steriles, biologics and preferably plasma or blood products
- Demonstrated success and leadership of multifunctional and multi-site teams
- Strong analytical and problem-solving skills
- Demonstratable expertise in executing risk assessments
- Excellent verbal and written communication skills
- Excellent interpersonal / communication / influencing and negotiation skills


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