My Client a Global Pharmaceutical Company has opened a new vacancy within there Regulatory team and are looking to recruit a Senior Regulatory Executive- CMC...
Product Quality Manager (Sterile Pharmaceuticals)
Competitive Salary + Excellent Benefits
Based in London
Do you have extensive experience within Manufacturing Quality Assurance?
Would you like to work for a expanding pharmaceutical organisation in London?
As the quality manager, you will be directly responsible for the review, release, testing and environmental controls for the relevant production stream of sterile pharmaceutical products. This position will involve managing a team of quality staff, including QA executives, batch review staff. You will ensure the continued compliance with all regulatory and Quality Management Systems requirements.
Key Responsibilities Will Include:
- Maintain a thorough understanding of international regulatory, ISO, corporate and client requirements pertinent to the department and to ensure that all work within the department and across the plant complies with these and with departmental procedures
- Ensure that all tasks are carried out in an effective and efficient manner to meet budgetary requirements
- Resource the department to ensure compliance with regulatory, cGMPs, ISO, site procedures, corporate and client requirements, including lead-times
- Ensure that all members of the department are adequately trained, to train others as required, and to ensure that appropriate training records are maintained for the department Ensure that all health and safety procedures within the department are adhered to with respect to personal duties and the duties of others
- Manage internal and external audits where required. Be present at regulatory or client audits
- Assure quality problem solving ensuring GMP compliant and pragmatic solutions are in place
- Liaise with all Departments to provide a timely and efficient service for our internal and external clients
To be considered for the role you will need substantial experience of QA and Quality Operations with an in-depth working knowledge of GMP requirements. This could be from the Medical Device, Healthcare, Pharmaceutical or releated industries. This will need to be backed up by proven effective management attributes with experience of managing cross-functional teams. Ideally you will have experience in sterile manufacturing or powders, although this isn't essential for the right candidate.
You'll be dynamic & self-motivated, with a pro-active approach to taking on challenging assignments. Demonstrating creativity, judgement and analytical thinking you'll work with critical time-lines, planning effectively to envision short-term milestones which the company must achieve to succeed in the long-term.
You'll need outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
KEY WORDS "QA, Quality Assurance, GMP, regulatory, pharmaceutical, sterile, powder, ISO, compliance, auditing, management, QA Manager, QMS, Quality Management Systems"
Please apply on-line or call Neil Walton on 02030964706 for more details.