Hobson Prior are currently are recruiting for an exciting opportunity for an QA Manager / QP to join an integrated pharmaceutical organisation who provide affordable and ground-breaking medicines for healthier lives. The QA Manager will lead the QA department to maintain and improve quality and compliance across the DRLUK EU Generics business.

Job Responsibilities:

• Accountable to set the strategic direction of the UK Quality department in line with EU and Company Strategy.
• To effectively manage people resources to comply with GxP to provide the required level of service and RFT.
• Ensure the QMS is managed to be current, compliant and effective, including managing the audit programme and providing guidance on Regulatory compliance.
• Communication with regulatory agencies, MHRA and managing quality issues on a risk-based approach within compliance requirements.
• Batch certify and/or release for sale Medicinal Products to market or to the Customer ensuring that they have been manufactured in accordance with the principles and guidelines of GMP.
• Manage budget requirements for function.

Key Skills:

• You are motivated to achieve and sees opportunities for growth.
• Ability to multi-task and prioritise, excellent attention to detail. Can critically evaluate and analyse complex problems to successful resolution.
• Ability to drive collaborative working with internal teams, effective communicator across all levels, cross functionally and experience across continents/cultures.
• Takes ownership for end results and outcomes.

Requirements:

• University degree (or equivalent) in a Life Science.
• A minimum of 5 years' experience in Quality Management
• Qualified Person with OSD/Steriles experience.
• Direct experience with the MHRA including inspections.
• Knowledge of the requirements for a Responsible Person Importation.
• Knowledge of applicable regulations and directives, GMP/GDP, Quality Management Systems, Auditing in UK and EU.
• QP status (Permanent provisions under 2001/83/EU).
• Auditing experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.