Head of Quality

7 days ago

Middlesbrough, United Kingdom CK GROUP Full time

CK Group are recruiting for a Head of Quality on behalf of a rapidly expanding developer and manufacturer of Active Pharmaceutical Ingredients to be based at their site in Middlesbrough on a permanent basis.
The role:
This is an excellent opportunity to take a leading role within a team, establishing a Quality department and managing and hiring members of the team.
Your Responsibilities as Head of Quality will be as follows:

- To lead and manage the operational performance of the Quality Department (both QA and QC functions)
ensuring the successful delivery of business strategy, KPI’s and objectives, whilst adhering to regulatory
compliance and achieving commercial success
- To be an active member of the site management team representing the quality function and participating
in regular meetings and contributing to the overall efficient operation of the business.
- Coordinating, overseeing and supporting the day-to-day running of the department and allocation of
work.
- Facilitate review and approval of change control and deviation records.
- Oversee Quality Assurance activities; document control; implementation of an EQMS system;
Microbiology and Analytical functions.
- Final product release for products manufactured on site
- Responsible for internal QA audits and lead and support audits (client, internal, external)
- To support all Validation and Qualification activities at the site.
Your background:
To be considered for the position, you should have the following skills and experience:

- A thorough knowledge of cGMP and other regulatory requirements.
- Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related) with
extensive QA experience in the pharmaceutical industry.
- Experience of coordinating and participating in regulatory inspections.
- Excellent project management and communication skills.
It is essential that applicants hold entitlement to work in the UK

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