Senior QA Associate

CK Group
09 Oct 2020
06 Nov 2020
Sarah Farrow
Contract Type
Full Time
CK Group are recruiting for a Senior QA Associate to leading global pharmaceutical company at their site based in Hertfordshire on a permanent basis.

The Company:
Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.

The Location:
The role is based in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable.

Senior QA Associate Role:
The main purpose of this role is to ensure that QA activities relating to the manufacture, packaging, testing, storage and distribution of onsite and third-party manufactured drug products are compliant with current GMP regulations and corporate expectations. You will be responsible for ensuring the integrity of the QMS and processes to support cost effective provision of product and services.

Specific responsibilities will include:

- Deputising for the QA Manager when required.
- Coordinate technology transfer projects, new product introduction or other business driven projects.
- Act as QA lead on local, regional, and global projects.
- Work with other departments to ensure a strong QA culture throughout the business and providing guidance.
- Act as QA Representative within Production Operations.
- Review Manufacturing and Packaging batch records, associated documents and to approve intermediate products.
- Review and approve new and updated master batch records, associated SAP data and any other associated documents.
- Timely and effective resolution of all quality issues to maintain product flow across the global business.
- Provide QA oversight and support for QC activities
- Write, facilitate the review and obtain agreement on all SOPs and training associated with QA activities.
- Participate in internal and external audit process and support competent authority inspections.
- Raise and coordinate the investigation of deviations, incidents and associated CAPA's.
- Raise and support investigations of customer complaints.
- Coordinate the implementation of Change Control activities.
- Complete quality or sponsor assessments of Change Controls.
- Review qualification/validation protocols, reports, and associated documents.
- Coordinate QA support for GDP activities such as assessing returned product, temperature excursions.
- Represent QA on Work Equipment Teams and Continuous Improvement projects.
- Test the effectiveness of EU product recall procedures on an annual basis.
- Identify and implement Continuous Improvement opportunities that result in cost savings and more efficient and compliant ways of working.
- Provide support and coaching to other members of the QO team, as appropriate.
- Perform any other appropriate duties at the request of the Quality Assurance Manager.

Your Background:
To be considered for the position, you should have the following skills and experience:

- Demonstrable experience of working in a QA position in a relevant GMP environment.
- The ability to act as a mentor for a team of QA staff.
- Experience of working in steriles manufacture would be highly beneficial for this position, but not essential.

For more information or to apply for this Senior QA Associate position, please contact Sarah Farrow on 0191 3848906 or, quoting job ref 49046.

It is essential that applicants hold entitlement to work in the UK.

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