Quality Systems Associate

Posted 5 days ago by CK GROUP
Easy Apply
James Horne at CK Science is recruiting for a Quality Systems Associate to join a company in the pharmaceutical industry 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 at our client's site 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. Hertfordshire boasts many landmarks as well as beautiful countryside.

The Role:
The main purpose of the role will be to:
- Ensure that operations carried out within the Quality Systems section are completed in accordance with the requirements of the departmental Standard Operating Procedures.
- Support the effective running of the Product Quality Review and Quality Agreements as well as Complaints, Deviations, Parallel Imports, Risk Management, Qualification and Validation, Training, Standard Operating Procedures, Internal and External Audits and Approved Supplier Systems.
- Ensure that the Electronic Quality Management System (QMS) and any associated systems used for the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations.

Further responsibilities will include to:
- Provide input to the review and writing of any associated quality policies, systems and procedures as required.
- Support the generation of routine status and performance reports covering aspects of the Electronic QMS.
- Support the Senior Manager Regional Quality Systems with activities related to the maintenance of the Regional Quality System for the Europe, Middle East and Africa (EMEA) region, to ensure that products are managed and distributed in line with the Regional Quality System Procedures.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in life sciences with good technical and scientific judgement and extensive knowledge of Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products.
- A good understanding of PQRs (Product Quality Reviews) and Quality Agreements is key.
- The ability to establish and maintain effective working relationships and communication links internally and with affiliated organisations and other customers as well as having problem solving and decision-making capabilities and good communication skills.
- Demonstrated knowledge, understanding and application of GMP Guidelines and Regulations.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47162 in all correspondence.


Reference: 39499962

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