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Quality Assurance Officer
- Growing Pharmaceuticals Manufacturer
- Quality Assurance
About Our Client
This Cambridgeshire based company are growing significantly & want to ensure that they can continue to meet customer expectations by have excellent Quality standards & by driving continuous improvement. As the Quality Assurance Officer you will be an instrumental member of this fast paced company with excellent positioning in the market place & you have the chance to be part of their exciting journey.
As the Quality Assurance Officer you will be providing direct support to the Quality Assurance Manager working on investigations, conducting self-inspections, supporting the Product Quality Review &Change Control. As part of the QA department you will ultimately be the first line in ensuring that QA regulatory &business requirements are met at all times.
- Ensuring GMP & GDP compliance.
- Coordinate with commercial /Logistics for planning timely release of the batches.
- Ensure batch documentation is obtained & reviewed on timely basis & provide necessary feedback to QPs for batch release.
- Ensure that the batches are in compliance with licence.
- Maintaining QMS and comply to all the requirements like Change control, Deviation CAPAs, Training, Risk management documentation.
- Responding to Quality related market complaints & documentation.
- Sampling, testing and Releases of Packaging Materials.
- Responsible for supporting deviation close out, writing investigation reports and initiating/following up on corrective and preventative actions.
- Leading Quality based projects working as part of a multidisciplinary team as required.
- Responsible for supporting quality related customer complaint investigations and trending activities.
- Supporting the development and implementation of improved quality reporting measures.
- To promote continuous improvement of the Quality Management System.
- Able to provide training in all aspects of Quality Management Systems and GMP including procedural updates.
- The generation of Product Quality Reviews.
- The generation of Technical Agreements and Summary of Finished Product Specifications as appropriate.
- Supporting the review of all batch related documentation.
- To support and maintain Business Continuity Management Plans and Environmental Health and Safety requirements as applicable to the QA Department.
The Successful Applicant
A Quality Professional with Pharmaceuticals manufacturing experience & the following:
- Ideally educated to Degree level
- Knowledge of EU quality related pharmaceutical regulations
- Experience of conducting quality based investigations & root cause analysis
- Experience of conducting inspections
- Understanding of Product Quality Review requirements
- Understanding & experience of Change Control
- Good communication skills
- Strong IT skills including MS Office
What's on Offer
Circa £27,000 - £30,000 + Benefits