Quality Assurance Associate - Hertfordshire
Jocelyn Blackham at CK Science is currently recruiting for a Quality Assurance Associate a join a global pharmaceutical research company with Commercial, Discovery, Clinical and Manufacturing business units collated on a single site in Hertfordshire on a full time, 6 month fixed term contract.
The key purpose of this role will be to support Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage and distribution of company and third party contract manufactured drug products, ensuring compliance with current GMP, company Quality Systems, Corporate expectations and Industry Standards. The role will support the review and writing of quality policies, systems and procedures as required and will work with Supply Chain, Planning, Technical, Manufacturing, Packaging, Quality Control, Regulatory Affairs, Network Companies and Third Party Contractors to ensure that schedules for the release and distribution of products are met.
Your main responsibilities in this role will be to:
- Review the Company and Third Party Packaging Batch Records, associated documents and to approve intermediate products.
- Review and approve the Company and Third Party Manufactured Bulk Batches.
- Support approval of new and updated Company and Third Party Master Batch Records and any other associated documents.
- Support the collection of data for reporting QA Performance Indicators.
- Act as QA Representative within Production Operations.
- Support approval of SAP Material Master data, Bills of Material (BOMs) and other SAP related processes.
- Support the QA review and approval of appropriate QC documentation.
- Write under supervision, all SOPs associated with QA activities relating to product support.
- Complete the Quality Approval of SOPs.
- Participate in the internal and external audit process and support competent authority inspections.
- Raise and support the investigation of incidents, deviations and associated CAPA's
- Complete the QA Assessment of Deviations and CAPAs.
- Raise and support the investigation of customer complaints.
- Support the implementation of Change Control activities.
- Review qualification/validation protocols, reports and associated documents.
- Support technology transfer projects and new product introduction.
- Support GDP activities such as assessing returned product, temperature excursions.
- Maintain current TSE files on each marketed product.
- Represent QA on EML Work Equipment Teams and Continuous Improvement projects.
- Support testing the effectiveness of the Company's 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 to other members of the QO team, as appropriate.
- Perform any other appropriate duties at the request of the Quality Assurance Manager and EMEA Quality Operations Senior Director.You are required to have the following qualifications, skills and experience:
- Knowledge and experience of Quality Assurance, Quality Systems, GMP and a basic understanding of manufacture and packaging of pharmaceutical products
- The ability to develop the knowledge and experience of relevant pharmaceutical quality management relating to marketed and clinical trial manufacturing and packaging.
If successful, you will be joining a company that truly values its employees and is completely focused on the patient. In return there is an attractive salary, coupled with excellent benefits and extensive training/career progression opportunities.
For more information or to apply for this Quality Assurance Associate position please contact Jocelyn on +44 (0)1438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who 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 ST33495 in all correspondence.