Senior Quality Assurance Associate - Hertfordshire
Jason at CK Science is currently recruiting for a Senior Quality Assurance Associate to join a patient focussed pharmaceutical research company with Commercial, Discovery, Clinical and Manufacturing business units collated on a single site in Hertfordshire on a full time, permanent basis.
This role is responsible for ensuring Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage and distribution of Company and Third Party manufactured drug products are compliant with current GMP and Company Corporate expectations. It will provide input into the enhancement of quality policies, systems and procedures as appropriate and take responsibility for ensuring the integrity of the company QMS and processes to support cost effective provision of product and services.
Liaising with Supply Chain, Planning, Technical, Manufacturing, Packaging, Quality Control, Regulatory Affairs, Company Network Companies and others, the role will ensure that Company schedules for the release and distribution of products are met. It will also ensure that operations are carried out in accordance with the requirements of the Company Quality System, GMP Guidelines and Industry Standards.
Your main responsibilities in this role will be to:
- Review Company and Third Party Packaging batch records, associated documents and to approve intermediate products.
- Review and approve Company and Third Party Manufactured Bulk Batches.
- Review and approve new and updated master batch records, associated SAP data and any other associated documents.
- Act as QA Representative within Production Operations.
- 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.
- Complete the QA Assessment of Deviations and CAPAs.
- Raise and support investigations of customer complaints.
- Coordinate the implementation of Change Control activities.
- Coordinate technology transfer projects, new product introduction or other business driven projects.
- Coordinate QA support for GDP activities such as assessing returned product, temperature excursionsYou are required to have the following qualifications, skills and experience:
- Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP and an understanding of manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Diplomatic, self motivating, professional with problem solving and decision making capabilities.
- Good communication skills at all levels and in an appropriate way.
- Developed presentation skills.
- Computer literate e.g. Word, Excel and PowerPoint.
- Ability to interpret and translate GMP Guidelines into effective business processes and procedures.
- The ability to act as a mentor in support of staff development.
- Demonstrate initiative and creative thinking
If successful, you will be joining a well respected Pharma company with a Global presence that truly values its employees and is completely focused on the patient. You will report directly to the QA Manager and will make a real difference to patients lives.
For more information or to apply for this Senior Quality Assurance Associate position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. 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 ST35615 in all correspondence.