Quality Assurance Officer/ Administrator, Pharmaceutical
Location: Bolton area
Type: FTC 12 month (has the potential to go permanent)
Salary: £20,000 CIRCA
Additional: Parking onsite, company pension scheme
Our Client, a leading Pharmaceutical manufacturing organisation; is looking to recruit a QA Officer who will play a vital role in the transition of their new QMS system and move to a more efficient - electronic based system. Whilst initially listed as a 12-month FTC; this role has the potential to exceed this and will provide the successful candidate with all the training and tools to succeed in an GMP - MHRA QA setting.
If you are working in a QC - Hybrid QA role or on the fringes of QA, then this would be a viable move into QA and a perfect opportunity to develop those skills:
To support the Quality Assurance Manager in the management and maintenance of the QMS and supporting the batch review and release function/s by:
Complying with company policies and procedures on GMP, EHS and company employment.
- Ensure that appropriate General, COSHH and Manual Handling risk assessments are in place and adhered to.
- Work with department managers to prepare Technical Agreements.
- Maintain the Technical Agreements matrix.
- Compilation of Product Quality Review for licensed products.
- Prepare, execute and update the annual Product Quality Review Schedule.
- Collation of manufacturing, packaging and QC batch documentation completed packs.
- Review of batch documentation ensuring all required investigations complete and EudraLex Volume 4, Annex 16 requirements are met.
- Liaise with Planning/Sales to effectively prioritise batches and manage batch review process flow.
- Tracking, maintenance and continuously improving the Pharmaceutical Quality System.
- Develop, implement and review company PQS procedures and practises.
- Write and update Standard Operating Procedures as required for new processes and periodic reviews.
- Perform Risk Assessments where necessary, using recognised risk management techniques.
- Perform tasks around serialisation e.g. reconciliation, closure of works orders, set batch release status and check system for hub alerts.
- Cover for QA Administration in the event of sickness and holidays.
- Will hold a Degree in a relevant/ Scientific discipline
- Will have some exposure to QA in an MHRA setting (CAPA, OOs, SOPs, Deviations etc)
- Ideally will have some process validation experience but not essential
- Solid Excel/ IT skills needed for this role
- Strong interpersonal skills, to be able to liaise with the senior stakeholders onsite