Our longstanding pharmaceutical business based in Cramlington are looking for a Quality Technician to join the Product Release Coordinator team. The ideal candidate will have experience in a laboratory from a cGMP business or have good experience in validation from a regulated environment. The role will work in the Packaging & Manufacturing division, you will be responsible for deviation analysis, customer complaint investigation and batch documentation review. This is an excellent opportunity to join a market leader as you further your career in a varied escalations role within a pharmaceutical business. Training is excellent and you will be well supported to get up to speed with internal systems.
- Perform real time document checks & reviews.
- Support packaging processes by providing quality input into documentation and compliance concerns during routine running operations.
- PMO review for manufacturing and packaging and approval of manufacturing work orders.
- Perform GMP review of batch records and associated data, including review of regulatory impact tables.
- Perform GMP review of Toller batch records and associated data, including review of regulatory impact events.
- Support Q-shipment process by liaison with receiving sites and ensuring appropriate documentation is retained with batch documents.
- Investigations – provide quality assistance and input to manufacturing deviations and customer complaints as required.
- Formula review (template) & approval.
- Review and approve equipment change control.
- Equipment qualification documentation QA review.
- Approval of SOP’s.
- Audits and self inspections – support.
- Measure and provide input and assistance to improve RFT (right first time) metric.
- Improving own business processes.
- Safety of self and others.
Qualifications, Skills and Experience
- At least 3 years’ experience in the pharmaceutical industry.
- Good written and spoken communication skills and ability to lead cross-functional teams.
- Ability to form good working relationships with other functional groups.
- Attention to detail and well-organised approach to working.
- Degree/HNC in Chemistry, Pharmacy or other scientific statistical discipline is preferred.
- Previous experience of validation, change control, stability work is preferable.