QA Specialist
Motherwell
Permanent
£30,000 - £33,000
CDM Life Sciences, working with an emerging immunotherapy company developing cell-based treatments for cancer and severe viral infections, are keen to speak with experienced Quality Assurance Specialists to join our client’s team on a permanent basis. The successful candidate will report directly to the QA Manager.
Responsibilities
1. Provide QA input to activities including review and approval of risk assessments, specifications, Standard Operating Procedures, and other documentation types as required.
2. Review and approve batch manufacturing data sets in accordance with procedures for GMP, prior to passing to Qualified Person for batch confirmation/certification. Where potential issues exist, these are to be highlighted to the QA manager.
3. Participate in review of related investigations/audits/change controls, assist in the development and approval of effective CAPAs to resolve internal and external issues as they arise.
4. Identify and escalate any identified cGMP areas of concern.
5. Provide general support to all Quality unit activities relating to GMP, GCP, and other similar Quality Systems established within the company to ensure that the appropriate standards and effective working systems and relationships are maintained and improved throughout the company.
6. Audit and/or Review GMP validation reports, protocols, reports to ensure that they are internally consistent, accurate, and completely reflect the raw data set and meet the current Good Manufacturing Practice standards and regulations.
7. Be involved in the preparation for MHRA/FDA and other regulatory body audits.
8. Responsible for ensuring the integrity of the company’s PQS and processes to support cost-effective provision of product and services.
9. Perform data integrity audits/checks for GMP, GCP, and non-GxP data as necessary to assure data integrity.
10. Facilitate/perform PQS training, GxP training, and onboarding for new team members where applicable.
11. Identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems.
Skills & Experience
1. Degree/HNC in science discipline or at least 4 years working experience within a Quality Assurance role in a GMP regulated company, preferably in the pharmaceutical, ATMP industry.
2. Knowledge of applicable GMP regulatory requirements and understanding of PQS requirements.
3. Excellent attention to detail with a desire to continually develop and improve our processes and systems.
4. The ability to work effectively within a small team.
5. Ability to learn and share knowledge with all departments.
If you're looking for an exciting new role within a fast-growing company, this could be the opportunity for you. Please apply or contact the CDM Life Sciences team for more info. #J-18808-Ljbffr