Quality Compliance Officer, Pharmaceutical
Location: Letchworth (onsite)
Hours: Monday - Friday (either 8:30 - 16:30 or 9:00 - 17:00)
Salary: Competitive DOE
Additional: Company pension, discretionary bonus, private healthcare plan, 25 days hol + BH
Our Client, a cash rich SME that are experiencing significant growth at this point and extending their product portfolio; is looking to recruit for an experienced QA professional who will assume responsibility of the QA function/s and play a key role in the continued development of the QMS.
General Job scope: Ensure company GMP and GDP compliance.
This is a desk-based role, with occasional travel. It also requires close working with scientific, manufacturing and medical personnel within the company, its group companies, its suppliers and its contract service providers.
- Maintain the company's Quality Management System.
- Monitors performance against quality compliance objectives.
- Maintain schedule of routine GMP and GDP compliance activities.
- Maintain schedule of routine non-GMP and GDP compliance activities (eg, Home Office licencing).
- Create and maintains assigned SOPs.
- Monitor ongoing product supply standards against registered and specified details.
- Identify compliance gaps and make recommendations for continuous improvement.
- Support product recalls and stock recoveries.
- Administer product technical complaints, including progressing their investigation and report.
- Implement product and process change controls.
- Implement deviation investigations and CAPA's.
- Compile periodic product quality review reports in conjunction with contract manufacturers.
- Compile data for reports and presentations.
- Maintain currency of European GMP and GDP requirements.
- Implement changes that arise from either the introduction of new or revised GMP and GDP regulations.
- Liaise with the client's contract manufacturers and suppliers as required.
- Liaise with the clients group companies in areas of quality compliance as required.
- A degree level qualification, ideally in the life sciences.
- Must have worked in a QA role in a Pharmaceutical GMP/ GDP setting.
- Experienced in CAPA, OOs, OOt, and QMS management and implementation
- MHRA hosting/ liaison experience
- An awareness of European GMP and GDP legislation.
- Proven organisational and project management skills.
- IT skills, particularly in relation to using databases and familiarity with commercial software.
- Strong interpersonal skills, being able to communicate with senior stakeholders and 3rd party companies/ clients (globally).
- Being able to work independently.