QA Specialist

**QA Specialist - GMP - Pharmaceuticals**

**Livingston**

If you are keen to enhance your experience within an exciting global Scientific organisation offering a superb working environment, great training, benefits and careers, this could be the role for you

We are currently recruiting for experienced QA Specialists / Senior QA Specialists with a pharmaceutical / life sciences background.

The roles will be highly varied and you will assist in developing and maintaining a comprehensive quality management system to achieve inspection readiness for pharma products and other new products as required. Additionally, you will act as Quality Assurance support for the company’s distribution network.

**Your responsibilities will include**:
Developing, monitoring, improving and maintaining procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals together with performing activities and reviews in accordance with relevant Standard Operating Procedures, including but not limited to:

- Risk assessments
- Externally prepared documents
- CAPA
- Change requests
- Deviations (including Quality Investigations, EME’s and OOS)
- Complaints (customer / supplier)
- Development Studies / Reports
- QMS data logs
- Room release documentation
- Batch record review (including PPRs, PTRs, MPRs and SPRs)
- Fill / Finish documentation
- Product defect reporting and Quality Investigations
- Technical and Quality Agreements
- Validation
- Performing batch review duties in accordance with relevant procedures, including issuing Certificates of Non-Conformance for bulk drug product and review of QC batch test folders
- Identifying, investigating and reporting quality issues, escalating to management as required
- Participating in cross-functional projects
- Developing, implementing and monitoring Continuous Improvement activities
- Providing QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required
- Co-ordinating and providing training across functional groups in Quality Procedures, cGMP requirements and QA concepts
- Trend and report batch review and QMS data
- Providing support to management during third-party audits
- Performing internal housekeeping, in-process visits and quality audits
- Performing external quality audits, supporting Livingston and other sites
- Implementing and maintaining Quality Standard Operating Procedures, as required
- Training staff in QA related procedures and concepts as directed by line manager

**What experience will you need?**
- Educated to degree level in relevant qualification or relevant experience
- Proven and logical approach to problem solving
- Previous QA experience within a similar environment
- Experience of working effectively in a team, influencing as appropriate
- Experience of working within a GMP manufacturing environment
- Knowledge / experience of the requirements for distribution of pharmaceutical products

**The Benefits**

Status: Permanent
Rate: highly competitive salary & superb benefits package

Location: Livingston