£34000 - £36000/annum
Compliance Specialist - Quality Assurance
Location: Ware, Hertfordshire, UK
Working Hours: 8:30am - 5pm
Department: Quality Assurance
Are you passionate about pharmaceutical quality and compliance? Do you thrive in a fast-paced, regulated environment where attention to detail and continuous improvement are key? If so, we have an exciting opportunity for you to join our Synergy team as a Compliance Specialist supporting the Quality Control laboratories at GSK''s Ware site.
About the Role:
As a Compliance Specialist, you''ll play a vital role in ensuring that all aspects of quality control testing for medicinal products meet international regulatory standards and current Good Manufacturing Practice (GMP). You''ll work closely with the customer''s Lab Manager and Subject Matter Experts to maintain inspection readiness and drive excellence across lab compliance metrics.
Key Responsibilities:
Documentation Oversight: Coordinate updates and releases of lab documentation, ensuring audit readiness.
Pharmacopoeia Compliance: Monitor international pharmacopoeia changes and manage associated change controls and CAPAs.
Authoring & Reporting: Draft and update key quality documents and provide regular compliance status updates.
Process Coordination: Act as the go-to contact for compliance-related queries and manage training/access for Veeva Quality Document systems.
Monitoring & Audits: Support internal audits and perform monthly logbook reviews.
Deviation Management: Assist in resolving lab deviations and investigations.
Controlled Print Process: Oversee the accuracy and compliance of printed lab worksheets.
Training & Development: Own your training and support team compliance with training deadlines.
Team Engagement: Participate in compliance meetings and contribute to continuous improvement initiatives.
Experience and Qualifications
Relevant Bachelor of Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent, with minimum 3 years practical work experience.
Proficient knowledge of international Pharmacopoeias and recent changes
Experienced in managing analytical related change control and related CAPAs
Experienced in method qualification, development and validation.
authoring quality control related documents such as methods of analysis, protocols, reports, assessments, SOPs, laboratory worksheets.
Experienced in QC testing related to the testing of pharmaceutical products with different analytical techniques. Understands purpose of all techniques applicable to dosage form
Is competent in the application of statistical and mathematical tools and formulae and can derive formulae for analytical methods from first principles.
Is competent in the use of basic Lean Sigma tools, and can lead "JDl''s", and aware of the Quality Management System and 6 management principals
Proficient in using Microsoft Office Suite and corporate IT systems.
Key Behaviours and Competencies:
Accountability: taking ownership of own training and work and escalate any issues in real time
Autonomy: able to work autonomously, plan and manage own workload to consistently achieve output of high-quality and meet deadlines.
Integrity and transparency: complete all aspects of the role with integrity
Foster a positive team environment by sharing learnings, best practices, and feedback
Demonstrate attention to detail by identifying procedural or GMP errors and rectifying issues as needed.
Communicate effectively with stakeholders across departments, able to lead compliance meetings effectively ensuring meeting objectives are met. Confident in presenting detailed data to the team or wider quality community.
Resilience: able to maintain a positive approach in the face of challenges
Lead by example in all aspects of the role, including chairing local meetings to achieve outcomes and ensuring active participation from attendees.
Essential Experience:
Pharmacopoeia experience
Authored quality documents in GMP environments
Project management & multitasking
Not an analyst who had some exposure to documentation
Digitally fluent (MS package, Power BI, VQD, SAP)
Preferred
VQD knowledge
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
£35,000