GCP Quality Assurance Specialist

My client, a pharma company based in Scotland, seek a GCP Specialist to join their friendly team. Reporting to the Head of QA, this person will assist with all aspects of clinical compliance and quality management activities including document review, internal systems review and oversight of external site and vendor audits and follow up.

They will also review and assess quality metric trends e.g. from audits, to ensure that satisfactory CAPA plans are established. They will use their expertise to provide quality guidance to the company, ensuring that appropriate systems, processes and procedures are in place which comply with applicable regulations, and to study and company requirements.

This is an immediate employment opportunity and could be either full-time or part-time. The office is in Aberdeen, so location or relocation to Aberdeen is preferred, but this role can be remote, with fortnightly trips to the office (travel costs expensed).

Key Responsibilities:

• Assist in implementing and maintaining a comprehensive GCP compliant quality programme.
• Assist in setting the annual internal, vendor and project schedules.
• Oversee or conduct document audits, internal system audits, vendor audits and investigator site audits to assess compliance with study protocols and cGxP, and act as QA audit manager for selected audits.
• Oversee contract Auditors, providing first line of communication.
• Manage CAPA plans and follow up via an appropriate system and/or database.
• Oversee Quality Issue Management ensuring escalated issues are appropriately recorded, followed through to successful resolution and the outcomes reported.
• Assist the Head of QA to coordinate Competent Authority facility GCP inspections of the company and provide assistance for other GxP Inspections.
• Assist the Head of QA with the initiation, writing, review, approval, update and distribution of documents e.g. policies, SOPs and associated documents, to support the Company QMS.
• Maintain awareness and integrate current and new GxP regulations and requirements into company systems, processes and procedures.
• When requested by the Head of QA, assist with the review of vendor SOPs, to ensure consistency with regulatory and company requirements.
• Provide routine and ad-hoc consultancy to company employees on all QA, GxP and Quality Management issues.
• Prepare and conduct basic and focused GxP training, as requested by the Head of QA.
• Provide feedback and suggestions for process improvement to ensure process efficiency and effectiveness.
• Conduct all activities according to regulatory requirements, global guidelines and company policies and procedures.

Key Requirements:

• Degree in science, nursing or a life sciences degree or degree in Quality Management
• Considerable pharmaceutical or allied industry experience (8 years minimum), including direct quality assurance or regulatory compliance experience.
• Working knowledge of GCP/ICH, EMA and FDA regulations and guidelines and how these interface with other cGxPs
• Commitment and ability to handle high workloads and deadlines
• Knowledge of Drug Safety/Pharmacovigilance advantageous
• Experience in working in a company with marketed products and IMPs advantageous
• Regulatory inspection experience (hosting/participant/interviewee) advantageous.

Personal Skills:

• Team player with strong communication and negotiation skills
• Ability to prioritise workload and commitment to meeting deadlines
• Ability to make decisions, evaluate risks, propose innovative solutions, and define and execute action plans
• Ability to work independently in an office or remote environment.

My client offers a competitive salary, negotiable based on experience, excellent working conditions, and a fulfilling and rewarding career, with plenty of opportunities for further development.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.