Summary: The Quality Assurance Officer role at Pharmaron's Cramlington site involves ensuring compliance with GMP standards in the manufacturing of Active Pharmaceutical Ingredients (API). The position focuses on maintaining the Quality Management System, conducting audits, and providing expert guidance on regulatory requirements. This role offers opportunities for career development in a dynamic and scientifically rigorous environment. The successful candidate will play a crucial part in upholding quality standards and supporting the company's commitment to scientific excellence.

Key Responsibilities:

• Provide expert guidance on GMP requirements, ensuring compliance across all relevant areas.
• Conduct meticulous batch documentation reviews and carry out batch disposition as delegated by the Head of Quality.
• Operate the Quality aspects of SAP to ensure batch disposition aligns with cGMP requirements.
• Support cGMP compliance during the design, cleaning, commissioning, validation, and API production processes.
• Oversee supplier qualification/requalification processes and execute audits as required.
• Conduct cGMP audits of the Cramlington facilities and ensure corrective actions are implemented.
• Ensure procedures within the Quality System remain valid and appropriate through planned reviews.
• Review and maintain compliance of process validation documentation and periodic quality reviews (PAR).
• Coordinate the QA aspects of the site’s stability programme in accordance with cGMP.
• Manage deviations, change controls, CAPAs, complaints, and internal audit processes.
• Provide quality review and sign-off for plant cleaning and facility validation documentation.
• Interact with Contract Manufacturing Partners to fulfil cGMP and Quality Agreement requirements.
• Contribute to project teams, ensuring QA aspects are completed according to plan.
• Stay informed of industry quality developments and share relevant insights with site teams.
• Provide training on Quality/GMP processes and support site trainers in quality standards.
• Assist in planning and executing regulatory inspections and customer audits, acting as a subject matter expert when required.
• Maintain personal training records and ensure compliance with departmental training requirements.
• Adhere to Health, Safety, and Environmental regulations, working in an organised and efficient manner.

Key Skills:

• Proven experience in successfully applying regulatory skills to resolve challenges in a GMP environment.
• Ability to effectively contribute to multi-disciplinary scientific teams.
• Strong organisational skills with the ability to prioritise tasks efficiently.
• Excellent attention to detail and a methodical approach to work.
• Strong written and oral communication skills.
• Effective problem-solving abilities.
• Good IT skills, particularly proficiency in Microsoft Word and Excel.
• Degree or equivalent qualification in chemistry or a related field (desirable).
• At least three years' experience in a compliance role within an industrial setting (desirable).
• Leadership skills with the ability to mentor and develop team members (desirable).

Salary (Rate): undetermined

City: Cramlington

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other