GxP QA Compliance & Audit Specialist

Piramal Pharma Ltd; Grangemouth; On-site; GBP 42,000 - 56,000; Full time

Job summary

Piramal Pharma Solutions in Grangemouth seeks a QA Compliance Officer to support governance of the Pharmaceutical Quality Management System and maintenance of regulatory registrations. You will work with site functions to ensure compliance with UK/EU/US GMP and ICH guidelines, driving quality improvements and coordinating with stakeholders.

The role emphasizes QA system monitoring, supplier audits, and regulatory preparation, requiring GMP experience and a certified auditor mindset.

Qualifications

• 2+ years' experience within Quality Assurance working to GMP.
• Experience performing self-inspections or audits of 3rd party suppliers (GMP material manufacturing/testing laboratories, API or Drug Product manufacturing facilities).
• Experience of working within a Quality Management System (SOPs/Deviations/Investigations/CAPA).
• Certified Auditor Training.
• Experience in supplier/vendor/material approval activities.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Support key quality system elements, including QMS monitoring and audits.
• Support updates to regulatory agency registrations as applicable.
• Track site compliance commitments and follow-up actions.
• Collaborate with site functions to drive down out-of-compliance events.
• Support regulatory findings and evolving inspection focus.
• Review procedures and QMS documentation per internal and regional guidelines.
• Lead Quality Management Review meetings and track actions.
• Support CAPA development to resolve product, audit and customer issues.
• Assist pre-audit preparation and post-audit follow-up.
• Escalate significant quality or regulatory breaches to Quality Management.
• Maintain productive relationships with site personnel and stakeholders.

Skills

Attention to detail

Problem solving

Excellent communication

MS Office

Education

Related scientific/engineering degree

Tools

MS Office

Job description

Piramal Pharma Solutions in Grangemouth seeks a QA Compliance Officer to support governance of the Pharmaceutical Quality Management System and maintenance of regulatory registrations. You will work with site functions to ensure compliance with UK/EU/US GMP and ICH guidelines, driving quality improvements and coordinating with stakeholders.

The role emphasizes QA system monitoring, supplier audits, and regulatory preparation, requiring GMP experience and a certified auditor mindset.