GMP QA Compliance Lead for Regulatory Readiness

Piramal Pharma Limited; Grangemouth; On-site; GBP 32,000 - 52,000; Full time

Job summary

Piramal Pharma Solutions at the Grangemouth site is seeking a QA Compliance Officer to support governance of the Pharmaceutical Quality Management System and maintain regulatory registrations, licenses and certifications. You will ensure compliance with UK/EU/US GMP/GDP and ICH guidelines, and work with stakeholders on quality improvements.

The role involves audits, CAPA, QMS documentation reviews and preparation for regulatory inspections, collaborating across site functions to uphold quality

Qualifications

• Experience in GMP QA and working within a Quality Management System (SOPs/Deviations/Investigations/CAPA).
• Experience with self-inspections or audits of suppliers/manufacturers or testing labs.
• Awareness of regulatory inspections and compliance.
• Certified Auditor training is a plus.

Responsibilities

• Support key quality system elements, including QMS monitoring and audits.
• Assist updates to regulatory registrations as applicable.
• Track site compliance commitments and actions.
• Work with site functions to reduce non-conformances and drive quality improvements.
• Support regulatory findings and trends related to inspections.
• Review procedures and QMS documentation per internal and UK/EU/US/ICH guidance.
• Lead Quality Management Review meetings and tracking actions.
• Support CAPA development and closure to resolve issues.
• Assist pre-audit preparation and post-audit follow-up with customers and regulators.
• Escalate significant quality or regulatory breaches to Quality Management.
• Maintain relationships with site personnel and stakeholders.

Skills

Attention to detail

Problem solving

Excellent communication

MS Office (PowerPoint Excel Word)

Education

Related scientific/business degree

Job description

Piramal Pharma Solutions at the Grangemouth site is seeking a QA Compliance Officer to support governance of the Pharmaceutical Quality Management System and maintain regulatory registrations, licenses and certifications. You will ensure compliance with UK/EU/US GMP/GDP and ICH guidelines, and work with stakeholders on quality improvements.

The role involves audits, CAPA, QMS documentation reviews and preparation for regulatory inspections, collaborating across site functions to uphold quality