QP: GMP Batch Release & Quality Compliance Lead

Catalent; Bathgate; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Pension up to 7.5% matched

Life assurance

Private medical insurance

Generous holiday entitlement

Job summary

Catalent is seeking a Qualified Person to oversee GMP compliance and batch release at Bathgate, UK. You will certify products before release, resolve quality issues, and support regulatory compliance across Catalent sites.

This role emphasizes patient safety, product quality, and strong collaboration with internal teams. On-site work is required, with a focus on continuous improvement and regulatory excellence.

Qualifications

• Qualified Person in accordance with Directive 2001/20/EC and/or Directive 2001/83/EC.
• Bachelor of Science or equivalent in a relevant scientific discipline (e.g., Chemistry or Biology).
• Clinical trial experience is preferred.
• Experience in biotechnology is preferred.

Responsibilities

• Certify and release IMP and marketed product batches, ensuring GMP and regulatory requirements are met prior to distribution.
• Review and approve GMP documentation, including batch records, deviations, investigations, and other quality records.
• Ensure ongoing compliance with the Quality Management System and EU GMP regulations.
• Assess, approve, and support deviation, complaint, and quality investigation activities to ensure timely resolution.
• Collaborate with internal quality, technical, and operational teams to resolve batch release issues and drive compliance improvements.
• Review, approve, and release SOPs and other controlled quality documents.
• Act as the key quality contact for clients, manufacturing/testing sites, and other Catalent locations on batch release and regulatory matters.
• Participate in product recall activities, quality improvement initiatives, and cross-functional meetings to promote GMP compliance and safety.

Skills

GMP knowledge

Communication skills

Organisational skills

Interpersonal skills

Attention to detail

Decision making

Independence

Education

Bachelor of Science or equivalent (Chemistry/Biology)

Job description

Catalent is seeking a Qualified Person to oversee GMP compliance and batch release at Bathgate, UK. You will certify products before release, resolve quality issues, and support regulatory compliance across Catalent sites.

This role emphasizes patient safety, product quality, and strong collaboration with internal teams. On-site work is required, with a focus on continuous improvement and regulatory excellence.