Senior QA & Validation Lead (GxP Systems)

PCI Pharma Services; Wales; On-site; GBP 40,000 - 55,000; Full time

Job summary

A global pharmaceutical service provider in the UK is seeking a Quality Systems Manager to maintain and improve its Pharmaceutical Quality System. The role involves managing validation projects, writing and reviewing technical documentation, and ensuring compliance with regulatory standards. Ideal candidates will have a relevant degree and experience within a regulated industry. This position offers an opportunity to make a significant impact on pharmaceutical quality and compliance.

Qualifications

• Experience generating, reviewing protocols, reports, or technical documentation.
• Good experience in a quality or technical role within a regulated industry.
• Working knowledge of EU/US regulatory requirements.

Responsibilities

• Manage validation projects according to priorities.
• Write, review, and approve validation documentation.
• Co-ordinate annual computerised system reviews.
• Support regulatory inspections and client audits.
• Provide QA and GMP training as needed.

Skills

GMP knowledge

Strong communication skills

Project coordination

Self-motivation

Subject Matter Expert

Ability to perform audits

Education

HND or degree in life sciences, engineering or IT

Job description

A global pharmaceutical service provider in the UK is seeking a Quality Systems Manager to maintain and improve its Pharmaceutical Quality System. The role involves managing validation projects, writing and reviewing technical documentation, and ensuring compliance with regulatory standards. Ideal candidates will have a relevant degree and experience within a regulated industry. This position offers an opportunity to make a significant impact on pharmaceutical quality and compliance.