QA Validation Lead

Walker Cole International is searching for a QA Validation Lead to join a growing Sterile Manufacturer. As the QA Validation Lead, you will be responsible for overseeing validation activities across the manufacturing site, ensuring compliance with GMP and regulatory standards.

As the QA Validation Lead you will be responsible for:

• Leading and managing the validation strategy for facilities, equipment, utilities, cleaning, and processes in accordance with GMP.

• Supporting cross-functional teams including Engineering, Manufacturing, and Quality Control to ensure robust validation lifecycle management.

• Ensuring compliance with regulatory requirements (MHRA, EMA, FDA) in relation to validation and qualification.

• Leading and preparing the site for regulatory inspections and audits related to validation activities.

• Developing and maintaining validation documentation including protocols, reports, and risk assessments.

The successful candidate for the QA Validation Lead must have:

• A degree in Life Sciences, Engineering, or a related discipline.

• Experience working on a CAPEX Project.

• Extensive experience in validation within the pharmaceutical manufacturing industry.

• A strong understanding of GMP and regulatory requirements for validation.

• Experience working in a QA function and interacting with regulatory bodies.

• Proven ability to lead and influence cross-functional teams in a matrix environment.

QA Validation Lead | Validation Manager | Quality Assurance | GMP | Pharmaceutical Manufacturing | Equipment Validation | Process Validation | Cleaning Validation | Facilities Qualification | Regulatory Compliance | Quality Assurance | Validation Lifecycle