QA Validation Lead

Job Description – QA Validation Lead

Department: Quality Assurance – Technical

Job Level: Lead

Industry: Pharmaceutical Manufacturing

Reports To: QA Validation Lead / Head of QA

Job Purpose:

To lead and oversee validation activities within the pharmaceutical manufacturing site, ensuring that processes, equipment, systems, and facilities are validated in compliance with GMP, regulatory requirements, and company quality standards.

Key Responsibilities:

Lead and supervise validation activities, including process, cleaning, equipment, utilities, and computerized system validation as applicable.

Review and approve validation protocols, reports, risk assessments, and related documentation.

Ensure validation activities are properly planned, executed, documented, and completed within agreed timelines.

Ensure compliance with GMP, regulatory guidelines, and internal SOPs.

Coordinate with Production, Engineering, QC, R&D, and other relevant departments to ensure successful validation activities.

Lead investigations related to validation deviations, failures, and out-of-specification results, and ensure appropriate CAPA implementation.

Participate in the preparation and execution of validation plans and schedules.

Support regulatory inspections and provide required validation documentation and responses.

Monitor the validation status of equipment, processes, facilities, and systems and ensure timely revalidation where required.

Identify potential compliance gaps and recommend appropriate corrective actions.

Provide technical guidance and coaching to QA Validation team members.

Ensure proper archiving and maintenance of validation records and documentation.

Contribute to continuous improvement of validation processes and quality systems.

Qualifications:

Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Engineering, or a related field.

Relevant experience in QA Validation within the pharmaceutical industry.

Strong knowledge of GMP and pharmaceutical validation requirements.

Good understanding of validation principles, risk assessment, deviation management, and CAPA.

Good knowledge of regulatory requirements and guidelines related to validation.

Good command of English and Microsoft Office.