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Quality Assurance Validation Specialist
3 weeks ago
This is an exciting opportunity for a skilled quality assurance professional to join our team in the pharmaceutical industry.
As a Quality Assurance Validation Specialist, you will play a critical role in ensuring compliance with regulatory standards and maintaining a validated state across site operations. You will work collaboratively with cross-functional teams, including engineering, production, and quality, to support ongoing and project-based validation activities.
Key Responsibilities:
- Review and approve qualification and validation documentation (IQ/OQ/PQ) for equipment, systems, facilities, and utilities.
- Provide QA oversight during execution of qualification, requalification, and validation activities.
- Develop and maintain the Site Validation Master Plan (SVMP) in alignment with regulatory expectations and internal policies.
- Generate and execute project-specific validation plans and validation master plans.
- Coordinate with manufacturing and engineering teams to ensure timely and compliant completion of validation tasks.
- Lead or support investigations into deviations or deficiencies related to qualification activities, and drive corrective and preventive actions (CAPAs).
- Prepare and review SOPs, protocols, reports, and technical drawings related to validation.
- Review and approve calibration and preventive maintenance schedules and associated work orders.
- Conduct and support risk assessments, technical studies, and investigations impacting the validated state.
- Participate in audits and inspections, providing subject matter expertise on validation-related topics.
The ideal candidate will possess a degree in a scientific discipline and proven working years in a GMP-regulated pharmaceutical or biopharmaceutical environment. Strong knowledge of validation lifecycle principles, including IQ/OQ/PQ, and experience with Site Validation Master Plan development and maintenance are essential. Familiarity with regulatory requirements, excellent documentation, communication, and cross-functional collaboration skills are also required.
If you have a passion for quality assurance and a desire to work in a dynamic and fast-paced environment, we encourage you to apply.
Hobson Prior is seeking a highly skilled and motivated individual to join our life sciences recruitment team.
