Job Description:
We are seeking a Quality Assurance Professional to lead the validation process and ensure compliance with regulatory requirements. This role will oversee commissioning, qualification, and validation activities during facility start-up and transition to commercial operations.
Key Responsibilities:
* Provide QA oversight of validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.
* Review and approve validation documentation (URS, risk assessments, protocols, reports) to ensure compliance with SOPs and acceptance criteria.
* Ensure deviations, investigations, and change controls during validation activities are properly managed with QA oversight.
* Review SOPs related to qualification/validation activities.
* Support audits, regulatory inspections, and ensure validation readiness.
* Maintain compliance with EU/FDA cGMP, ISO, and industry standards (GAMP, ISPE, ASME, BPE).
* Coordinate QA validation activities to meet project timelines.
* Manage and support QA validation team performance, recruitment, and training.
Qualifications & Experience:
* Bachelor’s degree in Science or Engineering (e.g., Biochemistry, Chemistry, Engineering).
* Experience in QA/Validation in biologics, pharma, or medical device manufacturing (FDA/EU regulated).
* Strong knowledge of validation requirements in cGMP environments.
* Familiar with root cause analysis tools (Ishikawa, FMEA, 5 Whys).
* Strong planning, problem-solving, and critical thinking skills.
* Ability to work independently in a fast-paced, cross-functional environment.
Niche Skills (Preferred/Recommended):
* CQV Oversight – commissioning & qualification for start-up facilities.
* Validation Expertise – facilities, utilities, equipment, cleaning, computerized systems.
* Regulatory Knowledge – EU GMP Annex 15, FDA 21 CFR Part 11, ISO, GAMP 5.
* Quality Systems – deviations, CAPA, change control, audit readiness.
* Risk Management Tools – FMEA, Ishikawa, fault tree analysis.
* Technical Documentation – URS, validation master plans, IQ/OQ/PQ protocols.