Role Overview
The QA Engineer will provide independent quality oversight for Commissioning, Qualification and Validation activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.
The role will work closely with Engineering, Validation, Manufacturing, Automation, Quality Control, vendors, and project teams to ensure that facilities, utilities, equipment, and associated systems are appropriately qualified, compliant, and suitable for their intended use.
Key Responsibilities
- Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for facilities, utilities, manufacturing equipment, laboratory equipment, and associated systems.
- Review and approve CQV deliverables, including:
- Validation plans and strategies
- User Requirement Specifications
- Quality and validation risk assessments
- Design Qualification documentation
- Commissioning plans and test records
- Installation, Operational, and Performance Qualification protocols
- Traceability matrices and turnover packages
- Qualification and validation summary reports
- Ensure CQV activities comply with approved procedures, GMP requirements, data-integrity principles, and predefined acceptance criteria.
- Review engineering drawings, P&IDs, equipment specifications, vendor documentation, calibration records, commissioning evidence, and system handover packages.
- Provide QA input during project design reviews, risk assessments, system classification, and validation-strategy discussions.
- Review qualification discrepancies, protocol exceptions, test failures, and deviations arising during CQV execution.
- Assess root-cause investigations, product and compliance impact, proposed corrective actions, and supporting evidence.
- Confirm that critical issues are appropriately resolved before equipment or systems are released for GMP use.
- Review and approve change controls, validation impact assessments, design changes, system modifications, and requalification requirements.
- Provide quality guidance to project teams during protocol development, field execution, troubleshooting, and documentation closure.
- Participate in project meetings and communicate quality risks, documentation gaps, and compliance requirements to relevant stakeholders.
- Monitor the progress and timely closure of validation deviations, change controls, CAPAs, and qualification deliverables.
- Support the final QA release and handover of qualified equipment and systems to operations.
- Provide QA oversight for periodic review, requalification, and continued validation activities where required.
- Support internal audits, regulatory inspections, and inspection-readiness activities involving CQV documentation and project systems.
- Promote risk-based, compliant, and efficient CQV practices across assigned projects.
Candidate Requirements
- Bachelor's degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.
- Relevant experience in Quality Assurance, commissioning, qualification, validation, engineering, or project quality within the pharmaceutical, biotechnology, or another GMP-regulated industry.
- Good understanding of the validation lifecycle and qualification principles for facilities, utilities, equipment, and associated systems.
- Familiarity with lifecycle documents such as URS, risk assessments, DQ, IQ, OQ, PQ, traceability matrices, protocols, deviations, and summary reports.
- Working knowledge of GMP, Good Documentation Practices, data integrity, deviation management, CAPA, change control, and quality risk management.
- Experience reviewing technical, engineering, qualification, or validation documentation.
- Able to interpret P&IDs, engineering drawings, equipment specifications, and vendor documentation.
- Experience with electronic validation or quality-management systems such as Kneat, ValGenesis, TrackWise, or equivalent platforms is preferred.
- Strong technical-review, investigation, problem-solving, documentation, and decision-making skills.
- Able to provide independent quality guidance while working effectively with multidisciplinary project teams and external vendors.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Functions
Skills
- Data Integrity
- Project Teams
- Internal Audits
- Laboratory Equipment
- Change Control
- Communication
- Readiness
- Documentation
- Biotechnology
