- Our client is looking for a QA Validation Engineer to provide senior level support to the QA Validation function.
Core Duties and Responsibilities
- Provide quality oversight of facility and equipment commissioning and qualification activities.
- Provide technical assessments on management of change, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
- Provide quality oversight of engineering and validation studies, and review and approval of protocols and summary reports.
- Use project management skills to drive results and achieve expected timelines and outcomes.
- Represent the QA team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
- Support regulatory inspections and inspection readiness activities.
- Provide quality oversight and ensure GMP compliance for engineering and validation deliverables related to site projects (Compliance, Improvement, etc.) including requirements definition, specification, engineering design, qualification, cleaning and manufacturing process validation, and change management.
- Serve as point of contact for customer groups to identify project needs and ensure practices are consistent with quality and regulatory standards.
- Support site continuous improvement initiatives.
Minimum Qualifications and Experience:
- 5+ years of industry experience in a pharmaceutical GMP environment.
- BS in Engineering and / or Science and a minimum of 3 years of project support experience with increasing responsibility in the areas of Quality Assurance.
- Knowledge of FDA and EMA regulations and a working knowledge of statistical analysis and root cause analysis is required.
- Excellent interpersonal skills and strong oral and written communication.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
Please note, we do not require agency assistance with this role.