Quality Engineer
2 weeks ago
Job Description
Main Purpose of the Position:
Directly support Tank Management and Warehouse by acting as a key QA contact for issue resolution, discrepancy management, and documentation review.
Solve routine quality issues limited in scope and complexity following all applicable regulations.
Perform assigned tasks and work to achieve company goals and department objectives.
Provide technical review and approve validation deliverables ensuring proper study design and execution.
Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
Working with multiple functions, lead solution of validation issues following cGMP regulations and Genentech standards.
Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design and regulatory requirements.
Provide Quality Assurance oversight to Validation, Revalidation and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.
Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
Provide technical review and approve validation deliverables ensuring proper study design and execution.
Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
Qualifications / Requirements:
B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency and Genentech requirements.
Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), preferred.
Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
Basic knowledge of EU and US CGMPs and applicable validation guidance.
Ability to make sound decisions about quality and technical subjects.
Ability to communicate clearly and professionally both in writing and verbally.
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