Job Duties:

• Act 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 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.
• Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.
• Support the validation program during regulatory agency inspections. Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

Qualifications:

• 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 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.