Quality Assurance Manager
2 weeks ago
Catalent Inc is seeking a highly skilled QA Product Manager to join our team. As a QA Product Manager, you will be responsible for ensuring the quality and compliance of our products, from development to manufacturing.
Key Responsibilities:- Provide customer service with the highest integrity, focused on quality and compliance, with partnership with Catalent's customers and internal organizations.
- Review and approve all technical documents, including change controls, process improvement projects, product development projects, and preventive maintenance and calibration work orders.
- Coordinate functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
- Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems.
- Provide QA technical recommendations based on trend analysis to eliminate future problems.
- Participate in product development/validation/engineering project meetings to provide quality assurance input with respect to compliance to cGMP requirements.
- Provide feedback to the appropriate department regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines.
- Support internal, client, and regulatory audits.
- Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
- Bachelor's Degree in Science (Chemistry, Microbiology, or Biology preferred) with a minimum of five years of related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
- Prior experience working with validation, manufacturing, or product development preferred.
- Proven ability to multi-task and demonstrate diplomatic skills.
- Excellent English verbal and written communication skills.
- Intermediate to proficient skills in Microsoft Office applications.
- Prior quality assurance experience is required.
- Working knowledge of cGMPs and/or OSHA regulations required.
- Certified Quality Engineer is a plus.
Catalent is a global leader in the development and delivery of pharmaceuticals, biopharmaceuticals, and consumer health products. We offer a dynamic, fast-paced work environment and opportunities for career growth and development. Our employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
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