Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply.
For our Aprilia production site, we are looking for a QA Operations Leader.
The role: Verify that all product development and manufacturing operations have been documented clearly and exhaustively to ensure full traceability of each production batch;Ensure that the review of process documentation (batch record) occurs in compliance with what is provided for by GMP and Company Procedures;Manage site documentation in order to ensure full compliance with internal and regulatory requirements (cGMP, ISO 13485, ISO 22716, BRC, CRF 21 part 111, and the HACCP Manual).Ensure the correct management of investigations, deviations, returns, and complaints, root cause analysis, CAPA implementation.Actively participate in inspections carried out by health authorities, regulatory bodies, corporate assessors, or the quality units of clients.Execute the approval of cosmetic and nutritional product batches in the LIMS system;Perform the Annual Product Review of pharmaceutical and nutritional products where required, ensuring billing within the expected times.The candidate: Master degree in pharmaceutical studies or a related life-science field.At least 5 years of experience in a quality function within a quality department in the pharmaceutical or healthcare industry.Strong quantitative and qualitative assessment skills and critical thinking skills.Must possess and demonstrate knowledge and experience in GMPs.Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where 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.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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