Lavori attuali relativi a Pharmaceutical Operations Leader - Aprilia, Lazio - Catalent
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Pharmaceutical Operations Leader
2 mesi fa
Job Summary:
Catalent is seeking a highly skilled Quality Assurance Operations Manager to join our team. As a key member of our quality department, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- 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 Good Manufacturing Practices (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.
Requirements:
- Master degree in pharmaceutical studies or a related life-science field.
- At least 3 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.
What We Offer:
- A challenging and rewarding role in a global company.
- Potential for personal development within an international company.
- Defined career path with annual performance review and feedback process.
About Catalent:
Catalent is a leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. With over 80 years of experience, we have proven expertise in bringing customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply.
Join Our Team:
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by sending an email to.
