Quality Assurance Operations Manager

1 mese fa

Aprilia, Lazio, Italia Catalent A tempo pieno
Quality Assurance Operations Leader

Catalent Pharma Solutions 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, Catalent has proven expertise in bringing customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply.

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 GMP and Company Procedures.
  • Manage site documentation 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 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.
Position Benefits:
  • An exciting role with opportunities for growth and learning new skills in a global company.
  • Potential for personal development within an international company.
  • Defined career path with annual performance review and feedback process.

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.

Personal initiative. Dynamic pace. Meaningful work.

Visit our website to explore career opportunities.

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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title, and location to. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

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