Quality Assurance Operations Manager

1 settimana fa

Aprilia, Lazio, Italia Catalent Pharma Solutions A tempo pieno
Job Summary

Catalent Pharma Solutions is seeking a highly skilled QA Operations Leader to join our team. As a key member of our quality department, you will be responsible for ensuring the highest standards of quality and compliance in our operations.

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 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 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.
What We Offer
  • An exciting role with opportunities for growth and learning.
  • A chance to work in a global company with a defined career path.
  • Annual performance review and feedback process.
  • Rewarding opportunities for personal development.

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