Very good opportunity for our partner in the pharmaceutical field as Quality Operation Manager.
QUALITY OPERATION MANAGER - Temporary position
Tasks :
- Draft, compile and maintain the necessary documentation for the provision of products to the CMOs.
- Review CMO disposition documentation, recommend release and escalate potential issues.
- Ensure the archiving and maintenance of batch files related to CMO materials and products.
- Enter information related to deviations, complaints, changes and product destructions in internal systems.
- Contribute to the preparation and review of Quality Agreements with external manufacturers and laboratories.
- Manage and communicate quality indicators related to the performance of CMO.
- Prepare and review Product Quality Reviews for the company's products, as required.
- Collaborate with CMOs and project teams to ensure readiness for inspections and regulatory filings during transfers or major modifications.
- Participate in the revision of protocols and analytical/methodological reports.
- Support quality activities related to the marketing of new products transferred or launched via CMOs.
- Provide quality support during self-inspections, internal audits and regulatory inspections at contract manufacturers.
- Support the supplier, global procurement, supply chain and manufacturing science teams for technical transfers, supplier selection and commercial production.
- Review validation documentation, deviations and changes, and report non-compliance risks.
- Escalate critical issues to management to ensure compliance and business continuity.
Profile :
- Minimum BS degree in a relevant scientific discipline
- Minimum of four 5 years experience in pharmaceutical operations on the manufacturing site and 2 years in quality, ideally in product release or pharmaceutical project quality
- Experience in manufacturing aseptic, sterile and biological pharmaceuticals
- Experience in technical writing, related to quality
- Ability to negotiate and present complex topics clearly both in writing and orally
- Knowledge of combination product manufacturing or finished pharmaceutical packaging
- Experience with testing methods of organic products / quality control
- Experience with standard GMP tools and applications
Gi Life Sciences Contact :
j4id10095183a j4it0311a j4iy26a