Quality Operation Manager
Gi Group SAVery 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
APPLICATION
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- Gi Life Sciences
CONTACT
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