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 :