- Leading Pharma group
- Experience in injectables, vaccines or Oncology products mandatory
Our client is a leading pharma group
You will be responsible of the following tasks:
- Supervise the implementation of the Quality Control function plans, and ensure their compliance with client quality system
- Develop the quality control function's work plan; assign work activities, projects and programs, review and evaluate analytical methods and procedures, and directing the quality control activities to serve the QC department objectives.
- Ensure that qualification/validation and maintenance of the QC Laboratory premises and equipment/instruments are appropriately performed
- Develop and maintain quality control procedures by ensuring completion of all tests, studies, reports and investigations in an accurate, effective and timely manner
- Review and evaluate all data generated according to written procedures and recommend on the release or reject of the analyzed items (raw materials, packaging materials, intermediate, bulk and finished products)
- Contribute for evaluation and qualification of vendors of raw materials and packaging materials.
- Inform all involved functions of any rejects and non-conforming results related to raw materials, packaging materials, finished products, and any other area monitored by QC testing
- Lead the execution of investigations on relevant QC issues (OOS/OOT/deviations),verification results and determine corrective and preventive actions as per defined SOPs
- Develop and validate the analytical methods in accordance with the current regulations and apply the latest technical methods
- Validate the analytical test procedures, specification sheets, SOPs (pharmacopoeia and In-house). Review and approve documents related to QC function activities (procedures, protocols, reports, etc.)
- Establish and maintain a tracking and trending system of QC issues (OOS /OOT)
- Conduct performance appraisals for subordinates according to scheduled plan
📌 QUALITY CONTROL MANAGER ONCOLOGY (España)
🏢 Michael Page
📍 España
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