QUALITY CONTROL MANAGER ONCOLOGY - ALGERIA (International)

Michael Page; España; Presencial; EUR 55.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Attractive package

Descripción de la vacante

Michael Page is seeking a senior Quality Control leader for a leading pharma group in Spain. You will supervise QC function plans, develop work plans, review analytical methods, and direct QC activities to ensure product quality and regulatory compliance.

The role requires overseeing qualification/validation of QC labs, maintaining SOPs, and leading investigations (OOS/OOT/deviations) with CAPA implementation. Attractive package and growth opportunities offered.

Formación

• Quality control leadership experience preferred.
• Knowledge of QC methods, SOPs and regulatory requirements.

Responsabilidades

• Supervise the implementation of QC function plans and ensure compliance with client quality system.
• Develop the QC function's work plan; assign activities and programs, review analytical methods and procedures, and direct QC activities.
• Ensure qualification/validation and maintenance of QC laboratory premises and equipment.
• Develop and maintain QC procedures; ensure timely completion of tests, studies, reports and investigations.
• Review data and recommend release or reject of materials and products.
• Contribute to vendor evaluation and qualification for raw and packaging materials.
• Inform involved functions of rejects and non-conforming results in QC testing.
• Lead investigations on QC issues (OOS/OOT/deviations) and determine CAPAs as per SOPs.
• Develop and validate analytical methods per regulations and apply latest methods.
• Validate test procedures, specifications, SOPs; review and approve QC documents.
• Maintain tracking/trending of QC issues (OOS/OOT).
• Conduct performance appraisals and coordinate technical audits of the QC Laboratory.

Conocimientos

Experience in injectables, vaccines or

Descripción del empleo

• 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 plans and recommend necessary actions as per the applied practices
• Co-ordinate technical audits of the QC Laboratory to determine the analytical quality systems are yielding the highest quality information and to ensure that the analytical instrumentation is functioning properly and calibration and servicing is as per schedule.

Attractive package