QC Team Leader
|Employment Type:||Full Time|
|Location:||Ras Al Khaimah|
|No. Of Vacancies:||1|
Provide analysis and processing of bulk, finished products or Raw Material on time by appropriate methods while respecting Good Manufacturing Practices. Support resolution of technical issues in the laboratory. First contact in case of analytical issue in the laboratory.
Key responsibilities & Accountability:
• Management of a Lab Team (12-18 staff for laboratory testing)
• Release of commercial lots, testings for stability studies
• Follow-up of the quality system used in the laboratory, trend and reagents follow-up …
• Responsibility of the laboratory and the follow-up of the equipments
• Critical review of analytical data
• Knowledge of deviation process is an asset
• Be a support to reach objectives targeted such as planning adherence.
• Manage Laboratories, Deviations, Investigation & CAPA and the resolution of technical issues in the laboratory.
• Act as Lead Investigator, take in charge analytical projects
• Train other technicians to the QC analysis Escalates problems effectively to QC Managers
• Equipment SME
• Perform double check of analytical tests to ensure the integrity of results
• Create SOPs and working documentation needed for QC laboratories
• GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
• Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
• Maintains records and ensures proper documentation of the analysis and enter data on SAP.
• Ensure the quality of results provided by the department
• Quality documentation writing (deviations, CAPA, procedures, protocols, reports …).
• Transversal interactions with other teams in QC, with QA and different MPU: Guarantee good communication for transversal interactions.
• Must be a Graduate of Bachelor of Science in Chemistry or Chemical Engineering or Pharmacy.
• Minimum 10 years’ experience in a Pharmaceutical Environment (Finished ptoduct , preferable )
• Safety, Quality, Result and Customer oriented
• Basic speaker (A2) English level
• Strong Team spirit. Demonstrate exemplarity behaviours.
• Leadership skills
• Open minded and flexible
• Work under pressure
• Excellent interpersonal and intrapersonal skills.
• Proven process understanding (Pharma, GMP, investigation and method development)
• Continuous improvement experience (Lean, 5S, Problem Solving).