Responsibilities for QA supervisor
• Train the Lab technicians in the different quality and reliability testing
• Coach the Lab Self-directed team
• Make sure the lab equipment’s and fixture are maintained in good conditions, following up the maintenance and calibration plans
• Develop and execute the annual requalification plan
• Interact with his PLT Lab partner worldwide working like a team to achieve the expected results
• Very good Interaction with the internal customers in NPD and Sustaining
• Measure the performance of the lab regarding critical KPI’s as
• Support external and internal regulatory and compliance audits and inspections
• Assist in the generation and authoring of product and process discrepancies (and associated investigations and dispositions), as documented via non¬conformance, deviation
• Ensure adequate support to all release system users (training, improvement, issues,…)
Qualifications for QA supervisor
• Able to perform functions in accordance with cGMP guidelines
• Individual may be required sit for extended periods
• Bachelor’s degree in a science discipline with 3 years’ experience in Pharmaceutical Quality or Manufacturing, or bachelor’s degree in non-science discipline with 6 years of Pharmaceutical Quality or Manufacturing experience
• Knowledge of aseptic manufacturing processes preferred
• Must wear appropriate PPE as required for various manufacturing areas
• Supports Plant Management with Technical changes such as new formulas, reformulation changes, packaging, equipment, and processes
• Develop and Issue line specification sheets with core weights, dimensions, coating, finished bar weights, visual aids, to Operations & Quality personnel
• Interacts with all Plant Departments, Suppliers, Corporate, governmental agencies, and external auditors
• Provides back-up to Quality Manager on all key functions
• Direct, coordinate and schedule the activities of QA personnel to proactively respond to plant production needs
• Develop and/or assist in developing quality programs and procedures as required
• Coordinate and maintain Master Control Documents, quality data collection, charting, trending, and reporting projects
• Assures efficient and accurate testing, reporting, and monitoring of product safety and quality
• Participation in corporate-driven projects, tests, reports, and data collection
• Anticipate and solve quality-related issues through evaluation of ingredients, materials, process, and finished products
Qualifications for QA supervisor
• Experience in development methodologies and types of testing (e.g., Functional, System Integration, Regression )
• Working knowledge in all construction disciplines
• Bachelor’s degree in a Scientific Discipline or equivalent related experience. Strong knowledge of GMPs and their application
• Strong statistical and mathematical aptitude
• Understanding of Statistical process control preferred
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