Quality Assurance Manager

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