Davipharm

Job description

• Supervision of the process of developing, reviewing and approving documentation in quality system
• Implementation documentation of quality system
• Performing internal trainings of procedures system and guidelines of the Pharmaceutical Quality System
• Participation in the change control process, opinion changes in the range of the Quality Assurance System
• Supporting the senior quality assurance specialist in performing internal audits and Gemba walk at Davipharm and external audits at contractors to ensure the quality system and quality of products
• Realization and implementation of system activities (example: deviation, CAPA, change control, risk assessment) in accordance with the guidelines and quality risk management
• Coordination of corrective and preventive actions (CAPA) to ensure the effective and timely implementation in accordance with the implemented procedure, including initiation of actions to prevent non-compliance
• Implementation of the deviation process to ensure the effective and timely implementation in accordance with the implemented procedure, used the Problem Solving tools
• Participation in the investigation of complaints, ensuring their efficient and timely implementation in accordance with the implemented procedure. Assessment of the impact of the complaint on the product on the market
• Implementation of the quality projects for the development of the Pharmaceutical Quality System in Davipharm
• Participation in the periodic Product Quality Review, included trend analyzes and defining appropriate actions
• Implementation and monitoring of quality process improvement indicators and ensuring their implementation
• Do other ad-hoc assignments from direct supervisor
• Checking, labelling, prepare for releasing based on SOP

Job requirement

• Pharmcist, Engineer, bachelor, intermediate pharmacist
• At least 3 years of experience in QA department
• Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation.
• Excellent knowledge of the implementation of Pharmaceutical Quality system.
• 2-3 years of experience in pharmaceutical factory (operational area).
• Ability to analyze and solve problems.
• Ability to work under high pressure and intensive deadlines.
• Understand the systematic process of WHO GMP, EU GMP in the pharmaceutical industry.
• MS Office 365: Microsoft Excel, Word, Auto cad
• Good command of English skills.

Please contact our Recruiter or apply via email recruitment@davipharm.info