Senior Quality Assurance Specialist

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.
– Performing internal trainings (as a trainer) of procedures/ instructions/ amendments system to quality documents and guidelines of the Pharmaceutical Quality System.
– Participation in the change control process, opinion changes in the range of the Quality Assurance System.
– Performing internal audits and Gemba walk at Davipharm and external audits at contractors to ensure the quality system and quality of products.
– Implementation of system activities (example: deviation, CAPA, change control, risk assesment) 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.
– Coordination and supervision over the 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.

Job requirement:

– Pharmcist, Engineer, bachelor, intermediate pharmacist.
– At least 3 years of experience in the same position.
– Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation.
– Knowledge of Pharmaceutical Quality system.
– Ability to perform risk assessment.
– 2-3 years of experience in pharmaceutical factory.
– 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.
– Meticulous, honest.
– Ability to interact with colleagues at all levels throughout the company.
– Support other departments at work.
– Good command of English skills.

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