Senior Quality Compliance Specialist
– Developing, and reviewing documentation in the quality system
– Performing internal training (as a trainer) of procedures/ instructions/ amendments system to quality documents and guidelines of the Pharmaceutical Quality System.
– Participation in the change control process, and opinion changes in the range of the Quality Compliance System.
– Performing and supervising internal audits at Davipharm and external audits at contractors’ production sites/ offices to ensure the quality system and quality of Davipharm products.
– Supervision the process of preparing and conducting qualifications for manufacturers/ suppliers/ service
– Supervision the process of preparing and conducting Quality Agreements with manufacturers/ suppliers/ service
– Implementation of system activities in accordance with the guidelines and quality risk management
– Participation in the deviation and corrective and preventive actions (CAPA) to ensure effective and timely implementation in accordance with the implemented procedure, including initiation of actions to prevent non-compliance.
– Participation in the investigation and supervision 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 and supervision of activities of return from customers, and recalls, ensuring their efficient and timely implementation in accordance with the implemented procedures.
– Implementation of designated projects for the development of the Pharmaceutical Quality System in Davipharm
– Other tasks by direct supervisor
– Master, Pharmacist, Engineer, bachelor of pharmacy
– At least 3 years of experience in the same position or works
– Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing processes, and validation.
– Good knowledge of the implementation of Pharmaceutical Quality systems.
– At least 2 years of experience in a pharmaceutical factory
– Ability to perform a risk assessment
– Ability to analyze and solve problems
– Understand the systematic process of WHO GMP, and EU GMP in the pharmaceutical industry.
– Excellent in MS Office: Microsoft Excel, Word
– Good command of English skills.
– Ability to work under high pressure and intensive deadlines
Please contact our Recruiter or apply via email firstname.lastname@example.org