GMP Specialist
An international pharmaceutical company has opened a competition for the position of GMP Specialist
Responsibilities:
- Own interactions with Competent Authorities at all steps of EAEU GMP inspections, prepare application package, arrange translation, maintain arrangement of inspections and conduction of inspection directly at manufacturing sites or remotely;
- Monitor the changes in requirements and legislation in EAEU GMP inspection process;
- Closely work with manufacturing sites to ensure readiness of sites to requirements of EAEU GMP rules, in development of CAPA plan and follow-up on its execution;
- Coordinate inspection time-frames and facilitate the work of the inspectors and manufacturing site team during the inspection;
- To accomplish and ensure in-time management of GMP inspections in accordance with internal plan;
- To collaborate with Regulatory Affairs team if changes in the regulatory dossier are required to ensure correspondence with manufacturing documentation;
- To identify potential risks and gaps in the assigned projects and propose solutions to mitigate those;
- Accountable for providing the most accurate and up-dated information about GMP inspections in geography of responsibility in respond to any intra-company internal request;
- Deliver projects in time, whilst ensuring communication of status and requirements across multiple business functions, organize and hold regular calls and F2F meetings with involved function areas;
- Act a s a back-up of Quality manager for product quality related matters;
- To assure compliance with local regulation and Elanco standards;
- Support for Quality Manager with relation to QMS activities as per needs.
Requirements:
- Excellent organizational and implementation skills;
- Personal accountability and strong drive for execution;
- Good knowledge and understanding of EAEU GMP rules;
- English language - Upper-Intermediate.
Benefits:
- Competitive salary;
- Annual bonus;
- Medical and life insurance;
- Meal allowance;
- Corporate events;
- VHI for an employee, as well as for children under 18 years of age.