Специалист GMP

Key Responsibilities

· Control of GMP inspections timelines and schedule, adhere to the plan with regards as well to regulatory submissions in Russia and EAEU countries.

· Preparation of the applications and materials for GMP inspections to the Ministry of Industry and Trade and performing the routine communication with GILS and inspectors on the operational part.

· Communication with the manufacturing sites for the planning, preparation for the inspections. Participation in inspections.

· Communication with the sites and inspectors with regards to the CAPAs planning, performing and closure.

· Risk assessment activities where needed.

Cooperation / CollaborationInternal

· Local Regulatory and other stakeholders

· Manufacturing sites

· Global Regulatory Affairs

· Corporate QA

· Local QA

· Local Marketing / Medical Affairs, if needed

· Local legal

External

· Ministry of Industry and Trade

· GILS

· Other entities, where needed

Requirements:

· Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Biotechnology, Biology, Medicine or a related scientific discipline or other related field

· Background in Medicinal product manufacturing and/or distribution is highly desirable

· Preferably at least 2 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / Quality operations or other related activities

· Experience in Good Distribution Practices

· Knowledge in local laws and local regulations applicable to the operation

· Willingness and enthusiasm to learn new skills

· Time management skills, ability to prioritize and work in a busy work environment

· Excellent communication skills

· Ability to work within a team environment and with cross functional teams

· To demonstrated proactive, problem-solving mentality with strong analytical skills

· Upper-intermediate English level

We offer successful candidates:

• Place of work : м. Савеловская (1 -2 days a week) + home-office, total 20 hours a week
• Fixed-term employment contract
• Stable salary, payment of bonuses based on the results of work
• Corporate training programs and the opportunity to develop professional and personal competencies in various formats
• Institute of mentors - experienced employees who will help newcomers adapt faster
• Flexible schedule, ability to manage your work&life balance
• Accident Life Insurance 24/7
• COVID-19 Employee Care and Prevention Program
• Benefit Constructor – the possibility of using flexible benefits or VMI in the preferred proportion
• A laptop, a corporate mobile communication tariff (according to the company's policies)
• Annual salary review