Moscow
Full day
Any questions about this vacancy?
Send your question by email to hr@promomed.pro
And now we are looking for Senior Technologist/A leading technologist, capable of strengthening the team.
What are you going to do?:
1. Development of technological documentation
- Drafting and updating of Pilot industrial regulations (ERP), Standard operating procedures (SOP), work instructions (WI) and other regulatory documents
- Development of documentation in accordance with the requirements of GMP, GxP, Pharmacopoeia, ISO and other regulatory standards
- Preparation of specifications for raw materials, intermediates and finished products
2. Preparation of documents for registration and validation
- Preparation of Module 3 of the Registration Dossier
- Preparation of documentation on validation and qualification of production processes
3. Quality control and compliance with documentation
- Interaction with QA/QC and regulatory departments to ensure the correctness of documentation
- Accounting and archiving of documents in accordance with GMP requirements
4. Production process support
- Preparation of documents for technology transfer and scaling of processes to the production site
- Preparation of changes to documentation during the introduction of new technologies or modernization of production
- Participation in the investigation of nonconformities and preparation of relevant reports
5. Working with the regulatory framework
- Monitoring of changes in legislation and standards (GMP, FZ-61, ICH, USP, EP, etc.)
- Adapting internal documentation to meet new requirements
6. Interaction with departments and external organizations
- Coordination of work with the departments of production, quality control, engineering and R&D
- Preparation of documentation for audits (internal and inspection)
- Advising employees on documentation issues
7. Maintaining electronic document management systems
- Work in specialized systems (1C:Document management)
- Provision of electronic archiving and protection of confidential data
We expect from the candidate:
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Higher education (Pharmaceutical/chemical/biological)
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Work experience in a similar position for at least 2 years
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Experience in the development/manufacture of medicines
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Experience in production documentation preparation
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Experience in multitasking
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Knowledge of all drug lifecycle processes
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Verification and analysis of incoming technologies
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Ability to analyze and structure information
We offer:
- Office in the center, walking distance from M. Mira Avenue and Sukharevskaya metro station
- White salary: we will discuss the amount at the interview
- Opening hours: Mon-Fri, 9.00-18.00
- Ability to work remotely
- Extended VMI program with dentistry
- A large number of new and interesting projects
- Advanced training programs
- The corporate library
The main asset of the PROMOMED Group is its employees.
One of our values reflects the culture and atmosphere in the company, cooperation and development.
We value openness to new things, support those who want to learn, and we sincerely believe in what we do.
If you want to become a part of our team, please send us your RESUME indicating the level of salary requirements.
If you want to become part of our team, send your resume indicating your salary expectations
Any questions about this vacancy?
Send your question by email to hr@promomed.pro
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