Senior Quality Assurance Specialist
з/п не указана
The primary activities may include but are not limited to:
- Sampling procedure organization and execution (where applicable)
- Assist the maintenance of retention samples necessary for batch release process
- Ensure compliant handling of Samples for local batch release (e.g. transportation, storage and tracking)
- Collaboration with Federal Service for Health Supervision for execution of personal duties for Local Batch release process
- Collaboration with Commercial and State laboratories in terms of execution of necessary tests and obtaining of corresponding documentation
- Verification of CoA for imported batch of medicinal products
- Ensure the accuracy and quality of the records related to Local Batch Release process
- Organize and maintains system of storage, archiving and (where necessary) retrieval of necessary records relating to local batch release process
- Work with commercial standards and reagents necessary for testing handling
- Special tests organization (on exceptional cases)
- Lead in the coordination of any product recall related to local batch release process
- Lead in the management of routine deviations and complaints related to local batch release, and assist in the coordination of significant investigations including Fact Findings;
- Conduct routine analytical change requests and support process modification change controls
- Track and monitor operational and quality performance of the commercial and State laboratories
- Assures compliance with established MSD policies/procedures and complies with all applicable governmental regulations (GMP, GDP, local legislation, etc.)
- Assists or leads the development, and ongoing execution of the Quality Agreement with State and Commercial laboratories.
- Assists or leads coordination and communication on matters related to the cGMP/GDP status to ensure that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines.
- Ensures that all deviations related to MSD Products release are fully investigated with any assigned actions effectively implemented within the agreed time frame.
- In conjunction with other internal MSD departments, ensures ready for all new product introductions or transfers, closely collaborating with appropriate business and operations areas, both internal and external, to achieve MSD objectives.
- Manages compliance issues promptly and performs risk assessments on critical issues to prevent stock out situation in the market.
- Participates in EHS, Business Compliance, cGMP/GDP and all other compliance-related matters, where applicable.
- Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements
You will be expected to ensure up to date knowledge is maintained on relevant external regulations as well as internal requirements.
- University degree in a relevant science (preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent) education)
- experience and knowledge in the field of GMP/GDP and other applicable local legislation
- experience in sphere of quality confirmation/local certification
- Dept knowledge of local pharmacopeia articles, normative documentation, medicines state registration process.
At least 5 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP/GDP and regulatory requirements. Competent in scientific problem solving and risk analysis capabilities.
Strong compliance mind-set, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation. Demonstrates organizational skills, is proactive and self-motivated with ability to multi-task. Some level of contractual and financial awareness is preferred.
Proficiency in Russian and English.