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Senior Compliance Specialist
3 weeks ago
We are seeking a highly skilled and experienced individual to fill the role of Scientific Pharmacopeial Liaison. This position will involve working closely with cross-functional teams to ensure compliance with various pharmacopoeias.
The successful candidate will be responsible for identifying, defining, and leading change controls and/or proposed initiatives required to ensure compliance of our manufacturing and testing of drug products produced in multiple manufacturing plants around the world.
This role will require close collaboration across compendial global monitoring function, R&D scientists, and quality & chemistry personnel as well as liaison between us and global pharmacopeia.
Key Responsibilities- Work with Compendial Monitoring team members to identify updates from USP, BP, EP and Pharm Europa compendial websites relevant to our drug products.
- Perform gap analysis to define potential gaps created by updates for various Vantive products and manufacturing sites.
- Post-gap analysis, liaise with individual plants to define plan in context of change control if appropriate.
- Own technical execution plan for such changes, articulate step-by-step analytical chemistry method development and validation as needed, acting as an analytical lead.
- Collect feedback on any published pharmacopeia updates from all stakeholders and compile cohesive response.
- Prepare/redline product documentation and document change control package development.
- Monitor/track changes through TrackWise 8 system, follow up with change assessors.
- Upload completed documents into systems.
- Highly proficient in quality documentation systems.
- Previous hands-on experience in analytical chemistry labs in pharmaceutical setting required.
- Demonstrated experience working in global teams.
- Past experience of working with high daily dose liquid drug products (e.g., parenteral or IV drug products).
- Advanced proficiency in Word, Excel, Team Center for documentation, and TrackWise 8 software systems.
- Familiarity with technical matters in drug product space.
- Excellent verbal and written communication skills.
- Ability to work under tight deadlines amidst changing priorities with minimal supervision.
- Permanent contract with stable and secure work environment.
- Comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
- Collaborative and dynamic work environment.
- Access to state-of-the-art equipment and technology.
- Recognition and reward for outstanding performance.
Committed to reasonable accommodations to individuals with disabilities globally. If, due to medical condition or disability, you need accommodation for application/interview process, please let us know along with contact information.
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