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Quality Assurance Specialist
Zentiva
Ankleshwar, IND
Full-time
Mid
Onsite
Discovered 3 weeks ago
Microsoft applicationsQuality Forward
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Key Skills for This Role
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QUALIFICATIONS & REQUIRED SKILLS
- University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
- Knowledge of pharmaceutical GxP regulations and Quality system
- · Strong understanding of GDP principles (EU GDP Guidelines) .
- · Experience in pharmaceutical quality systems or supply chain compliance.
- · Experience working in dynamic, transformational environments.
- · Ability to coordinate external service providers and internal stakeholders.
- · Strong documentation, organizational, and communication skills.
- Experience in transformation, working in a dynamic environment.
- Collaborative and team-oriented
- Very good communication skills, and a customer-oriented approach.
- Flexibility and ability to manage competing priorities.
- Sense of urgency, high autonomy & stress resistance, agile personality
- Proven hands-on attitude, be flexible and adaptable, open minded.
- Open minded, positive, and energetic person
- Good Microsoft applications knowledge and computer skills
- Advanced knowledge of English
KEY RESPONSIBILITIES AND ACTIVITIES
- Support maintenance of the Dutch WDA license in collaboration with the external RP service provider.
- Ensure all documentation required for WDA compliance is complete, current, and accessible.
- Coordinate internal inputs required for initial and ongoing WDA obligations.
- Maintain an overview of licensed activities and scope under the WDA
- Act as the primary internal contact for the external RP/WDA service provider.
- Ensure timely exchange of information between Zentiva and the RP.
- Coordinate review and routing of GDP‑relevant documents requiring RP approval.
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