Research Intern at IMPACT Initiatives in Geneva focusing on quantitative research and humanitarian action. Supporting research quality assurance standards and learning initiatives for crisis contexts.
About the role
- Quality Assurance Leader driving compliance with health regulations and quality management systems in a pharmaceutical setting. Requires a Doctorate in Pharmacy and significant quality assurance experience.
Responsibilities
- Recommends, implements and maintains a quality management system tailored to the company's needs and the regulatory status of the site's activities.
- Implements this system to meet applicable regulatory requirements for the site (GLP, GCP, GMP, GDP, ISO and other relevant standards).
- Defines and implements quality actions appropriate to the site's various activities.
- Sets standards for the quality training program to ensure implementation of the quality strategy and policies.
- On delegation from the Responsible Pharmacist, accepts raw materials, packaging and commercial products (cosmetics, pharmaceutical intermediates, medical devices, medicines).
- Ensures site readiness for regulatory inspections and customer audits.
- Manages a process- and risk-based approach to auditing the site, its subcontractors and its suppliers.
- Ensures that the product batch record review process is appropriate.
- Defines and manages the archiving and records management strategy.
- Releases technical batches and investigational batches of cosmetics and medical devices.
- Approves the GxP qualification/validation plan for facilities, equipment and systems.
Requirements
- Holder of a Doctorate in Pharmacy and a Master's degree in Quality Assurance or an equivalent qualification
- At least 7 years' experience managing internal and external audits
- Proficiency in GLP, GMP, GCP and GDP standards
Benefits
- Professional experience required
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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