Description
- Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing and Supply requirements, develops stability data where gaps exist
- Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products'performance/stability profile
- Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
- Perform change control impact assessments and document the stability assessment in change controls
- Review and endorse change controls as an expanded reviewer and Initiate change controls related to stability operations
- Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups
- Leads work activities involving Change Controls and CAPA's
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
- Acts as an advisor and mentor to stability staff
- Support health authorities inspection internal and external
Profile
- Relevant work experience required, preferable in a Pharmaceutical environment B.S. Chemistry, Biology, Microbiology or relevant discipline
- Expert knowledge and understanding of stability ICH Guidelines and associated policies, directives and thorough knowledge of cGMP regulations
- Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices
- Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
- Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
- Excellent written and verbal communication skills
- Exhibit strong leadership and decision making skills
- Advanced knowledge in English and French
Job Offer
- A very renowned company
- Continuous support during the assignment
- Good infrastructure
- You will work in an international environment
Kontakt
Hays AG
004962117884297