Expert Quality Manufacturing Science API & Raw Material - St Gallen
- Recruiter
- Vifor Pharma
- Location
- Cardiff
- Salary
- Competitive
- Posted
- 10 Aug 2022
- Closes
- 26 Aug 2022
- Sectors
- Manufacturing & Industrial
- Contract Type
- Permanent
- Hours
- Full Time
About You
At Vifor Pharma we are looking to establish a new organisational model to manage important Contract Manufacturing Organization (CMO) partnerships. In this context, we have an exciting opportunity as Expert Quality Manufacturing Science API & Raw Material in St. Gallen. In this role you will report into the Head of Quality Operations External API & Oral Products and you will be responsible for ensuring product knowledge within Vifor for providing best support for our CMOs and analytical service providers.
Main Accountabilities:
Ensure knowledge management for APIs, raw materials and packaging materials of Oral products together with CMOs/suppliers or external analytical service provider
Ensure manufacturing and analytical method expertise
Taking care of successful implementation of product knowledge into Q Operations Oral products
Manage stability studies for APIs (Plan, Report)
Manage on-going stability studies for APIs (Plan, Report)
Leading Problem solving, root cause analysis & continuous improvement activities with internal and external parties
Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, ...)
Support handling of relevant deviations and complaints acc. defined process
Quality Assurance representative and project team member in projects including CMOs for oral products, if applicable
Reporting of PQRs for APIs
Support KPI Management, provide reports, tracking KPIs for evaluation of performance of CMOs/suppliers
Providing oversight to product-related data
Support for regulatory submissions
Ensure internal and external stakeholders engagement and alignment, working cross functionally with various teams in the organisation
Ensure timely and functional communication
Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, ...)
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Requirements
Bachelor/Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
Experience in Quality Control, Manufacturing or Stability Management, API, excipients, packaging material
Very good troubleshooting, problem solving skills
Extended scientific knowledge
Experience in lean management tools and Operational Excellence
Understanding of GxP & other relevant regulations
Fluent German/English
Preferred Requirements
Working experience in different cultures
Working experience in Pharmaceutical/Analytical Development
Audit experience
An additional language (e.g. French) would be an asset
About Us
At Vifor Pharma we are looking to establish a new organisational model to manage important Contract Manufacturing Organization (CMO) partnerships. In this context, we have an exciting opportunity as Expert Quality Manufacturing Science API & Raw Material in St. Gallen. In this role you will report into the Head of Quality Operations External API & Oral Products and you will be responsible for ensuring product knowledge within Vifor for providing best support for our CMOs and analytical service providers.
Main Accountabilities:
Ensure knowledge management for APIs, raw materials and packaging materials of Oral products together with CMOs/suppliers or external analytical service provider
Ensure manufacturing and analytical method expertise
Taking care of successful implementation of product knowledge into Q Operations Oral products
Manage stability studies for APIs (Plan, Report)
Manage on-going stability studies for APIs (Plan, Report)
Leading Problem solving, root cause analysis & continuous improvement activities with internal and external parties
Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, ...)
Support handling of relevant deviations and complaints acc. defined process
Quality Assurance representative and project team member in projects including CMOs for oral products, if applicable
Reporting of PQRs for APIs
Support KPI Management, provide reports, tracking KPIs for evaluation of performance of CMOs/suppliers
Providing oversight to product-related data
Support for regulatory submissions
Ensure internal and external stakeholders engagement and alignment, working cross functionally with various teams in the organisation
Ensure timely and functional communication
Coordination and handling of relevant processes, change controls, deviations, implementations, validations and documents for CMOs/suppliers in cooperation with other Vifor departments (Supply Chain, Regulatory, ext. development, QP, ...)
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Requirements
Bachelor/Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
Experience in Quality Control, Manufacturing or Stability Management, API, excipients, packaging material
Very good troubleshooting, problem solving skills
Extended scientific knowledge
Experience in lean management tools and Operational Excellence
Understanding of GxP & other relevant regulations
Fluent German/English
Preferred Requirements
Working experience in different cultures
Working experience in Pharmaceutical/Analytical Development
Audit experience
An additional language (e.g. French) would be an asset
About Us