MI&S - Analytical Method SME I
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MI&S - Analytical Method SME IApply Now
Assure GMP compliant and timely method implementation and method maintenance
- Plan and document method validation activities together with QC lab
- Manage activities to support key projects: e.g. assay transfers
- Create and review submission documents: e.g. consolidated validation reports, justification of Specification
- Assure implementation of assay controls and qualification of critical reagents
Identify, lead and drive improvements or remediation for analytical assays
- Support new method development
- Conduct trendings (e.g. Control trending)
- Support or lead analytical assay investigations or problems solving (OOS, CAPA, invalids, etc)
- Drive assays improvement
Support audits: assure inspection readiness, act as SME if required (e.g. presentation of SOP, DP or validation documents …) Change owner
- Plan and document change requests related to analytical methods
- Implement change requests in a timely manner
- Work with Regulatory Department (RA), Product Quality Lead (PQL) and Chemical Manufacturing Control (CMC) Leads for submissions
- Within the frame of changes submission, provide answers to MoH authorities
Local SME for QC related divisional procedures: support Global QC initiatives Back-up of QC MI&S site Lead
Master’s degree in science (Biological, Chemical, Biochemical, …) or equivalent with minimum 3 years of experience in a similar function. Experienced with analytical methods and method validation, preferentially within a GMP QC laboratory
- Experience with GMP/GDP requirements
- Knowledge in analytical methods (Biology, microbiology, immunology, serology)
- Knowledge in analytical method validation and critical reagent qualification
- Good statistical knowledge and experience with data analysis
- Knowledge about regulatory requirements concerning analytical methods
- Experience with problem solving tools
- Team player
- Strong communication and organizational skills
- Analytical thinking
- Problem solving skills
- Technical writing skills (in English)
- Fluent in French and English
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0050283