LE Quality Validation Eng II
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2019.
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Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
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LE Quality Validation Eng IIApply Now
- Review/approval of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ) to ensure compliance to procedures and regulatory requirements.
- Review and approve test incident occurred during the validation in a quality perspective
- Participate and approve the risk analysis linked to validation activities in a quality perspective.
- Review/approval of periodic review of critical system to ensure compliance to procedures and regulatory requirements.
- Collaboration and participations in projects as Quality Representative for Validation. Provide quality guidance for the development of the validation approach. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
- Take part in internal and external audits.
- Affinity/Experience with Computerized Systems Validation (CSV) and Data Integrity, as well as Process or Equipment Validation.
- Skills : Computerized System minded.
Notice to Employment / Recruitment Agents:
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 SR0037086