QA validation expert (9 months)
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QA validation expert (9 months)Apply Now
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Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
QUALITY ASSURANCE VALIDATION EXPERT
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Assurance Validation (QAV) Expert position (9 months).
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Assurance Validation team within a world-class Biotech manufacturing environment.
About the Role
The objective of this position newly opened within the Quality organization is to provide support to the QA Validation in reaching its milestones in a very demanding period with a high volume of projects opened as well as the commitments related to audit observations and at the same time fulfilling their responsibilities on the routine activities. This role is to actively support the QA Validation team on reviewing validation deliverables (validation plan, protocols, reports, URS, design qualification, risk assessment...), supporting projects implementation and routine activities.
Essential duties and responsibilities
Working closely with the Validation, Engineering, Manufacturing, Automation, QA and QA Validation team members, the main responsibilities of the job holder are:
- Main quality partner of the validation team.
- Responsible for quality aspects during the validation activities.
- QA validation representative for both validation routine activities and projects.
- Ensure quality of information within validation documentation in respect to current regulations and internal procedures.
- Involved in the audit GMP as quality partner of the validation team.
- Responsible for reviewing and approving validation protocols, reports, procedures and other related documents related to cleaning, sterilization, equipment, process, HVAC, utilities, Computerized systems to ensure compliance to internal procedures and regulatory requirements.
- Review and approval of routine monitoring protocols (CIP, SIP, Temperature control unit)
- Define and challenge, with the validation team, validation approaches to be compliant with current regulations
- As the QA validation representative in projects: ensure the quality validation aspects are respected within project, raise the compliance gaps to the QA Validation manager
- Evaluate and approve deviations related to validation protocols in order to guarantee proper tracking/documentation of the incidents and identification of corrective actions.
- University degree in Bioscience / Engineering / Biotechnology
- At least 5 years of experience in quality biotechnology manufacturing and/or pharmaceutical industry, preferably both
- Experience in validation (CIP, SIP, HVAC, Process, utility, Computerized system)
- Fluent in French
- Professional English level is required as most of documents to review are in English
- Good knowledge of FDA, EMA, ICH regulations and Quality system standards.
- Ability to interact with all types of personalities in an effective and diplomatic manner.
- Critical thinking and demonstrated problem solving / root cause investigation skills
- Good analytical skills and ability to simplify the complex.
- Good organizational skills and continuous improvement mind.
- Autonomous, reactive and flexible
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 SR0037083