Computerized Systems Validation & Data Integrity Expert (12 months)
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Computerized Systems Validation & Data Integrity Expert (12 months)Apply Now
The objective of this position opened within the Quality organization is to provide expertise within the frame of the computerized systems validation and data integrity related projects for the products being produced entirely or partially in the Neuchâtel facility. The job holder supports the site within aforementioned projects in respecting the regulatory and compliance environment towards company requirements and international regulations & guidelines from a Quality perspective.
Working closely with the respective projects’ teams, the main responsibilities of the job holder are:
Computerized Systems Validation (CSV):
- Represent Quality Validation as the point of contact for CSV
- Define validation approach with regards to GAMP V and current regulations
- Support the CS/AS validation activities by defining the test strategy and the review process
- Participate in meetings related to changes/events impacting CS/AS systems
- Review and closure of the automation activities related to changes and events
- Support the Engineering Validation team on CS/AS issues
- Represent site Quality and Compliance as the point of contact for Data Integrity
- Act as site SME for Data Integrity requirements for all forms of recorded data media such as paper and electronic
- Support/Prepare documentation for changes, audit observations and regulatory agency questions
- Follow the status of regulatory commitment actions related to Data Integrity to their timely closure.
- Support/Write the responses to regulatory agency questions, and, if necessary, facilitate the collaboration among the relevant Subject Matter Experts to achieve the required documentation
- Prepare training materials and train the relevant employees on data integrity related regulations
- Lead the Quality organization to improve application of Data Integrity concepts into routine oversight activities.
Skills & Knowledge Required
Education & Experience:
- University degree in Engineering or Technical discipline
- At least 5 years of experience with CSV manufacturing in the biotechnology and/or pharmaceutical industry, preferably both
- Experience with the regulatory affair framework (CMC)
- Fluent in English, French is plus
Knowledge Skills & Abilities:
- Good knowledge of FDA, EMA, ICH regulations and Quality system standards:
- GAMP V
- 21 CFR Part 11
- FDA guidance on Data Integrity and Compliance with Drug CGMP
- Good Documentation and Data Practices
- Experience as a change owner or project leader
- Knowledgeable in inspection against regulatory / Quality standards
- Knowledge/Experience with Quality tools such as TrackWise system
- Good analytical skills and ability to simplify the complex
- Solution oriented
- Good listener and communication skills
- 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 SR0033249