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CQV Qualification + Documentation Management Lead
Ver: 152
Dia de atualização: 25-04-2024
Categoria: Administrativo / Escriturário / Assistente
Indústria: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing
Posição: Entry level
Tipo de empregos: Contract
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Conteúdo do emprego
Proclinical are recruiting a CQV Qualification + Documentation Management Lead for a pharmaceutical establishment. This role is on a contract basis and is located in Visp. The client is focused on permitting a healthier society.Responsibilities
- Handle COMOS / KNEAT / DMS interfaces for the CQV group.
- Manage System Boundary development surveillance.
- Plan qualification development, supervision and sanction which involves the release for IQ.
- Support the evaluation of project risk and analysing the efficiency of mitigation approaches implemented.
- Document crucial deliverables and dates and bring into line with crucial indicators within the projects critical path.
- You will handle qualification group approval (Qualifizierungsleiter).
- Guarantee reporting reliability across CQV group.
- Manage the CQV training program both directly and indirectly.
- The ideal candidate will prioritise and implement responsibilities in a fast-paced setting such as GQV Qualification and documentation management lead additional deliverables.
- Offer assistance to implement the design qualification for all immediate impact systems.
- If needed, will operate / assist other C&Q actions.
- Document and assist in providing project matter solutions.
- Execute and handle training procedures.
- Free to travel for business needs.
- Other duties may be assigned to the role.
- Educated to a degree level in s life science or engineering discipline.
- At least 6+ years of experience in commissioning / qualification / validation such as DQ, IQ, OQ, Commissioning actions in the pharmaceutical/biotech business.
- Knowledge in HVAC/Proven utility/process system, CIP, and SIP.
- Familiarity with DeltaV or Emerson.
- Fluency in the English language.
- Communication abilities both verbally and written.
- Know-how of regulatory needs as well as cGMP.
- Capable of operating under minimal supervision completing deliverables in objective timelines.
- Knowledge of the German language.
- Acquaintance with the clients Commissioning / Qualification Approach.
- Previous involvement with COMOS/KNEAT platforms.
- Knowledge of biopharmaceutical.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#QACompliance
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Data limite: 09-06-2024
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