24 days ago on careers.peopleclick.com

Quality Operations batch review officer


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Quality Operations batch review officer

Quality Operations batch review officer
  • Requisition ID:143433
  • Position:Full time
  • Open date:28.09.2016 10:08
  • Functional area:Quality control
  • Location:Nyon
  • Required degrees:Not Indicated
  • Relocation:Not Indicated
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    Basic qualifications:

    Preferred qualifications:

    Quality Operations batch review officer

    AS a Quality Operations batch review officer based in our GSK Nyon site, you will ensure that Nyon Plant bulk, API HR batches and finish packed products are produced in compliance with GMP GSK Corporate requirements and both internal SOPs and regulatory approved documents.
    You will also make sure that Master Batch Records, Executed Manufacturing and Packaging Batch Records comply with registration documents and with GMP GSK Corporate requirements and internal SOPs

    Your responsibilities include in detail:

    •Ensuring that the GMP documentation ( MBRs, executed manufacturing and packaging records, raw data generated during manufacturing & packaging operations and API HR Operations) is reviewed and complies with GMP GSKCorporate requirements (Quality manual) and registration file.
    •Performing the review of manufacturing batch record, control and approve the documentation. Ensure completion, review and batch record compliance,  particularly electronic batch record, with GSK requirements
    •Following-up CAPA remediation plan implementation linked to Batch documentation review in API HR, bulk production areas associated with both internal and Health Authorities audit commitments and measure CAPA effectiveness
    •Ensuring that deviations linked with Batch Documentation Review are identified, fully investigated and ensure the follow-up remediation plan implementation (CAPA) in compliance with  Novartis quality requirements
    •Ensuring GMP documentation linked to Batch Documentation Review  is kept up to date :
    o SOPs, FRM
    o Master Batch Records
    •Archiving bulk batch documentation
    •Participating to immediate corrective actions and communicate on non-quality issue to concerned person.
    •Proposing improvements and modifications on procedure ongoing.
    •Opening deviation in case of issue during review.

    As a successful Quality Operations batch review officer, you have the ability to work in a fast moving environment, to handle pressure very well and always keep an excellent level communication within different level of stakeholders especially with the production department.  You are recognized for your autonomy, your organization and for being solution oriented.

    Furthermore you display the following qualifications and competencies:

    •CFC / Technicien in quality
    •Engineer or Pharmacist junior or technician with experience
    •3-5 years’ experience in a Pharmaceutical Production or Quality Environment.
    •Proven process understanding (Pharma, GMP, Bulk Manufacturing and Packaging Operations)
    •Continuous improvement experience (Lean, 5S, Problem Solving,)
    •Ability to demonstrate leadership
    •Safety, Quality, Result and Customer oriented
    •Trackwize and Excel are required for the role


    Contact information:
    You may apply for this position online by selecting the Apply now button.

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