Durée indéterminée

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a

Senior Specialist QA Operations Projects

Vos tâches

Job Summary:

 

QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products.

This position is responsible for quality assurance (QA) involved primarily with the review and approval of documentation related to projects, mainly from Validation, Quality Control, Manufacturing, Maintenance, Metrology and IT departments.

As a Project team member, this position pro-actively collaborates to strategy definition and risk-based evaluation, to ensure Quality by design and cGMP compliance for Manufacturing /QC projects and systems transfer.

The Senior Specialist QA Operations Project is responsible for Quality oversight of computerized and automated systems according to current guidelines, global and local procedures and regulations. The Senior Specialist QA Operations Project is also responsible for enforcing Data Integrity principles and rules applied to computerized and automated systems at Couvet with support to other sites/locations as required.

The Senior Specialist, QA Operations Projects can be assigned special tasks in cross-functional projects like new product introduction and launches.

Additional tasks are risk assessments as well as the support of health authorities’ inspections and corporate audits.

This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, as well as to contribute to process improvement in his/her scope of activity.

This position will give support to partner departments for documentation re-engineering and review /approval of documents.

The Senior Specialist QA Operations Projects can act as the back-up of his peers or direct reports.

Essential Job Functions:

 

The position holder is responsible and accountable for the tasks given below. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to the position holder.

 

The position holder:

  • Responsible for Quality Oversight with follow up on deviations, investigations, CAPA handling, Change Management and Periodic Review related to computerized and automated systems as well as data integrity events. As a SME, this role supports or executes investigations, root cause analyses and CAPA definition as needed and appropriate.
  • Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution.
  • Participates on project leadership teams for the development and integration of business applications including but not limited LIMS, MES, SAP, OSI-PI. Provides clear communication to his manager on the overall compliance of the projects.
  • Responsible for leading, reviewing and approving data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements. Use and further develop Data Integrity checklists to assess all (laboratory or manufacturing) processes and systems.
  • Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site.
  • Supports the design of Master Batch Records for bulk or packaged commercial drug products.
  • Handles in cooperation with partners for GMP activities.
  • Provide collaborative support and Quality oversight regarding computerized and automated systems validation requirements.

 

 

 

  • Provides support and guidance to other departments and functions for Data Integrity topics.
  • Supports the internal GMP-audits process including the yearly internal audit plans, the writing of audits reports (paper or electronically) and the follow up and the implementation of the internal audit CAPAs.
  • Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner).

Votre profil

Job Requirements:

 

Experience / Education  

 

  • Minimum 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry, preferably with related computer systems validation and project management experience.
  • BSc/BA or MSc in Science or relevant discipline.
  • Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

Date d'entrée

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