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Pharma Scientist, Quality Control

Entreprise
Celgene Corporation
Lieu
Neuchâtel
Date de publication
06.03.2017
Référence
281569

Description

Pharma Scientist, Quality Control


Description

Celgene International Headquarters are located in Boudry (NE) and an additional manufacturing plant is being built in Couvet (NE) to support our growth. This site will primarily be dedicated to the manufacturing of solid dosage form products for patients in worldwide markets.

This position is responsible for managing QC-Methods validation projects. A key member of Quality Control Laboratory team, this position will regularly work cross functionally with other Celgene QC, MTS, ATS, PAT, REG, CMC, QA, IT, Drug Product Development and Vendors.

Duties and Responsibilities

  • Subject Matter Expert, SME, for QC-Methods Validation, laboratory Instruments & Software, data integrity and LIMS.
  • Ensure compendia, non-compendia, and cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
  • Author and when required review validation documents, including QC-Method transfer, QC-methods verification, validation plans, protocols, reports, summary reports.
  • Manage & execute PQ methods validation.
  • Participate to the development and maintenance of the local site procedures.
  • Participate to risk assessments & risk management teams.
  • Is the change control leader for the QC department for methods review or implementation, review and approve control documents, to evaluate impact on qualified systems and validated processes?
  • Manage validation projects; including managing time, resources and budgets; own associated change controls.
  • Develop and justify the validation approach based on risk and a scientific rational.
  • Co-ordinate qualification and validation execution activities, including external vendors and internal departments
  • Maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements.
  • Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing Methods validations/verification with auditors, and providing documentation.
  • Establish and maintain effective relationships with internal team, customers and suppliers.

Qualifications
  • BS degree in Life Sciences, Chemistry, Engineering or equivalent;
  • Minimum 5 years' experience in QC-methods validation;
  • Minimum 2 years' experience in managing QC-Methods validation projects;
  • Familiarity with current international regulatory regulations, cGxP requirements and best practices, including USP, Ph.Eur,, JP, 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP;
  • Experience in QC-Instruments purchasing & qualification
  • Good kknowledge of pharmaceutical facilities and laboratory systems;
  • Good communication skills in English with laboratory, technical operations, QA, and outside vendor groups;
  • Team player: ability to interact effectively with team and customers.


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