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QA operations specialist

About Us

GXP CONSULTING Switzerland is a company specialized in Life Sciences which provides high quality support to its customers all along the product lifecycle.

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QA operations specialist

QA operations specialist

Role and responsibilities

Review of batch records (API, raw materials, bulk, semi-finished and finished products).

Handles deviations, CAPA, and Change Control and ensures the execution and the follow up of escalation processes

Writes and assists with writing SOPs and further documents for QA.

Handles qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation), for QA review

Supports execution of qualifications and validations (FAT, SAT, DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation)

Handles the approval and qualification of suppliers, quality control laboratories, packaging services and packaging materials including participation to auditing and establishing Technical/Quality Agreements.

Handles the approval of GMP Material suppliers and ensures periodic evaluation of GMP Material Suppliers

Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner),

Support QC/QA transfers of new products/methods

Skills/Knowledge Required

Experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.

Master Degree (or equivalent) in Life Sciences or a related discipline.

Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

Solid understanding of solid oral dosage form manufacturing/packaging processes and QC testing methods.

Excellent written & oral communication skills.

Good interpersonal and training skills.

Languages: french and english (fluent)

 

GXP CONSULTING Switzerland is specialized in Life Sciences and provides high quality support and expertise to its customers through a full range of services all along the product lifecycle. Thanks to our extensive experiences, we offer pragmatic solutions in areas such as Quality Assurance, Regulatory Affairs, Operational Excellence, Engineering, Process Engineering, Manufacturing and Maintenance, Project Management, Human Factors/Usability and trainings... If you have exceptional technical skills, a great personality and you are passionate about serving others, then GXP CONSULTING Switzerland is the right place for you!

 

Qualified candidates must be legally eligible to work for any employer in Switzerland.

Please send your application to: p.debrabandere@gxp-cs.com

GXP Consulting Services

    Job Information

  • CompanyGXP CONSULTING Switzerland Sàrl
  • LocationLausanne, VD 1003
  • Job TypeVollzeit
    Festanstellung
  • Job CategoryVerschiedene Kategorien
  • Job-ReferenzcodeCH/06.02.2018
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Voie du chariot 3
1003 Lausanne
Switzerland
PO BOX 8009

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