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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
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: email@example.com