Overview
Quality Assurance Specialist Jobs in Plan-les-Ouates, Genève, Switzerland at TN Switzerland
Position: Quality Assurance Specialist 100%
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Quality Assurance
Specialist 100%, Plan-les-Ouates Client:
Location:
Job Category:
Other
Job Reference:
54b
Job Views:
2
Posted:
18.04.2025
Expiry Date:
02.06.2025
Job Description:
The QA Specialist is responsible for the quality oversight for the API/IP supply and manufacturing of products for the customers under his responsibilities.
Accountabilities
Ensure qualification of corporate suppliers and subcontractors (API/IP suppliers, Contract Manufacturers, service providers, etc.)
Performance of audits
Establishment of Quality and technical agreements (writing and implementation)
Execute quality risk assessment process in a timely manner
Ensure adherence of suppliers and contract manufacturers to corporate policies/procedures, regulatory MAs, applicable Quality and Technical agreements and applicable US and EU regulations such as those of Pharmaceuticals, Food Supplements and medical devices.
Provide quality oversight of day-to-day operations performed at API/IP suppliers and Contract Manufacturers organization (CMO).
Review and approval of GMP documentation (CMO Master Batch Records, CMO process validation protocols and reports, CMO stability studies protocols and reports, etc.).
Review of CMO batch documentation for Stragen or customer release.
Review and approval of change requests.
Review and approval of PQRs.
Management of deviations:
Perform and document investigations according to internal procedures.
Management of complaints:
Perform and document investigations according to internal procedures.
Management of CAPA:
Establish and implement corrective and preventive actions according to internal procedures.
Management of product changeover:
Perform, document and coordinate the implementation of change controls.
Management of Quality Risk Assessment: evaluate, control, communicate and review the risk according to internal procedures.
Execute alert and batch recall process.
Provide status reports, including relevant metrics, to HOD QA Operations; actively contributing to QA Operations department and Stragen goals and objectives.
Represent and act as QA Operational in the Product Launch team.
Represent Stragen Quality Assurance including face-to-face visits, internal/external audits, and Quality Review Meetings.
Support Quality Operations in internal/external audits and regulatory inspections.
Provide support to customers for QA Operations topics.
Manage own time to carry out assigned duties that support business goals.
Work as a resource to identify process issues and execute implementation of CAPA in a timely manner to ensure customer commitments are met.
Perform all other duties assigned by the Head of Department / the management.
Personal core competencies
Creativity in problem-solving skills
Good negotiation skills with customer-oriented attitude
Excellent organizational skills
Able to prioritize, assess urgency and set deadlines
Able to manage multiple tasks simultaneously
Able to demonstrate independence, objectivity and ethics
Able to apply good judgement and good appreciation of quality issues
Able to work under pressure
Skills
Fluent in English, both written and spoken
Knowledge of quality management standards/regulations
Scientific background
Solid knowledge of GMP and GDP
Qualifications / Prerequisites
Scientific university degree
At least 5 years of experience in a Quality Assurance department of a pharmaceutical company
Experience working in close collaboration with customers & subcontractors
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Title: Quality Assurance Specialist
Company: TN Switzerland
Location: Plan-les-Ouates, Genève, Switzerland
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
