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Quality Assurance Specialist 100%
StragenPlan-les-Ouates, Geneva, SwitzerlandVor 30+ Tagen
StellenbeschreibungReview 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 Represents 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. Works 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 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 establish collaborative relationships Able to demonstrate independence, objectivity and ethics Able to apply good judgement and good appreciation of quality issues Able to work under pressure Attentive to details Fluent in English, both written and spoken Knowledge of quality management standards / regulations Scientific background Solid knowledge of GMP and GDP 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
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 of 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.
Personal core competencies
Skills
Qualifications / Prerequisites