Quality Assurance Specialist 100%

Vor 2 Tagen

PlanlesOuates, Schweiz Stragen Vollzeit
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.
    • 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
  • 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

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 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

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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