QA Specialist

vor 2 Wochen

Visp, Schweiz Coopers Group AG Vollzeit
QA Specialist (m/f/d)

Location: Visp

Contract duration:

Responsibilities:

  • Act as QA representative in Project teams and represent QA in meetings
  • Act as QA contact for specific topics and realize the interface for DRs and CRs
  • Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
  • Support and approve risk assessments or regulatory specific risk or gap assessments.
  • Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
  • Represent Drug Product QA topics during regulatory inspections.
  • Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
  • Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
  • Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.

Requirements:

  • University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
  • Long-term experience working in the GMP environment of the pharmaceutical industry
  • Experience working in a QA department Drug Product
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