• Contract
  • Valais
  • Recruiter: Karolina Frank

The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

QA Specialist

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Specialist for a 6-month contract (with possibility for extension) based in the Valais area, Switzerland.

Main 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.
  • 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.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • 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
  • English language skills are required, German language is an advantage

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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