O-1979 Quality Assurance Specialist – GDP/GMP

Quality Assurance Specialist – GDP/GMP

ADIENNE SA, a bio-pharmaceutical company based in Lugano, is looking for a Quality  Assurance Specialist with focus on the Company quality systems and the oversight of contract manufacturers’ quality & compliance.

Role and Responsibilities:

  • Contribution to the maintenance and continuous improvement of the company quality system, with focus on GDP
  • Carry out day-to-day activities in compliance with company procedures
  • Write and collaborate in drafting SOPs related to company quality system
  • Help ensuring that applicable documentation is complete and current to carry out GDP duties
  • Quality support for affiliates and distributors
  • Contact point for third party manufacturers regarding quality, GMP and GDP matters
  • Carry out batch record review for products manufactured at third party manufacturers
  • Collaborate to manage quality complaints, deviations and changes: maintenance of accurate records
  • Involvement in GMP and GDP audits to vendors
  • Collaborate to self-inspections and inspection readiness
  • Collect and analyse data for Product Quality Review document
  • Collaborate in GDP Management Review activities including GDP metric review

 

Job Requirements:

  • Bachelor degree in a relevant scientific discipline e.g. Pharmaceutical Science, Pharmacy, or related Biological Sciences is required
  • Previous experience (5 years at least) in the pharmaceutical industry, in a Quality Department
  • Knowledge of cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies.

 

Skills:

  • A highly motivated individual, with excellent time management skill
  • A very organised and methodical approach to tasks
  • IT skills – competent in using Microsoft Office
  • Proficiency in Italian and English (written and spoken)

 

Additional Requirements:

  • A level of flexibility is essential to meet varying workloads
  • Resident in Canton Ticino or in surrounding border areas
  • Team player

Please apply to: hr@adienne.com