QUALITY ASSURANCE SPECIALIST – GDP/GMP

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.
Job Category: Quality assurance
Job Type: Full Time
Job Location: Switzerland
Working Class: Employee
Seniority: more than 5 years

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