Quality Compliance Specialist

Highly Competitive
  1. Permanent
  2. Good Distribution Practice (GDP)
  3. Switzerland
Solothurn, Switzerland
Posting date: 07 Oct 2020

A fantastic opportunity has arisen for a Compliance Specialist in Solothurn. This position will partner with Compliance leaders from the EU region to ensure overall compliance through internal audit process.

Job Responsibilities

  • Conduct and lead Internal Audit as per company Internal Audit schedule and assess compliance with local, national, international and company regulations, policies and procedures
  • Support inspection readiness plan within EU region against EU MDR in high collaboration with site compliance partners and business partners.
  • Collect metrics data from sites.
  • Use of tracking and trending tools in order to share proactive trends/signal to the compliance leader.
  • Support Compliance improvements, which result from audits, Quality Board Issues and other system indicators
  • Work effectively with the Source Compliance team and other site compliance specialist to ensure consistent systems across the organization.
  • Ensure proper internal audit reporting, response review and approvals, communication of issues.
  • When required assist given facilities for both external audit preparation and assistance during their external audit

Skills and Requirements

  • Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485/EU MDR) within a regulated environment
  • At least 5 years working experience in a regulated Medical Device industry
  • Experience in a quality and/or compliance function as well as leading performing audits is required
  • Excellent Communication Skills (written & oral) in English - German would be a plus

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.