Local Quality Assurance Manager and Responsible Person (m/f/d)

The Angelini Group is a family-run company that employs around 6,000 people worldwide. In the pharmaceutical sector, Angelini carries out extensive research , development , production and marketing of active ingredients, drugs, medical products and nutritional supplements.

Angelini Pharma Österreich GmbH offers a constantly growing range of pharmaceutical products and is a leader in numerous therapeutic areas. To strengthen our team, we are now looking for a

LOCAL QUALITY ASSURANCE MANAGER and RESPONSIBLE PERSON (m/f/d)
Vienna, full-time

• Act as LQA Manager, operatively refer to:
  • Maintenance and continuous development of the quality system and local implementation of the global Angelini QMS as well as control of compliance with GMP/GDP/GVP guidelines
  • Contact person for local organization and the Angelini Global Quality for quality matters and for internal and external inspections/audits
  • Creation, adaptation and rollout of quality agreements, SOPs and work instructions (GMP/GDP/GVP)
  • Training System management covering quality GMP/GDP/GVP matters
  • Change, Complaints, Deviation and CAPA management
  • Local GDP Regulatory intelligence and quality alert monitoring
  • key performance indicators (KPIs) and collecting quality-related data for processes at local level
  • Qualification and oversight of local suppliers and local customers
  • Self-inspection and audit to Local supplier
  • Readiness management in case of Local HA/Partners/Global Quality inspected/audited
  • Local Quality Management review
• Act as Responsible person according to 10 AMBO 2009, operatively refer to:
  • Product release on the market
  • Quality issues management regarding and impacting internal warehouse processes and supply
  • Deciding on the final disposition of returned, rejected, recalled or falsified products
  • Approving any returns to saleable stock
  • Evaluation of customer complaints and non-conformities
  • Coordinating and promptly performing any recall operations for medicinal products
  • Quality related contact to local authorities
  • Supervise Risk Assessment
  • Host inspections performed by Local HA/Partners/Global Quality when Angelini Austria is inspected/audited

• University Education (degree in pharmacy, human, dental or veterinary medicine, chemistry, biology, or food and biotechnology in a contracting party of the EEA or in Switzerland)
• Comprehensive Experience in the pharmaceutical area (GMP/GDP) - 3 Years
• Previous experience in RP or RP deputy role is a plus
• Project management skills, knowledge of e-QMS (Trackwise) and DMS (Documentum) is an advantage
• Excellent written and spoken German and English skills
• Very good Microsoft Office, especially Excel knowledge
• Systematic, independent Working method, accuracy, reliability as well as ability to work in a team

In addition to an appreciative environment, we offer attractive working conditions in a modern company that encourages its employees to work independently and flexibly. For this position, we offer a monthly gross salary of at least € 3,500 with the willingness to pay a higher salary in line with the market depending on qualifications and experience. An extensive range of benefits rounds off the offer.

JBG81_AT