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

Berufsbezeichnung:

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

Unternehmen

Angelini Pharma

Stellenbeschreibung

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 aLOCAL QUALITY ASSURANCE MANAGER and RESPONSIBLE PERSON (m/f/d)
Vienna, full-timeIhre Aufgaben

• 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

Ihr Profil

• 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

Wir bietenIn 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.

Erwartetes Gehalt

Standort

Wien

Jobdatum

Sat, 18 Jan 2025 08:11:38 GMT

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