QA Specialist

Bavarian Nordic A/S

Fuldtidsjob
Udlandet (øvrige)

To strengthen our Quality Management System and Quality Assurance Department in Martinsried/Munich we are searching for a qualified
Quality Assurance Specialist
Your tasks

  • Perform QA tasks, monitor and evaluate various aspects of Bavarian Nordic regulated studies and activities to ensure standards of quality are met in accordance with FDA, ICH, EMA and applicable regulatory requirements and guidelines pertaining to Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP)
  • Actively contribute to Bavarian Nordic’s quality system in close cooperation within the QA Department as the ell as Clinical Development and Pharmacovigilance team
  • Assist in maintaining and continuously improve the Quality Management System at Bavarian Nordic and increase awareness and knowledge of regulatory requirements in support of clinical research and post-market products
  • Create, review and maintain and track Standard Operating Procedures for compliance with GCP and GVP regulatory requirements, guidelines and industry standards
  • Write, review and/or track Deviation Reports, CAPAs, Change Controls and Investigation applicable to GCP and GVP areas. Participate in root cause analysis, impact assessment, corrective plan, follow up and trending
  • Support audits and regulatory inspections including planning, hosting, report preparation, and release, responses to audit findings, follow up on audit responses and assist in verifying CAPA effectiveness
  • Educate, train staff and coordinate training activities
  • Maintain Clinical QA trackers, folders and documentations up to date and organized to ensure inspection ready

Skills

  • Demonstrated knowledge of FDA, ICH, and EMA GCP and GVP regulatory requirements and guidelines.
  • Must possess a high level of personal integrity, excellent work ethics and respect for colleagues at all levels
  • Ability to work accurately with close attention to details
  • Work proactively and effectively in a fast-paced environment
  • Proven organizational skills and ability to handle multiple diverse projects simultaneously
  • Effective communication and negotiation skills, be able to work with matrix, internal team and external CROs, and be able to break down problems to find solutions

Your Profile

  • Minimum 2-3 years of work experience in the pharmaceutical or biotech industry, preferably in the area of Quality Assurance
  • Experience managing and tracking Key Quality Indicators and Quality Issues
  • In-dept knowledge of PV compliance would be an asset, especially post marketing
  • BA/BSc Degree in Pharmarcy, Biochemistry or any other related course of studies.
  • In-depth knowledge of Office standard applications (Word, Excel, PowerPoint)
  • Fluent in German and excellent command of English with strong written and oral skills

Your prospect

  • An exciting position within an international environment
  • Working in a highly motivated team
  • Broaden your experience in an internationally operating, biopharmaceutical company

Contact
If you are interested in the position, we look forward to receiving

your application in English with your earliest possible start date and your salary expectations (annually)
via our internal system.

Just

click APPLY on the top right side of this page or

here

and you will be redirected to our application site.

Bavarian Nordic Fraunhoferstraße 13 82152 Martinsried www.bavarian-nordic.com


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Fuldtidsjob
Udlandet (øvrige)
Kemi, Biotek & Materialer
Medicinal & Sundhed
Samfundsvidenskab
Sprog, Media & Kommunikation
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Projektledelse



Bavarian Nordic A/S - hurtigt overblik


Placering
Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
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https://jobbank.dk/job/1450059/