Quality Assurance Specialist

Bavarian Nordic A/S

Fuldtidsjob
Udlandet (øvrige)

To strengthen our Quality Management System and

Quality Assurance
Department in

Morrisville, North Carolina
we are searching for a qualified

Quality Assurance Specialist

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, and with the Clinical Development and Pharmacovigilance teams
  • Assist in maintaining and continuously improving the Quality Management System at Bavarian Nordic and increasing 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 Investigations applicable to GCP and GVP areas. Participate in root cause analysis, impact assessment, corrective planning, follow up and trend analysis
  • 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 and train staff, and coordinate training activities
  • Maintain Clinical QA trackers, folders and documentation, ensuring they are 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
  • Must be able to 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; ability to work within matrix environment, internal team and external CROs
  • Must be an effective problem solver and solution finder

Your Profile

  • Minimum 2-3 years of work experience in the pharmaceutical or biotech industry, preferably in the area of Quality Assurance
  • BA/BS Degree in relevant field required
  • Experience managing and tracking Key Quality Indicators and Quality Issues
  • In-dept knowledge of PV compliance would be an asset, especially post marketing
  • In-depth knowledge of Office standard applications (Word, Excel, PowerPoint)

Your prospect

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

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Fuldtidsjob
Udlandet (øvrige)
Medicinal & Sundhed
Samfundsvidenskab
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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www.bavarian-nordic.com


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https://jobbank.dk/job/1451511/