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NONovartis Pharmaceutical Manufacturing GmbH

Quality Manager Pilot Plant(m/w/x)

Schaftenau
from 65,605.54 / year
Full-timeOn-siteManagement
Apply now

Overseeing pilot plant quality and compliance, including batch record review and deviation management. Bachelor's degree with 5+ years pharma quality experience required. Focus on drug-device combination products and ISO 13485.

Requirements

  • Bachelor’s degree (> 5 years pharma quality/operations) or Master’s degree (> 3 years pharma quality/operations) in Pharmaceutical Sciences, Biotechnology, Engineering, or related field
  • Experience with Drug Device combination products, ISO 13485, 21 CFR 820
  • Good knowledge of cGMP, working knowledge in technical development, production or QA
  • Sound scientific, technical, and regulatory knowledge
  • Strong organizational and decision-making skills
  • Strong ability to analyze and evaluate cGMP compliance
  • Knowledge of GxP requirements and experience with inspections
  • Flexibility for fast-paced, changing work environment
  • Knowledge of Manufacturing Process/Product Expertise
  • Fluent English and German (oral & written)
  • Communication Skills, Continuous Improvement mindset, Data integrity, Dealing with Ambiguity, Digital savviness, leadership, Problem Solving Skills, Regulatory Requirements knowledge, Collaboration

Tasks

  • Manage quality and compliance activities
  • Oversee manufacturing QA
  • Review batch records
  • Conduct failure investigations
  • Handle deviation and change controls
  • Perform release activities
  • Ensure cGMP/GxP compliance
  • Maintain compliance with ISO 13485 and 21 CFR 820
  • Ensure health authority registrations
  • Maintain facility and utility qualifications
  • Manage deviations, OOX, complaints, and investigations
  • Implement CAPAs
  • Ensure data integrity
  • Comply with GxP, regulatory, and HSE requirements
  • Support internal and external audits
  • Support transfer projects
  • Conduct qualification activities
  • Participate in document compilation
  • Revise and approve validations
  • Revise and approve transfers
  • Revise and approve SOPs
  • Revise and approve GxP documents

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Fluent
  • German – Fluent

Tools & Technologies

  • ISO 13485
  • 21 CFR 820
  • cGMP
  • GxP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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