Skip to content
New Job?Nejo!

Your personal AI career agent

Back
NONovartis Pharmaceutical Manufacturing GmbH

Senior QA Operations Expert; Qualified Person(m/w/x)

Schaftenau
from 73,122.9 / year
Full-timeWith Home OfficeSenior
Apply now

Certifying and releasing secondary packed drug product batches for commercial purposes at a pharmaceutical manufacturing site. Proven experience in Audit and Inspection Management required. 4-day work week, company car for private use.

Requirements

  • Proven experience in Audit and Inspection Management
  • Strong working knowledge of cGMP and GxP requirements
  • Hands-on experience with Release Management and batch disposition
  • Solid expertise in Quality Management Systems (QMS), Quality Assurance, and Quality Compliance
  • Background in Technical Operations with technological aptitude
  • Demonstrated people leadership capability
  • Sound decision-making in patient-focused environment
  • Strong collaboration skills
  • Strong communication skills
  • Strong problem-solving skills
  • Ability to navigate ambiguity effectively
  • High commitment to data integrity
  • Digital proficiency
  • Audit & Inspection Management experience
  • Good Manufacturing Practices (cGMP) knowledge
  • Release Management experience
  • Quality Management Systems knowledge
  • Technical Operations experience
  • GxP Experience
  • People Management experience
  • Quality Assurance knowledge
  • Quality Compliance knowledge
  • Technological Expertise
  • Patient Safety focus
  • Collaboration skills
  • Regulatory requirements knowledge
  • Dealing with ambiguity
  • Problem Solving Skills
  • Communication skills
  • Data Integrity commitment
  • Digital saviness
  • Leadership skills
  • Decision Making skills

Tasks

  • Certify and release secondary packed drug product batches for commercial purposes
  • Ensure compliance with AMG, Marketing Authorization, and GMP requirements
  • Verify product quality and documentation for batch release
  • Lead critical negotiations with internal and external stakeholders
  • Provide coaching, performance management, and capability building
  • Manage technical operations and provide day-to-day quality support
  • Collaborate across functions to align on priorities, risks, and delivery commitments
  • Participate in escalations, recalls, and critical complaint investigations
  • Evaluate process changes and deviations
  • Plan and deliver projects to agreed quality, scope, and timelines
  • Ensure inspection and audit readiness
  • Coordinate responses and drive timely, sustainable CAPAs
  • Support preparation for and participation in audits and inspections
  • Maintain and improve Quality Management System processes
  • Oversee release management activities
  • Report technical complaints, adverse events, and special case scenarios within 24 hours
  • Coordinate distribution of marketing samples as needed

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Native

Tools & Technologies

  • cGMP
  • GxP
  • QMS
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.

Not a perfect match?

100+ Similar Jobs in SchaftenauView all
  • Novartis

    QA Operations Expert(m/w/x)

    Full-time/Part-timeWith HomeofficeExperienced
    Schaftenau
    from 65,605.54 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    QA Operations Expert(m/w/x)

    Full-time/Part-timeWith HomeofficeExperienced
    Schaftenau
    from 65,605.54 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    QA Specialist Operations(m/w/x)

    Full-time/Part-timeWith HomeofficeExperienced
    Kundl
    from 58,199.96 / year
  • Novartis

    QA Compliance Expert(m/w/x)

    Full-timeWith HomeofficeExperienced
    Schaftenau
    from 64,023.54 / year
  • Novartis Pharmaceutical Manufacturing GmbH

    QA Specialist Operations(m/w/x)

    Full-time/Part-timeWith HomeofficeExperienced
    Kundl
    from 59,781.96 / year
View all 100+ similar jobs
Apply now

Nejo is an AI – results may be incomplete or contain mistakes