Odgovorna Oseba Za Sproščanje Zdravil Na Trg (m/ž/d) / Qp (m/f/d)

Novartis

Ljubljana, Slovenia
On-site
Decision on release of finished product batches
Certification of products according to annex 16
Review and approval of quarantined finished product shipments
Novartis is seeking a qualified individual for the role of Responsible Person for the release of medicinal products in Ljubljana, Slovenia, as they establish a new aseptic manufacturing unit set to commence operations in 2026. The ideal candidate will have at least two years of relevant experience in the pharmaceutical industry, with responsibilities including product certification, quality control, and compliance

Job Summary

  • You will be responsible for the decision on the release of finished product batches and certification of products according to Annex 16.
  • The role involves reviewing and approving quarantined finished product shipments and master batch manufacturing records, as well as participating in investigations and risk assessments.
  • Novartis offers a competitive salary package, annual bonus, flexible work arrangements, and numerous learning and development opportunities.

Matching Summary

Match Score: 85

Novartis is seeking a qualified individual for the role of Responsible Person for the release of medicinal products in Ljubljana, Slovenia, as they establish a new aseptic manufacturing unit set to commence operations in 2026. The ideal candidate will have at least two years of relevant experience in the pharmaceutical industry, with responsibilities including product certification, quality control, and compliance.

Skills & Requirements

Must-have

  • decision on release of finished product batches
  • certification of products according to Annex 16
  • review and approval of quarantined finished product shipments
  • investigations of critical complaints, OOS, OOT results
  • risk assessments, audits, and inspection participation
  • Good Manufacturing Practice (GMP) training delivery

Nice-to-have

  • teamwork
  • results-oriented
  • problem-solving
  • continuous learning

Key Requirements

  • University degree in Pharmacy
  • Minimum 2 years of practical experience in pharmaceutical industry
  • Active knowledge of English language

Work Rights

Not specified

Tailored Resume

Cover Letter