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LGC Group

Sells oligos, probes, primers, viral materials

Quality Assurance Manager - Qualification/Validation

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeBerlin, GermanyNo salary listedIn-person

About the Job

Requirements

  • A completed degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering sciences, or a comparable technical or scientific field.
  • At least 2 years of GMP experience in qualification, validation, or Quality Assurance.
  • Sound knowledge of EU GMP Annex 15, Annex 11, ICH Q9, and GAMP 5.
  • Knowledge of ICH Q9 and risk-based qualification approaches.
  • Experience qualifying facilities, laboratory equipment, and GMP utilities.
  • Experience reviewing URS, risk analyses, and IQ/OQ/PQ documentation.
  • Experience participating in interdisciplinary projects with Engineering, Production, QC, and QA.
  • Experience participating in FAT/SAT.
  • Very good IT skills, especially MS Office.
  • Very good written and spoken German and English.
  • Engagement, communication skills, resilience, reliability, teamwork, and a sense of responsibility.

Responsibilities

  • Review and approve URS, risk analyses, and qualification and validation documentation (DQ, IQ, OQ, PQ, CSV/CSA) in consultation with the Senior QA Manager or Head of QA.
  • Ensure GMP-compliant qualification and validation of facilities, equipment, utilities, and computerized systems in accordance with Annex 15, Annex 11, and 21 CFR Part 11.
  • Provide QA oversight for qualification, validation, requalification, and monitoring activities, including GMP-relevant utility systems.
  • Assess risks and traceability between requirements, risk analyses, test cases, and qualification evidence in accordance with ICH Q9.
  • Review and assess deviations, root-cause analyses, CAPAs, and trend data for their impact on qualification and validation status.
  • Assess technical changes from a QA perspective and support risk-based qualification strategies and GMP-compliant decision-making.
  • Represent QA in technical projects, including FAT, SAT, commissioning, and start-up, and provide GMP advice to Engineering and project teams.

Desired Qualifications

  • Experience in pharmaceutical production and/or analytics.
  • Knowledge of chemical, biochemical, or microbiological analytics.

About the Company

LGC Group

Sells oligos, probes, primers, viral materials

LGC Group provides life sciences tools and solutions, including oligo components, probes, primers, and recombinant viral materials, plus proficiency-testing schemes for areas like food safety. Its products support detection and development in healthcare through mass spectrometry, immunoassays, and nucleic acid chemistry for vaccines, diagnostics, and therapies. The company differentiates itself with a broad portfolio and global testing services that help customers from diagnostics to vaccine development. Its goal is to improve healthcare outcomes and public safety by enabling accurate testing and high-quality scientific tools.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
1841

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