QC Automation Project Manager

6 days ago

Copenhagen, Copenhagen, Denmark PQE Group Full time

PQE Group Copenhagen, Capital Region of Denmark, Denmark

QC Automation Project Manager

Since 1998, PQE Group has been a global leader in the Pharmaceutical and Medical Device sectors, providing top-tier consulting services. With a workforce of over 2,000 employees from 45+ nationalities and 32 subsidiaries across Europe, Asia, and the Americas, we offer a dynamic, multicultural, and challenging work environment.

Joining PQE means becoming part of an international team, engaging in cutting-edge projects, and collaborating with professionals from around the world.

Due to our continuous growth, PQE Group is seeking a QC Automation Project Manager to support one of our clients in Copenhagen, Denmark .

Responsibilities include, but are not limited to:

  • Lead QC laboratory digitalization and automation projects , ensuring successful implementation of LIMS, CDS, and other lab informatics solutions.
  • Manage end-to-end validation of computerized systems, including preparation of Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports, following GAMP 5 guidelines and CFR 21 Part 11 compliance .
  • Oversee the integration of laboratory systems (LIMS, CDS, ELN) with enterprise platforms, ensuring seamless data flow and compliance with Data Integrity principles .
  • Drive process improvements in QC operations using Lean Six Sigma methodologies , identifying opportunities for automation and workflow optimization.
  • Coordinate and collaborate with internal and external stakeholders, including IT, QA, QC, suppliers, and regulatory bodies , to ensure successful execution of automation projects.
  • Support Change Control and CAPA processes related to laboratory digitalization and automation.
  • Provide training and support to QC and IT teams on new laboratory automation systems, ensuring adoption and compliance.
  • Stay updated on new trends in lab automation, data integrity regulations, and quality systems , ensuring continuous improvement in QC operations.

Required Qualifications:

  • Degree in Chemistry, Engineering, Life Sciences, or related field.
  • Proven experience (5+ years) in QC Automation, LIMS implementation, or CSV in pharmaceutical or biotech industries.
  • Strong knowledge of GMP, GLP, GCP, CFR 21 Part 11, GAMP 5, and Data Integrity regulations .
  • Experience in validation of laboratory computerized systems , including writing and executing IQ, OQ, PQ .
  • Expertise in LIMS, CDS (Empower), ELN, and other QC lab informatics tools .
  • Familiarity with Lean Six Sigma principles for process improvement.
  • Strong project management skills , with experience in managing cross-functional teams and multiple stakeholders.
  • Excellent communication skills and ability to work in a fast-paced, highly regulated environment.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Consulting
  • Pharmaceutical Manufacturing
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