Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industriesPQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our constant growth, we are looking for a Validation consultant – QC Laboratory Equipment to support our projects in Singapore.
Key Responsibilities:
- Qualification Lifecycle Management: Plan, draft, and execute full lifecycle validation documentation (DQ, IQ, OQ, PQ, URS, Traceability Matrices, and Validation Summary Reports) for QC laboratory instruments (e.g., HPLC, GC, UV-Vis, Dissolution Testers, pH Meters, Balances).
- Computerized Systems Compliance: Ensure analytical equipment controlling software (e.g., Empower, OpenLab, LIMS) complies with 21 CFR Part 11, EU Annex 11, and Data Integrity principles (ALCOA+).
- Risk Assessments & Compliance: Perform Quality Risk Assessments (FMEA / GAMP5) and gap assessments for existing and new laboratory computerized systems.
- Routine Compliance Activities: Execute Periodic System Reviews (PSR), Audit Trail reviews, User Access Management, and backup/restore verification for laboratory systems.
- Deviations & Change Control: Manage and investigate qualification deviations, non-conformances, and Out-of-Specification (OOS) events related to equipment qualification. Initiate and manage Change Control protocols for system upgrades or modifications.
- Cross-functional Collaboration: Work closely with QC Analysts, Quality Assurance (QA), IT, and external vendors to support site startup, instrument onboarding, and regulatory audit readiness.
About you:
- Experience: 2 to 6+ years of hands-on experience in Equipment Qualification (CQV) and Computer System Validation (CSV) within a regulated pharmaceutical or biotech environment.
- Technical Expertise: Strong background in qualifying QC laboratory analytical instruments and familiarity with Chromatography Data Systems (CDS) like Empower, OpenLab, or LIMS.
- Regulatory Knowledge: Solid understanding of cGMP, GAMP5, Data Integrity (ALCOA+ principles), and 21 CFR Part 11 guidelines.
- Documentation Skills: Proven ability to independently write, execute, and review high-quality validation protocols, risk assessments, and technical summary reports.
- Soft Skills: Excellent analytical problem-solving skills, strong attention to detail, and the ability to work independently while managing cross-functional technical tasks.
- Education: Bachelor's Degree in Chemical Engineering, Biotechnology, Chemistry, Pharmacy, Automation, or a related scientific/technical discipline.
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.
