QC Validation Consultant (6-Month Contract)
Location: Singapore (Onsite, project-dependent)
Start: ASAP / Short notice preferred
Overview
We are engaging a QC Validation Consultant to support validation and qualification activities within a regulated environment. This role suits someone who is hands-on with C&Q execution, documentation, and data integrity expectations across QC systems and/or analytical instruments.
Key Responsibilities
- Support validation and qualification activities for regulated QC systems and/or analytical instruments
- Execute and document Commissioning & Qualification (C&Q) activities (IQ/OQ/PQ where applicable)
- Prepare and review validation deliverables (protocols, test scripts, traceability matrices, summaries, reports)
- Support compliance deliverables aligned to data integrity and system validation requirements
- Partner closely with internal stakeholders (QC, Engineering, Automation/IT, QA) to meet timelines
- Support deviation/exception documentation, investigation inputs, and closure packs where required
- Maintain strong documentation discipline and audit readiness
Requirements
- 3-5 years of relevant validation experience (CSV / C&Q / equipment or instrument qualification
- Experience in pharma/biotech/medical device manufacturing and QC labs
- Familiarity with key standards and guidelines: ISPE Baseline Guide Vol 5 (C&Q, 2nd Edition), GAMP 5, 21 CFR Part 11, EU Annex 11, USP 1058
- Strong technical writing and structured documentation skills
- Comfortable working under tight timelines and shifting priorities
Why This Role
- High-impact project work in a regulated environment
- Broad exposure across QC validation deliverables and cross-functional teams
- Opportunity to contribute to audit-ready outcomes and right-first-time execution
- Please submit your resume in Word or PDF format to Tahmid Bin Zafar at , quoting the job title and reference no. TZ35319. We regret that only shortlisted candidates will be notified.
Desired Skills and Experience
3-5 years of relevant validation experience (CSV / C&Q / equipment or instrument qualification
Experience in pharma/biotech/medical device manufacturing and QC labs
Familiarity with key standards and guidelines: ISPE Baseline Guide Vol 5 (C&Q, 2nd Edition), GAMP 5, 21 CFR Part 11, EU Annex 11, USP 1058
