Salary: Up to SGD $7000 - 9,500 / month (Base) + SGD 250 Monthly Transport Allowance
About the Role
Leading Global Pharmaceutical Multinational (MNC) is seeking a high-caliber Senior Quality Validation Specialist to spearhead the qualification and validation of automated systems for a world-class pharmaceutical manufacturing plant in Tuas. This critical, fast-paced 6-month contract requires a seasoned professional capable of providing technical leadership, ensuring flawless compliance, and driving the end-to-end validation lifecycle for both laboratory and manufacturing automated operations.
Key Responsibilities
- Validation Leadership: Lead and oversee the preparation, review, and execution of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ) for complex automated and computerized systems.
- Automated & Lab Systems Validation: Provide deep, hands-on expertise in the qualification of automated systems supporting manufacturing (e.g., PLC/SCADA, MES) and/or advanced laboratory operations (e.g., LIMS, Empower, instrument software integrations).
- Quality Assurance & Compliance: Ensure all validation activities strictly comply with global Good Manufacturing Practices (GMP), GAMP 5 methodologies, and stringent Data Integrity standards (21 CFR Part 11 / ALCOA+ principles).
- Stakeholder & Risk Management: Partner closely with Automation, IT, Quality Control, and QA teams to manage project timelines. Drive risk assessments (FMEA) and proactively mitigate validation delays.
- Discrepancy & Deviation Management: Provide senior-level oversight for validation deviations. Lead thorough root-cause investigations and implement robust Corrective and Preventive Actions (CAPA).
skills and experiences required
- Industry Experience: Minimum of 5 years of robust experience in a highly regulated pharmaceutical or biopharmaceutical manufacturing environment.
- Core Technical Expertise: At least 3 years of dedicated track record in successfully delivering validated laboratory systems qualifications.
- Automation Savvy: Strong hands-on experience and structural understanding of automated systems and computerized system validation (CSV) frameworks supporting lab or plant operations.
- Soft Skills: Proven ability to work independently, influence cross-functional teams, and deliver results under tight project schedules.
Please click on the 'apply' button to apply online. For more information, please reach out to Wai Ling Tai. (EA: 94C3609 / R1110392 )