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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.
Job Responsibility
Lead and oversee the preparation, review, and execution of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ) for complex automated and computerized systems
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)
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)
Partner closely with Automation, IT, Quality Control, and QA teams to manage project timelines. Drive risk assessments (FMEA) and proactively mitigate validation delays
Provide senior-level oversight for validation deviations. Lead thorough root-cause investigations and implement robust Corrective and Preventive Actions (CAPA)
Requirements
Minimum of 5 years of robust experience in a highly regulated pharmaceutical or biopharmaceutical manufacturing environment
At least 3 years of dedicated track record in successfully delivering validated laboratory systems qualifications
Strong hands-on experience and structural understanding of automated systems and computerized system validation (CSV) frameworks supporting lab or plant operations
Proven ability to work independently, influence cross-functional teams, and deliver results under tight project schedules
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, and/or laboratory operations
A Bachelor’s Degree or Diploma in a relevant technical or scientific discipline