Qualification and Validation Specialist

About the Role P-Con Management is partnering with a leading pharmaceutical manufacturing organization in Singapore to identify an experienced Qualification & Validation Specialist to support quality oversight of validation lifecycle activities within a highly regulated GMP environment. This role offers the opportunity to work closely with Quality, Engineering, Manufacturing, and Technical Services teams to ensure facilities, systems, equipment, processes, and computerized systems remain qualified, validated, and compliant with applicable regulatory requirements. The successful candidate will play a key role in supporting validation activities across facility, utility, equipment, process, cleaning, computerized systems, and technology transfer projects while maintaining the highest standards of quality and patient safety. ________________________________________ Key Responsibilities Quality & Validation Oversight • Provide quality oversight for qualification and validation activities throughout the validation lifecycle. • Review and approve validation strategies to ensure compliance with GMP and regulatory expectations. • Support validation activities related to: • Facilities, Utilities & Equipment (FUE) • Computerized Systems Validation (CSV) • Manufacturing Process Validation • Cleaning, Sterilization and Disinfection Validation • Transportation Validation • Analytical Instruments and Laboratory Systems Documentation & Compliance • Prepare, review, and approve validation documentation, including: • Validation Master Plans (VMP) • IQ/OQ/PQ Protocols and Reports • Risk Assessments (FMEA, HACCP) • Traceability Matrices • Validation Summary Reports • Ensure documentation is completed accurately and in accordance with approved procedures and timelines. • Maintain inspection-ready documentation supporting validation activities. Quality Systems Support • Review and assess change control requests impacting validated systems. • Support deviation investigations, root cause analysis, and CAPA implementation. • Evaluate validation impact assessments and ensure appropriate mitigation measures are implemented. • Promote risk-based and science-based validation approaches aligned with industry best practices. Cross-Functional Collaboration • Partner closely with Engineering, Manufacturing, Quality Control, Automation, and Technical Services teams. • Support technology transfer activities and validation execution for new products, processes, systems, and facilities. • Participate in continuous improvement initiatives aimed at strengthening validation and compliance processes. Requirements Education • Bachelor's Degree or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences, or a related discipline. • Additional certifications in Validation, Quality Management, GMP, or Quality Systems would be advantageous. Experience • Minimum 5 years of qualification and validation experience within the pharmaceutical, biopharmaceutical, medical device, or other regulated industries. • Hands-on experience supporting qualification and validation activities involving: • Facilities, Utilities & Equipment (FUE) • Computerized Systems Validation (CSV) • Manufacturing Process Validation • Cleaning Validation • Sterilization and Disinfection Validation • Experience supporting audits, inspections, and regulatory compliance programs. • Exposure to technology transfer activities is advantageous. Technical Competencies • Strong knowledge of GMP requirements and validation lifecycle management. • Familiarity with global regulatory guidelines and industry standards including FDA, EMA, ICH, ISPE, ASTM, ISO, and PDA. • Experience developing and reviewing: • IQ, OQ, PQ Protocols • Validation Reports • Risk Assessments • Traceability Matrices • Knowledge of Quality Risk Management tools. • Experience with deviation management, CAPA, and change control systems. • Familiarity with paperless validation platforms and electronic quality management systems such as Kneat or Veeva is an advantage. • Understanding of Data Integrity principles and ALCOA+ expectations. Preferred Experience Candidates with experience in the following areas will have a distinct advantage: • Biologics, sterile, aseptic, or vaccine manufacturing environments. • Facility startup, commissioning, qualification, and validation projects. • Regulatory inspections conducted by HSA, FDA, EMA, MHRA, or other health authorities. • Technology transfer, process validation, and continuous process verification. • Computerized Systems Validation (CSV) and Digital Quality Systems. Personal Attributes • Strong analytical and problem-solving skills. • Excellent written and verbal communication abilities. • Capable of influencing stakeholders and working across multiple functions. • Able to manage multiple priorities within a fast-paced environment. • Self-driven, organized, and detail-oriented. • Committed to quality, compliance, and continuous improvement. Why Join Us? • Opportunity to support leading pharmaceutical and biopharmaceutical manufacturing organizations. • Exposure to large-scale validation, qualification, and technology transfer projects. • Work within highly regulated GMP environments and develop expertise across quality systems and compliance functions. • Expand your professional network within Singapore's growing life sciences industry. P-Con Management specializes in providing technical, quality, validation, and compliance professionals to the pharmaceutical, biopharmaceutical, and life sciences sectors across Singapore.