Senior Qualification & Validation Specialist (GMP)

P-CON MANAGEMENT PTE. LTD.; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

P-Con Management PTE. LTD. in Singapore is seeking an experienced Qualification & Validation Specialist to oversee validation activities in a GMP environment.

You will work with Quality, Engineering, Manufacturing, and Technical Services to keep facilities, systems, and processes qualified and compliant. The role covers qualification across facilities, utilities, equipment, processes, cleaning, CSV, and technology transfer, with emphasis on documentation, risk management, and continuous

Qualifications

• Bachelor's degree or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences, or related discipline.
• Minimum 5 years of qualification and validation experience in pharma/regulated industries.
• Experience with FUE, CSV, manufacturing process validation, cleaning, sterilization validation.
• Experience supporting audits, inspections, regulatory programs; technology transfer is a plus.

Responsibilities

• Provide quality oversight for qualification and validation activities across the validation lifecycle.
• Review and approve validation strategies to ensure GMP and regulatory compliance.
• Support validation activities for facilities, utilities, equipment, processes, cleaning, CSV, and tech transfer.
• Prepare, review, and approve validation documentation (VMP, IQ/OQ/PQ, risk assessments, TRMs, summaries).
• Support change control, deviation investigations, CAPA, and risk-based validation approaches.

Skills

Analytical skills

Problem-solving

Quality systems

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation

CSV/CSV validation

Education

Bachelor's degree in Engineering/Pharma

Tools

Kneat

Veeva

Job description

P-Con Management PTE. LTD. in Singapore is seeking an experienced Qualification & Validation Specialist to oversee validation activities in a GMP environment.

You will work with Quality, Engineering, Manufacturing, and Technical Services to keep facilities, systems, and processes qualified and compliant. The role covers qualification across facilities, utilities, equipment, processes, cleaning, CSV, and technology transfer, with emphasis on documentation, risk management, and continuous