Senior Validation & QA Lead

pharmagend global medical services pte. ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

pharmagend global medical services pte. ltd. in Singapore is hiring a Validation Specialist to lead qualification and validation activities in a regulated pharmaceutical manufacturing environment.

You will prepare and review URS, DQ/IQ/OQ/PQ, and coordinate with cross-functional teams to meet schedules while ensuring regulatory compliance. 5–7 years of relevant experience and proficiency with MS Word, Excel, Access, PowerPoint and Explorer are required; strong teamwork and problem-solving are

Qualifications

• Degree in a scientific discipline or equivalent.
• 5-7 years’ experience in pharmaceutical manufacturing.
• Experience in a regulated industry preferred.
• Proficient in MS Word, Excel, Access, PowerPoint, and Explorer.

Responsibilities

• Prepare and review qualification documents (URS, DQ, IQ, OQ, PQ) per regulatory guidelines.
• Execute qualification and validation activities (process, cleaning, computer systems, equipment, utilities, facility).
• Lead qualification/validation knowledge and apply principles practically.
• Coordinate with cross-functional teams and external service providers to meet schedules.
• Review change controls; perform risk assessments on proposed changes.
• Write, review and revise validation SOPs per regulatory guidelines.
• QA oversight during validation processes.
• Manage incidents and deviations related to validation/qualification.
• Perform compliance reviews of deviations, investigations, CAPAs related to qualification/validation.
• Suggest improvements to Validation Master Plan and validation strategies.
• Cross train and develop expertise in other validation areas.
• Interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

Skills

Quality assurance

Regulatory compliance

GxP experience

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

PowerPoint

Internet Explorer

Job description

pharmagend global medical services pte. ltd. in Singapore is hiring a Validation Specialist to lead qualification and validation activities in a regulated pharmaceutical manufacturing environment.

You will prepare and review URS, DQ/IQ/OQ/PQ, and coordinate with cross-functional teams to meet schedules while ensuring regulatory compliance. 5–7 years of relevant experience and proficiency with MS Word, Excel, Access, PowerPoint and Explorer are required; strong teamwork and problem-solving are