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Quality Validation Specialist - SGGK1 at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Validation, Equipment Qualification, Utility Qualification, Computer System Validation, GMP Compliance, GxP Compliance, FDA Regulations, EMA Regulations, Risk-Based Validation, Lifecycle Documentation, MES, DeltaV, PLC, Facility Qualification, Life Sciences Manufacturing, Quality Review

Industry

Pharmaceutical Manufacturing

Description

Job Title: Quality Validation Specialist (Contract) Openings: 5 positions Duration: 6–8 months Location: Singapore Industry: Life Sciences Manufacturing About the Role We are hiring Quality Validation Specialists to support validation and compliance activities within the life sciences manufacturing sector. This contract role is critical to ensuring equipment, automation, and facility systems meet global regulatory standards. Key Responsibilities Conduct validation quality review of lifecycle documents and protocols. Support Equipment & Utility Qualification (IQ/OQ/PQ). Review Automation Computer System Validation (CSV) protocols for MES, DeltaV, PLC, and related systems. Perform Facility Qualification reviews and ensure documentation accuracy. Ensure compliance with GMP, GxP, FDA, EMA, and other regulatory requirements. Collaborate with QA, Engineering, Automation, and Manufacturing teams to resolve validation gaps. Provide risk‑based recommendations to strengthen validation processes. Qualifications & Experience Bachelor’s degree in Engineering, Life Sciences, or related discipline. 5+ years of validation/quality experience in pharma or medical devices. Strong knowledge of GMP/GxP compliance and validation lifecycle. Hands‑on experience with equipment, automation, and facility qualification. Familiarity with CSV documentation and risk‑based validation approaches. Excellent communication and documentation skills.

Responsibilities

The role involves conducting quality reviews of validation lifecycle documents and supporting equipment, utility, and facility qualifications. It also requires reviewing automation CSV protocols and ensuring compliance with global regulatory standards like GMP and FDA.