Senior QA Specialist - Validation

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

ANTER CONSULTING PTE. LTD. seeks an experienced Quality Assurance professional to support a pharmaceutical/biopharmaceutical manufacturing campus in Singapore.

The role provides QA oversight of commissioning, qualification and validation activities, focusing on reviewing equipment and QC instrument qualification deliverables ahead of clinical and commercial manufacturing. The candidate will collaborate with Manufacturing, Engineering, QC, MS&T and IT to maintain cGMP compliance, ensure data

Qualifications

• Substantial validation experience within a QA function in regulated pharma/biopharma manufacturing.
• Strong understanding of cGMP and regulatory expectations with practical application.
• Experience overseeing manufacturing, QC, validation and related operations.
• Proven ability to manage investigations, deviations, CAPA and change control.

Responsibilities

• Provide QA guidance during commissioning, qualification and validation of equipment, utilities, facilities and QC systems.
• Review and approve qualification/validation documents, including protocols, reports and deviations.
• Support site validation covering process, facility, aseptic and cleaning validation.
• Collaborate with Manufacturing, Engineering, QC, MS&T and IT to resolve quality issues.
• Provide on-the-floor QA support to ensure cGMP compliance and data integrity.
• Support core quality processes with timely, accurate documentation andControls.
• Assess quality risks, support risk-based decisions and follow up on mitigations.
• Prepare for audits and regulatory inspections; engage in health authority interactions.

Skills

QA oversight

cGMP

validation

regulatory readiness

data integrity

audit support

risk assessment

documentation

Education

Bachelor's or Master's in Biotechnology/Pharmaceutical Sciences/Engineering

Tools

QC instruments qualification

computerised systems

eQMS / digital tools

Job description

We are seeking an experienced Quality Assurance professional to support the start-up of a pharmaceutical and biopharmaceutical manufacturing campus in Singapore. This role provides QA oversight of commissioning, qualification and validation activities, with a particular focus on reviewing and approving equipment and QC instrument qualification deliverables ahead of clinical and commercial manufacturing. Depending on the assignment, the scope may cover facilities involved in raw materials, biologics, small-molecule intermediates, conjugation, sterile filling, lyophilisation, packaging, quality control and warehousing.

Contract Details

• Duration: 1-year contract.
• Location: Singapore.
• Target onboarding: As soon as possible.
• Planned interview window: 12-14 October 2026.

Key Responsibilities

• Provide QA guidance and oversight throughout the commissioning, qualification and validation of manufacturing equipment, utilities, facilities, QC instruments and computerised systems.
• Review and approve qualification and validation documentation, including protocols, reports, supporting records, deviations and associated changes.
• Support site validation processes covering process, facility, aseptic and cleaning validation.
• Work closely with Manufacturing, Engineering, QC, MS&T and IT to resolve quality issues and support compliant project delivery.
• Provide on-the-floor QA support to ensure activities meet cGMP requirements, approved procedures and the site pharmaceutical quality system.
• Support core quality processes, ensuring timely, accurate documentation and appropriate data integrity controls.
• Assess and communicate quality risks, support risk-based decisions and follow up on mitigation actions.
• Interpret GxP expectations and contribute to audit preparation, regulatory inspections and health authority interactions.
• Analyse quality metrics and performance trends, identifying opportunities to improve compliance and operational reliability.
• Deliver quality training and coach junior colleagues on quality processes, systems, digital tools and compliance practices.

Requirements

• Bachelor's or Master's degree in Biotechnology, Pharmaceutical Sciences, Engineering, Biology, Chemistry or a related scientific or technical discipline.
• Substantial validation experience within a QA function in regulated pharmaceutical or biopharmaceutical manufacturing.
• Experience providing quality oversight of manufacturing, QC, validation and related operational activities.
• Strong understanding of cGMP, pharmaceutical quality systems and regulatory expectations, with the ability to apply requirements in operational settings.
• Experience supporting investigations, deviation management, CAPA, change control and quality risk assessments.
• Strong analytical and problem‑solving skills, with sound judgement when assessing complex quality issues.
• Effective written and verbal communication, stakeholder management, collaboration and influencing skills.
• Ability to manage competing priorities and adapt to changing project and manufacturing needs.

Preferred Experience

• Experience supporting major validation programmes, new facility start-ups or greenfield and brownfield projects.
• Exposure to biologics, synthetic active pharmaceutical ingredients, sterile or aseptic processing, or multiple pharmaceutical manufacturing areas.
• Experience using digital pharmaceutical systems, data visualisation or analytics tools to improve quality performance.
• Experience supporting digital, automation or AI-enabled initiatives within GxP environments, with an understanding of the testing lifecycle.
• Familiarity with Lean, Six Sigma or other operational excellence approaches.