QA Operations Lead: CAPA, Deviations & GMP

No deviation; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

No deviation is seeking a QA Operations Executive (Process) to provide QA oversight across Manufacturing and Quality Control to ensure cGMP compliance and support continuous improvement of the Quality Management System.

You will manage deviations, CAPAs, change controls, document reviews, batch disposition, and audit readiness while collaborating with cross-functional teams to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or a related technical discipline.
• Minimum 2 years of Quality Assurance experience within the pharmaceutical, biotechnology, medical device, or other regulated industries.
• Good understanding of GMP, cGMP, and pharmaceutical regulatory requirements.
• Experience working with Quality Management Systems (QMS).
• Knowledge of deviation management, CAPA, change control, risk assessments, and investigation processes.
• Strong documentation review and GMP compliance experience.
• Ability to communicate effectively and collaborate with cross-functional stakeholders.
• Ability to apply risk-based decision-making and quality assurance principles.
• Strong analytical and problem-solving skills with the ability to conduct investigations and identify root causes.
• Ability to work independently while supporting continuous quality improvement initiatives.

Responsibilities

• Provide QA oversight for Manufacturing and QC operations to ensure compliance with cGMP, regulatory requirements, and internal quality standards.
• Perform routine shopfloor quality oversight including housekeeping inspections, line clearance verification, process confirmations, facility walkdowns, and SOP compliance checks.
• Manage deviations, laboratory investigations, CAPAs, change controls, and risk assessments to ensure timely resolution and effective corrective actions.
• Authorize quality-related activities including Quality Tag Outs, conditional equipment releases, campaign changeovers, room releases, batch usage decisions, and release suitability.
• Review and approve GMP documentation including SOPs, analytical protocols and reports, Master Batch Records (paper and electronic), QC monographs, checklists, deviations, investigations, CAPAs, change controls, and validation documentation.
• Ensure batch documentation is complete, accurate, and compliant, initiating corrective actions where necessary.
• Support complaint investigations, internal audits, self-inspections, regulatory inspections, and quality risk assessments.
• Identify compliance gaps, recommend process improvements, and elevate critical quality issues when required.
• Own and maintain quality procedures, SOPs, and checklists while delivering training to relevant personnel.
• Act as a Subject Matter Expert (SME) for quality processes and support continuous improvement initiatives.
• Support Quality Product Reviews (QPR), quality metrics, KPI reporting, and other Quality Management System activities.
• Comply with Environmental Health and Safety (EHS) policies and contribute to workplace safety objectives.

Skills

GMP knowledge

QMS

Deviation management

CAPA

Change control

Risk assessments

Investigation

Documentation review

Cross-functional collaboration

Analytical skills

Problem-solving

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related

Job description

No deviation is seeking a QA Operations Executive (Process) to provide QA oversight across Manufacturing and Quality Control to ensure cGMP compliance and support continuous improvement of the Quality Management System.

You will manage deviations, CAPAs, change controls, document reviews, batch disposition, and audit readiness while collaborating with cross-functional teams to ensure product quality and regulatory compliance.