全职 QA Operations Executive (Process) 工作, 薪水, No Deviation Pte Ltd 公司招聘中 - Ricebowl

Position Overview

The QA Operations Executive (Process) is responsible for providing Quality Assurance oversight to ensure compliance with current Good Manufacturing Practices (cGMP) across Manufacturing and Quality Control operations. The role supports quality-related activities including batch disposition, deviation management, change control, CAPA oversight, documentation review, release authorizations, and audit readiness. Working closely with cross-functional teams, the incumbent ensures product quality, regulatory compliance, and continuous improvement of Quality Management System (QMS) processes while promoting a strong quality culture.

Key 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 escalate 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.

Required 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.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.