Senior QA Executive

Position Overview

The Senior QA Executive is responsible for providing Quality Assurance oversight across Manufacturing and Quality Control operations to ensure compliance with current Good Manufacturing Practices (cGMP) and the site's Quality Management System (QMS). The role supports day-to-day manufacturing activities, quality systems, regulatory compliance, validation, and MES implementation while driving continuous quality improvement and inspection readiness. The incumbent will collaborate closely with cross-functional teams to maintain product quality, data integrity, and operational excellence throughout the product lifecycle.

Key Responsibilities

• Provide routine QA shopfloor and QC oversight, including facility walkthroughs, line clearance, housekeeping checks and SOP compliance.
• Review and approve batch records, QC documents, protocols, reports, deviations, CAPAs and change controls.
• Authorise equipment, room and campaign releases, Quality Tagouts and batch usage decisions.
• Manage deviations, laboratory investigations and unplanned events, including root-cause analysis and CAPA follow-up.
• Conduct risk assessments, gap assessments, self-inspections and audit-readiness activities.
• Support regulatory inspections, complaint investigations and quality improvement initiatives.
• Maintain relevant SOPs and checklists and provide training or coaching to team members.
• Monitor quality metrics, periodic product reviews and site KPI reporting.
• Ensure compliance with applicable cGMP, regulatory and EHS requirements.

• Participate in MES design-phase discussions for electronic batch records.
• Review and approve MES-related change controls.
• Review and approve Business Process Design and Business Process Model documentation.
• Approve validation forms and support DRCL activities.
• Provide QA oversight during water runs, placebo PQ runs and production qualification activities.
• Perform or coordinate 100% QA review and approval of PQ execution records.
• Support MES gap assessments, deviation management and resolution of system or process issues.
• Ensure MES implementation complies with GMP, data integrity and applicable validation requirements.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry or a related discipline.
• At least 2 years relevant experience for QA Executive level preferably 5 years for Senior QA Executive.
• Good knowledge of GMP, QMS, risk management, deviations, CAPA and pharmaceutical manufacturing.
• Strong communication, investigation, stakeholder-management and problem-solving skills.
• Senior candidates should be able to manage complex investigations, interpret regulatory requirements and coach junior staff.

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.