Site QA Supervisor (West/ Pharma MNC) #HAC

Job Scope: • Site Quality Management • Lead and manage on-site quality assurance activities in manufacturing, packaging, warehouse and supporting areas to ensure compliance with GMP, the Quality Management System (QMS), and applicable regulatory requirements. • Develop Site QA work plans and allocate resources for routine shop-floor monitoring, GMP walkthroughs, documentation review and material release activities. • Supervise, coach and develop Site QA personnel to ensure consistent and effective execution of assigned quality oversight activities. • Conduct routine GMP inspections, focused audits, internal self-inspections and quality risk assessments; identify, escalate and drive timely resolution of quality and compliance issues. • Provide real-time QA oversight of critical manufacturing activities, process controls, line clearance, material status labeling, personnel practices, housekeeping, documentation practices and data integrity. • Work closely with Manufacturing, Warehouse, QC, Engineering and Validation functions to resolve site quality issues and drive continuous improvement. • Material Release • Review and approve documentation supporting the release of raw materials and packaging materials for use, ensuring compliance with approved supplier status, testing status, storage requirements, labeling and applicable specifications. • Oversee Site QA activities related to material release, material status control and disposition of non-conforming or abnormal materials. • Review master cleaning records, line clearance records, SOPs and related controlled documents to ensure GMP compliance and alignment with actual site practices. • Cleaning Validation System • Establish, maintain and continuously improve the site cleaning validation program and associated quality system. • Develop, review and approve cleaning validation policies, SOPs, validation plans, protocols, reports and related technical documentation. • Lead or coordinate cleaning validation risk assessments, including equipment and product grouping, worst-case product selection, residue limit establishment, sampling strategies, analytical methods, acceptance criteria and revalidation requirements. • Review and approve cleaning validation protocols, cleaning validation reports, cleaning verification reports and periodic review reports. • Provide QA oversight during cleaning validation execution • Review cleaning-related deviations, changes, CAPAs and impact assessments, and assess potential impact on product quality, cross-contamination control and validation status. • Conduct periodic review of cleaning procedures and validation status, identify revalidation needs, and implement continuous improvements to cleaning processes and cross-contamination control measures. • Deviation, Change Control and CAPA Management • Lead or participate in investigations, assessment, review and follow-up of deviations, incidents, change controls, quality risk assessments and CAPAs related to site operations. • Lead cross-functional investigations for critical, recurring or systemic quality issues and ensure robust root cause analysis is performed. • Ensure corrective and preventive actions are implemented within agreed timelines and verify their effectiveness. • Perform periodic trend analysis of deviations, audit findings, cleaning-related issues and other site quality metrics to identify improvement opportunities. • Customer Audit and Regulatory Inspection Management • Lead Site QA preparation, coordination and support for customer audits, regulatory inspections, third-party audits and internal audits. • Act as the primary Site QA contact for matters related to shop-floor quality management, material release, cleaning management and cleaning validation during audits and inspections. • Coordinate the preparation and review of audit documentation, including material release records, cleaning and line clearance documentation, cleaning validation documents, deviations, change controls and CAPA evidence. • Support audit hosting, coordinate responses to audit observations, and ensure responses are accurate, timely and scientifically justified. • Develop and review audit remediation plans, assign responsible owners and due dates, and track CAPA completion and effectiveness. • Maintain awareness of Singapore Health Sciences Authority (HSA) GMP requirements and relevant regulatory expectations in target markets. • Team Leadership and Quality System Improvement • Manage Site QA team performance, including recruitment support, training, task allocation, coaching and performance development. • Deliver or coordinate GMP, data integrity, cleaning management, deviation management and site quality training for relevant site personnel. • Contribute to the establishment, maintenance and continuous improvement of the site Quality Management System. • Promote a proactive quality culture and ensure quality risks are effectively communicated and managed across functions. • Perform other quality-related duties as assigned by the QA Manager or Head of Quality. Qualifications and Experience • Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Chemistry, Biotechnology, Quality Management or a related discipline. • Minimum 5 years of relevant experience in pharmaceutical QA, manufacturing quality, site quality management and/or validation. • At least 2 years of supervisory, team leadership or people management experience in a Site QA, Quality or related function. • Strong knowledge of Singapore HSA GMP requirements and international GMP standards. Experience with PIC/S GMP, EU GMP, FDA cGMP and/or WHO All qualified candidates please send your resume to anna.chen@recruitexpress.com.sg Anna Chen jiaxin CEI No: R25157621 Recruit Express Pte Ltd EA License: 99C4599