The posting
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 [email protected]
Anna Chen jiaxin CEI No: R25157621 Recruit Express Pte Ltd EA License: 99C4599
