(Pharma Manufacturing MNC) QA Site Manager (Must Have API QA Exp) #HJC

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is seeking a Site Quality Management leader to oversee on-site QA across manufacturing, packaging, warehouse and supporting areas in line with GMP and QMS requirements.

You will develop QA work plans, supervise QA staff, and conduct GMP inspections, audits and risk assessments while ensuring data integrity and cross-functional collaboration with Manufacturing, Validation and Regulatory teams.

Qualifications

• Bachelor’s degree or above in Pharmacy or 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.
• Strong knowledge of Singapore HSA GMP requirements and international GMP standards. Experience with PIC/S GMP, EU GMP, FDA cGMP and/or WHO GMP is preferred.
• Demonstrated experience in establishing, maintaining and executing a cleaning validation system.
• Strong experience in shop-floor quality oversight, material release, warehouse quality management, line clearance, deviation management, change control, CAPA, quality risk management and data integrity.

Responsibilities

• Lead on-site quality assurance activities across manufacturing, packaging, warehouse and supporting areas to ensure GMP, QMS and regulatory compliance.
• 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 effective execution of quality oversight.
• Conduct routine GMP inspections, focused audits, internal self-inspections and quality risk assessments; identify and drive timely resolution of issues.
• Provide real-time QA oversight of critical manufacturing activities, process controls, line clearance, labeling and data integrity.
• Work closely with Manufacturing, Warehouse, QC, Engineering and Validation to resolve site quality issues and drive continuous improvement.

Skills

QA Oversight

GMP Knowledge

Leadership

Quality Risk Management

Data Integrity

Audit Management

Cross-functional Collaboration

Education

Bachelor’s degree in Pharmacy or related field

Job description

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, escal 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.
• Minimum5 years of relevant experiencein pharmaceutical QA, manufacturing quality, site quality management and/or validation.
• At least 2 years of supervisory, team leadership or people management experiencein 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 GMP is preferred.
• Demonstrated experience in establishing, maintaining and executing a cleaning validation system.
• Sound knowledge of cleaning validation lifecycle management, quality risk assessment, worst-case selection, residue limit setting, sampling and analytical strategies, acceptance criteria, validation protocols and report review.
• Strong experience in shop-floor quality oversight, material release, warehouse quality management, line clearance, deviation management, change control, CAPA, quality risk management and data integrity.
• Experience in preparing for and supporting customer audits, HSA inspections, regulatory inspections, third-party audits and/or internal audits, including audit response writing and CAPA follow-up.
• Strong leadership, communication, stakeholder management, problem-solving and decision-making skills.