Site QA Leader: GMP, Audits & Compliance Excellence

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

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.