Senior QA Lead - GMP Compliance & Cleaning Validation

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Manpower Staffing Services (Singapore) Pte Ltd. seeks a Lead Site QA to oversee on-site quality activities across manufacturing, packaging and warehouse to ensure GMP and QMS compliance.

You will develop site QA work plans, allocate resources for shop-floor monitoring, GMP walkthroughs, documentation review and material release, and lead a team to maintain data integrity. Require 5+ years in pharma QA with supervisory experience and knowledge of Singapore GMP; familiar with CAPA, deviations, and

Qualifications

• 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.
• Knowledge of Singapore HSA GMP requirements and international GMP standards. Experience with PIC/S GMP, EU GMP, FDA cGMP and/or WHO GMP
• Demonstrated experience in establishing, maintaining and executing a cleaning validation system.
• 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.

Responsibilities

• Lead and oversee on-site QA activities to ensure GMP compliance across manufacturing, packaging, warehouse and related areas.
• 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 for consistent execution of quality oversight tasks.
• Conduct routine GMP inspections, audits, internal self-inspections and quality risk assessments; identify and drive resolution of issues.
• Provide real-time QA oversight of critical manufacturing activities, process controls, line clearance, labeling, housekeeping, documentation and data integrity.
• Review and approve documentation supporting release of raw materials and packaging materials.
• Establish and continuously improve the site cleaning validation program and related quality system.
• Develop, review and approve cleaning validation policies, SOPs, validation plans, protocols, reports and related documentation.
• Lead or coordinate cleaning validation risk assessments including sampling strategies and acceptance criteria.
• Lead or participate in investigations, deviations, change controls, CAPAs and quality risk assessments.
• Coordinate preparation and review of audit documentation, including material release records and validation evidence.

Skills

GMP knowledge

QMS knowledge

Regulatory compliance

People management

Quality oversight

Documentation review

Audits & inspections

Data integrity

CAPA management

Cleaning validation

Education

Bachelor’s degree or above in Pharmacy/Pharmaceutical Science/Quality disciplines

Job description

Manpower Staffing Services (Singapore) Pte Ltd. seeks a Lead Site QA to oversee on-site quality activities across manufacturing, packaging and warehouse to ensure GMP and QMS compliance.

You will develop site QA work plans, allocate resources for shop-floor monitoring, GMP walkthroughs, documentation review and material release, and lead a team to maintain data integrity. Require 5+ years in pharma QA with supervisory experience and knowledge of Singapore GMP; familiar with CAPA, deviations, and