QA Supervisor - (Pharmaceutical / API Plant)

Manpower Staffing Services (Singapore) Pte Ltd; Singapore; Vor Ort; SGD 120.000 - 180.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP knowledge

QMS knowledge

Regulatory compliance

People management

Quality oversight

Documentation review

Audits & inspections

Data integrity

CAPA management

Cleaning validation

Ausbildung

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

Jobbeschreibung

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.
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.
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.
Lead or participate in investigations, assessment, review and follow‑up of deviations, incidents, change controls, quality risk assessments and CAPAs related to site operations. 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.
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.