(WEST) Senior/Manager, Pharmacy (Quality Assurance) #HCY

Key Responsibilities

• Maintain and ensure the effectiveness of the Quality Management System (QMS) in compliance with GMP/GxP and regulatory requirements, ensuring all processes, procedures and documentation are current, implemented and audit-ready
• Provide QA oversight of compounding operations, including review and approval of procedures, documents, records, deviations, investigations CAPAs, change controls, gap assessment and product release decisions
• Oversee product release decisions, ensuring complete, accurate and compliant documentation prior to release
• Ensure deviations are thoroughly documented, investigated, and resolved with effective corrective and preventive actions to prevent recurrence
• Lead and coordinate internal, customer and regulatory audits, ensuring timely closure of audit findings and sustanined audit readiness
• Qualify, monitor, and audit external vendors and oversee incoming materials disposition
• Identify, assess and escalate quality and compliance risks to QA leadership with recommended mitigation actions
• Facilitate and lead Quality Management Reviews( QMR), tracking and reporting key quality metrics and driving continuous improvement initiatives to enhance quality systems and operational performance
• Develop and manage QA staff through competency assessments, structure training programmes and performance management, ensuring all personnel are qualified and trained in accordance with GMP requirements
• Build and maintain effective relationships with internal and external stakeholders on quality matters, including proactive management of customer feedback and quality concerns
• Provide strategic input into quality systems development, lead regulatory inspections, and contribute to the broader quality direction of the compounding hub

Key Requirements

• Degree in Pharmacy, Pharmaceutical Science, Life Sciences, Engineering, or a related discipline; advanced degree (MSc/PhD) is an advantage

• Minimum 10 years of relevant experience in QMS within the pharmaceutical, biotechnology, or medical device industry, with at least 2-3 years in a managerial role including experience leading managers or cross-functional teams
• Strong knowledge of GxP regulations, GMP compliance, and relevant regulatory requirements
• Strong understanding of QMS principles, validation, change control, and deviation management

For interested candidates, please send your most recent and updated resume to Sign in to view email

Tsin Chien Yee Sally

R25127272

Recruit Express Pte Ltd

EA License No. 99C4599