(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 [email protected]

Tsin Chien Yee Sally
R25127272
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