Title:  Senior Manager Quality Assurance

Job Summary

Manage the quality assurance and collaborate with internal stakeholders to deliver sustained and continuously improving quality management system to meet all requirements as put forth in applicable regulations, guidelines, regional strategies and client requirements. Act as the MR for QMS.

Responsibilities include, but are not limited to:

• Ensure a quality management system is implemented and maintained.
• Focus on the management of authorized activities and the accuracy and quality of records.
• Approve continuous training program for all personnel involved in distribution activities.
• Coordinate and perform promptly any recall operations of healthcare and medical device products.
• Ensure relevant client and customer quality complaints are dealt with effectively.
• Review qualification and approval of suppliers/vendors (related to GxPs).
• Authorize return to saleable stock of any returned healthcare products (related to cold chain).
• Delegate duties when absent and keeping appropriate records relating to any delegation.
• Being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products.

General Responsibilities

Registered Pharmacist

• Responsible for supervising the discharge of psychotropic drugs.
• To assure the accurate management of PSY / PSE / DD inventory and required reporting on time
• To assure timely destruction schedule is carried out with engagement of Cawangan Penguatkuasa Farmasi Negeri.

Maintain and improve Quality Management System (QMS)

• Describe how the organization follows GxPs and operates to maintain a state of quality oversight control.
• Keep the QMS current with good industry practices.

Audit Compliance to Quality Management System (QMS)

• Audit for compliance to SOPs (ie on papers vs in practice)
• Report QMS metrics (ie KPIs), including trends that helps decision-making and taking proactive corrective/preventive actions.

Functional Skills and Knowledge

• Registered Pharmacist
• Trained in QMS
• Certified Lead Auditor for ISO9001 or ISO13485 will be an advantage

Education

• Bachelor's or Masters in Pharmacy 
• Minimum 10 years in a similar position at management level
• Experience in Pharmaceutical industry will be added advantage.