Quality Assurance Manager - Pharmaceutical

The Position

Maintain Quality system according to GDP and the corporate quality guideline to ensure good regulatory compliance to Law and Regulation applicable, and the implementation of quality policy and quality objectives. Conduct quality supervision and operation on business activities related to product quality, and ensure product quality, safety and quality process compliance in Hong Kong OPU.

Tasks & Responsibilities

Maintenance and implementation of the quality management system (KPI: Achieve the company quality objective)

• Responsible for/support the routine management and operation of batch disposition, satisfy product market supply in compliance.
• Responsible for Technical Complaint Management, acts as the local Management System Owner (l-MSO) for TPC's working with Global MSO in Corporate Quality, ensure all complaints received are recorded, proceeded, closed following the procedure with properly and timely manner.
• Responsible for/support the routine operation of product Change Control, Deviations, Events, and Complaints. Participate in relevant communications to ensure that quality-related businesses in compliance with regulatory and the company’s requirements.
• In the role of a Key User or Management System Owner (MSO), responsible for the management of related documents and collection of KPI/success indicators. In case of new user, responsible for corresponding training for new users, and participate in the regular communication and interactive.
• Lead the management of market actions and mock recalls for Hong Kong Market.
• Participate in and support the implementation of quality risk management with ROPU Quality.
• Lead the quality management reviews.

Discrepancy management (KPI: Deviations/CAPA created and closed to meet KPI targets)

• Local management system owner for Discrepancy Management system (Deviation/CAPA). Active partner with TCM Quality teams to implement all procedures to ensure compliance with Corporate requirements.
• Co-ordinates all Trackwise and Vault (or equivalent) software to ensure records are initiated, updated and closed per agreed timings.
• Manage Temperature and Logistical issues associated with the inbound deliveries and manage the Deviations in partnership with Supply Chain.

Supplier/3PL/Distributor management (KPI: Achieve the company quality objective)

• Support ROPU Quality and/or Local Supply Chain and participate in the management of suppliers, distributors and customers in Hong Kong, and participate in the communication and cooperation with suppliers, distributors and customers.
• Support ROPU Quality in the process of qualification of new suppliers, distributors.
• Responsible for/support the quality supervision associated with local suppliers includes but not limit to evaluation and review/approval on the company’s impacted changes, issues, etc.

Training and document management: (KPI: Achieve the company quality objective)

• Responsible for/support the routine operation of training management, and complete related training accordingly.
• As the coordinator and a key user of controlled document management system, responsible for/support the operation of GxP document life cycle management in system. Responsible for/support archiving and management of paper and electronic documents and providing training for new users accordingly.
• Responsible for/support managing the gap analysis of SOP and ensure that corporate regulations are implemented locally as required.

Requirements

• Bachelor's degree in pharmacy, bioscience or relevant discipline.
• Ability to correctly judge and ensure the implementation in quality management.
• Min 3 years’ experiences in Quality Management in Pharmaceutical industry.
• Have business/supply chain related quality management experience; Familiar with the relevant law and requirements of GSP/GDP
• Good competency in communication and collaboration. Strong leadership in teamwork & result Orientated.
• Strong Communication and inter-personal skills which allow efficient messages and clear engagement within the Network.

What you need to do now:

Click “Apply Now” if you are interested to be part of the team!

Alternatively, send your latest CV to Kalpana.charles@linksinternational.com for confidential discussion of your career!