Maintenance of Quality and Regulatory requirements in accordance to the service scope contracted with existing and future Principals. All in accordance to the requirements of the industry by regulatory agencies and the Ministry of Health.
Conducts presentations and meetings with potential Principals to provide a background on Quality, Regulatory Affairs and Trainings to assist in the securement of new business contracts and assist in the negotiation of various terms and conditions with regards to the Company’s service offering on warehousing and distribution.
Assumes the role of a Quality Management Representative in the ISO Committee to ensure that the Company’s Quality Management system at multiple sites are established and in accordance with ISO 9001:2008.
Serves as the official and full time liaison personnel with the government’s regulatory agencies and Ministry of Health. Represents the Company in Regulatory technical advisory board and PhAMA Regulatory Committee.
Compliance & licencing management - Ensures Company’s operations are in compliance with all applicable government laws and regulations. Maintenance of the various licences required to operate Company’s warehouse & distribution services as well as verification of relevant licenses from customers to sell controlled products.
Pharmacovigilance management – ensuring contracts with Principals are in accordance to services rendered, managing product complaints, adverse drug reporting (ADR) and overseeing regulatory aspect of product recalls.
Technical Advisory related to Regulatory for business improvements/developments.
Leads the Quality team to ensure that roles and responsibilities of the Quality team is carried out diligently at all sites meeting all of the Principal contracted Quality Agreements, Regulatory, GSDP, GDP and GMP’s requirements
Reviews the deviation reports to ensure that proper investigations, corrective / preventive actions are raised, agreed upon, implemented and strictly adhered to.
Leads and reviews the supplier audits to ensure that all new and existing suppliers are qualified in accordance to SOP, GSDP, GDP and GMP’s requirements as well as the Zuellig Pharma’s Code of Conduct.
Plans, reviews and implements the yearly Quality and Regulatory Affairs trainings for all the affected staff to ensure the companies high service standards and overall regulatory compliance is maintained at all times.
Responsible for the organisational structure, roles and day to day operation of the Quality, Regulatory Affairs and Training Departments.
Develops a high performing Quality and Regulatory Affairs service culture within the team and Company.
Plans, organises and directs an efficient and effective Quality, Regulatory Affairs and Training Department.
Develops, improves and set KPIs with individual direct reports and monitor individual performance.
Manages the allocation of appropriate resources and commitment of staff to the achievement of ZPM and Corporate Office objectives and targets.
Identifies training needs and coaching opportunities to develop highly skilled team.
5 years of relevant experience (Consumer Health / Pharma Products / Medical Devices and Diagnostics), with exposure to Quality and Regulatory Affairs at a senior management level.
Experience / exposure in dealing with Quality, Regulations & Enforcements within the laws of Malaysia for Pharmaceutical industry.
Able to lead a team compromising of Quality, Regulatory Affairs and Training.
In-depth knowledge of products and services, with focus on Quality and Regulatory Services
Experienced in Quality, Regulatory Affairs and Training.
Knowledge on regulatory and legal requirements.
Knowledge of company operations and procedures.
Able to manage Quality, Regulatory and Training requirements at multiple sites throughout Malaysia.
Exposure to Trainings and related expertise is an added advantage.
Established in 1922, Zuellig Pharma is the leading healthcare services provider in Asia with operations in 13 countries. The company provides targeted solutions including distribution of ...