Report to : QA Executive
Duties and Responsibilities
- Fosters a strong and proactive collaboration with General Manager, Operations, warehouse, Client/Customer Services, IT, Finance/Credit and Business Development in terms of communication leading the development and compliance of Quality, Regulatory Affairs, Risk Management and Training related requirement, coordinates and enforces compliance and required compulsory yearly training and refresher courses.
-Maintenance of Quality and Regulatory requirements in accordance to the service scope contracted with existing and future Clients. All in accordance to the requirements of the industry by relevant regulatory agencies.
-Conducts presentation and meetings with potential Clients to provide a background on Quality, Regulatory Affairs and Risk Management 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.
-Assists QA Executive to ensure that the Company's Quality Management system at multiple sites are established and in accordance with GSDP.
-If a qualified Pharmacist, serves as the official and full time liaison personnel with the government's regulatory agencies.
-Compliance & Licensing management - Ensures company's operation are in compliance with all applicable government laws and regulations. Maintenance of the various licenses required to operate company's warehouse & distribution services as well as verification of relevant license from customers to sell controlled products.
-Pharmacovigilance management - ensuring contracts with Clients 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.
-Assists QA Executive by ensuring that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirement of the Marketing Authorized.
Key Result Areas
-Quality Assurance as per KPIs
- M.B.B.S or B.Pharm or Medical Related Degree
- At least 1 year of relevant experience (Consumer Health/Pharma products/Medical Devices and Diagnostics), with exposure to Quality management.
-Able to manage Quality, Regulatory, Risk management and Training requirements at Yangon and Mandalay.
-Exposure to Training and related expertise is an added advantage.
-In-depth knowledge of products and services with focus on Quality and regulatory Services.
-Knowledge of company operations and procedures, supply chain a plus.
-Negotiation and Influencing skills
-Good Command of English (Both verbal and written)
-System processes and IT skills , including good knowledge of SAP
-Self driven and goal Orientated
-Problem solver and positive attitude
-Has a sense of business acumen