Support to hold relevant licenses for import/distribution of Amgen products in Malaysia.
Maintain and implement an effective Quality Management System that meets local Health Authority's requirements.
Management of wholesale and distribution activities of Amgen products in Malaysia.
Review and approving Quality records.
Ensuring that initial and continuous training programs are implemented and maintained.
Ensuring that customer complaints are dealt effectively according to Standard Operating Procedures.
Ensuring that suppliers and customers are legally approved or authorized to enable lawful supply of products.
Approving subcontract activities that may impact on Good Distribution Practice.
Keeping appropriate records of any delegated duties.
Deciding on the final product disposition.
Leads and participates in internal and external audit as needed.
Supports regulatory inspections or queries from Regulatory bodies.
Contactable by Authority by way of mobile phone number or an electronic mail address
Qualifications
Pharmacist Registration in Malaysia.
Hold a valid practicing certificate as Pharmacist in Malaysia.
In-depth knowledge and experience on Good Distribution Practice (GDP).
Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections.
Experience with Commercial Quality Operations and third-party management.
Experience with distribution models and/or establishment of new entity procedures a plus
