Smart Medicine Sdn Bhd is looking for new potential candidates to fill in for Pharmacist position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
This position provides pharmacovigilance, regulatory and quality opportunities to ensure the Company’s GxP compliance to local health authority, and regulatory support for market access of innovative products and licence maintenance.
Be part of a dynamic Regulatory Affairs team, with responsibilities in the following areas:
Pharmacovigilance (PV) and Quality Assurance (QA)
- Responsible for the Company’s Quality Management System (QMS) to ensure local regulatory compliance and towards continuous improvement.
- Support in PV and safety related issues towards compliance and continuous improvement of GVP.
- Be the Company’s PV contact personnel with local health authority, and Principals.
- Responsible for PV and safety related issues, including execution of local RMP requirements.
- Responsible to provide and implement PV and/ or QA related consultation services to Principal(s) as engaged by the Company.
- Support in implementation and follow-up of internal and vendor audits. Participates in external audits from Principals or health authorities.
- Act as the responsible person for the Company to local health authority in relation to products and activities carried out by the Company.
- Maintain product license registrations and other licenses related to the regulatory compliance of the Company’s business in Malaysia.
- Management of local medical enquiries.
- Provide regulatory support services to Principals(s) where necessary as required by superior.
- Support in preparing and submitting product registration dossier and variation packages to regulatory authorities.
- Liaise with relevant authorities and Principal on registration and licensing related matters.
- Conduct related trainings to stakeholders on quality, PV, proper usage of products or other areas related to the scope of work.
- Any other tasks or areas as assigned by the superior or the management.
- Will have opportunities and exposure to various PV, RA and QA areas.
Qualifications and Skills:
- Candidates with the following qualification are preferred: Bachelor Degree in Pharmacy
- Preferably minimum 1 year experience in the Pharmaceutical industry
- Excellent writing and communication skills
- Systematic, driven, enthusiastic and resourceful
- Must be capable of working as part of a team as well as working independently with minimal supervision
- Proficient in Microsoft software including Word, PowerPoint and Excel
- Good interpersonal, analytical and organisational skills
- Positive attitude, meticulous with keen eye for details
If you are interested in discussing the above opportunity, please send your CV to HR officer by clicking Apply Now. We regret only shortlisted candidates will be notified.
Office/warehouse location: Subang Jaya
How To Apply
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