Regulatory Pharmacist

Singapore, Singapore

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MAIN FUNCTIONS:

Form A license holder and other license as required by regulatory.
Liaise with regulatory body regarding pharmaceutical compliance affair.
To update local and overseas countries on regulatory requirement for implementation.
Involved in day-to-day pharmaceutical manufacturing operations and ensure compliance to PIC/S GMP standard.

RESPONSIBILITIES:

To assist in maintenance of product license with local and overseas authority.
To prepare product registration dossier for local and overseas market.
To assist in regulatory audits and response to the authority query.
To assist post-marketing product query or correspondence and work closely with QA/QC department pertaining to product quality issue.
Responsible for all dispensing materials and activities to use in production.
Maintenance of controlled drugs and records, including the storage and sale.
Review and update SOP relating to the production periodically.
Handling and managing of production issue raised by the production team.
Provide training to production staff on SOP and cGMP.
Work closely with QA/QC department to maintain cGMP standard.
Be involved in other company projects.

REQUIREMENTS:

Candidate must possess at least Bachelor\'s Degree of Science (Pharmacy).
At least 2 Year(s) of working experience in the related field is required for this position.

OTHER INFORMATION:

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