Business Edge Personnel Services Pte Ltd

Regulatory Specialist/Executive - Temp

Business Edge Personnel Services Pte Ltd| Date Posted: 14-Nov-2019
EA Licence No: 96C4864|EA Personal Registration No: 199606466D
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

This is more towards administrative support to cover for maternity, period of 6months. Can also consider fresh degree graduate. Salary per month: Range between $2500 - $3000 (depending on qualification and relevant experience if any) Open for Fresh graduate.

Regulatory Specialist/ Regulatory Executive - Temp

Department/Branch: Health Products Regulation Group (HPRG) - Audit Branch (AB)/ Licensing & Certification Branch (LCB)

Duration: 6months / Immediate to Mar 2020

Responsibilities

  1. Evaluate documentary GMP Documentary Evidence Verification Applications(DEVA)
  2. Evaluate licence applications for import/export/wholesale of controlled drugs and psychotropic substances, and applications for import of personal medication
  3. Liaise with other HPRG Branches and other overseas Regulatory Authorities in the processing of applications of DEVA, Overseas GMP audit and licence applications
  4. Assist to manage and handle technical and procedural enquiries (telephone calls, e-mails, fax messages, CRM, and walk-in clients) on applications
  5. Assist the effective implementation of the ALD Quality Management System in accordance with PIC/S QS and ISO:9001 standards
  6. Assist in performing enhancements to existing and new processing systems including associated URS, UAT, etc.
  7. Assist in monitoring and collation of statistics related to scope of work undertaken
  8. Perform such other duties as LCB and AB may reasonably require

Requirements

  • Minimum degree holder, preferably a Bachelor in Pharmacy / related Pharmaceutical Sciences; or related science disciplines with knowledge in pharmacology, toxicology, chemistry, chemical engineering, biochemistry, microbiology.  Open for Fresh graduate.
  • Preferably with at least 3 years industrial pharmaceutical manufacturing experience and/or quality assurance / control in the pharmaceutical or biopharmaceutical industry, with good understanding in manufacture of non-sterile and/or sterile medicinal products
  • Preferably have experiences in knowledge on international GMP standards and quality management systems (e.g. ISO lead auditor)
Company Overview
Business Edge Personnel Services Pte Ltd