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Closing Date: 30th July 2018
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Recruit Express Pte Ltd
Senior Regulatory and Compliance Specialist (Pharma MNC - 1 year contract)

Salary: 0.00

Compliance:

  • Support the audit preparation, coordination, and response follow up.
  • Follow up on Audit commitment and action closure with SMEs.
  • Manage the audit observation and closure through ICAMS and QRAMS.
  • Manage the Top 10 compliance risk.
  • Support Site Inspection readiness Program - prepare the package list - Inspection preparation plan , IPP, list of external and Top 10 compliance, GMP walk down, site presentation, Site Master File
  • Perform GMP Walk for QC, Manufacturing, Warehouse, Utilities and etc
  • Maintain GMP certificates and licensure documentation.

RA and Product submission:
  • Support the product submission for Licensure and new country submission
  • Support the review of FDA annual summary report 
  • Discuss and work with GRA and submission team to reply/response for new country submission.

Requirements 

  • Min Bachelor in Biotechnology, Chemistry, Pharmacy, Science, Engineering or equivalent.
  • At least 5 years of experience in Pharmaceutical or related manufacturing environment, in which at least 1 year is in QRC role.

Salary range: $5K to $7.5K 
Pharmaceutical MNC 


Interested candidates, please forward your resume to kevynhuang@recruitexpress.com.sg

Consultant: Huang JIngsheng Kevyn (R1333338) 





 
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