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Regulatory Compliance Manager Jobs

Company

PT. Antarmitra Sembada

Address Jakarta Raya, Indonesia
Employment type FULL_TIME
Salary
Expires 2023-06-21
Posted at 11 months ago
Job Description

The candidate in this position will be responsible for all Good Distribution Practice activities - pharmaceuticals and medical equipment product. In addition to reporting to company management, BPOM and Ministry of Health, this candidate is responsible to enhance knowledge and operational capabilities in various functions within AMS to avoid CDOB violations

Responsibilities

  • Increase the number of activities carried out to enhance knowledge and operational capabilities in various functions within AMS to avoid CDOB violations and ensure compliance and/or understanding of SOPs.
  • Ensure that the follow-up actions on the results of the external examination/audit (BPOM and Ministry of Health) are completed within the specified time.
  • Minimize recurring findings in DC/Branch with findings on the same Major audit points.
  • Ensure that no DC/Branch of AMS is subjected to Temporary Suspension of Activities sanctions/warning sanctions due to CDOB/CDAKB violations.
  • Ensure that the follow-up actions on the results of the Compliance examination/audit are completed within the specified time.
  • Ensure that the Compliance audit is conducted according to the scheduled timeline until the final reporting.
  • Minimize audit findings from external parties (BPOM and Ministry of Health) regarding Critical and Major findings in DC/Branch of AMS.


Qualifications

  • Good knowledge about CDOB, CDAKB, CPAKB
  • Minimum requirement for this position : Pharmacist profession
  • Willing to travel across the country, branch visit
  • 4 years' of management experience on Pharmaceutical/ cosmetic/ medical equipment Distributor or manufactur
  • Placement : Jakarta Barat