Overview

Amaris is looking for a Compliance Officer under a permanent position, in order to sustain its growth over Asia Pacific.

Responsibilities:

  • Compliance Officer is responsible to support the compliance team with the maintenance of the quality systems documentation. This position ensures the creation and revision of changes through validated system (e.g. Trackwise, SAP) and client’s shareholders following approved change control policies, process and procedures. Incumbent must maintain the highest level of compliance for the documentation.
  • Process requests for creation or changing of compliance documents following applicable policies, process and procedures (i.e. supplier’s program forms, regulatory records, etc.)
  • Support compliance specialist/supervisor in change control management, as needed.
  • Support compliance specialist/supervisor in internal/external audits scheduling & documentation preparation and regulatory audit preparation.
  • Support compliance specialist/supervisor in supplier re-qualification scheduling and complaints handling, as needed.
  • Actively lead and involved in setting up, tracking and drive the periodic review exercise of compliance activities/documents (e.g. Quality Agreements, Supplier Questionnaire, Audits).
  • Help on maintaining and monitoring Annual Product / Quality Review (APR and PQR) schedules until completion.
  • Track supplier and compliance area metrics as required.
  • Maintain, organize, scan and retain documentation in the compliance area.

Requirements:

  • Bachelor Degree in Sciences (e.g. Biology, Chemistry), Pharmacy, or Engineering
  • Knowledge of quality / compliance areas as well as regulations and standards affecting APIs and Biologics is desired but not required.
  • Minimum of 2+ years working on Documentation Control related areas in a Compliance (GxP) environment.

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