Regulatory Affairs Executive

2 days ago

Boon Lay, Singapore Private Advertiser Full time $80,000 - $120,000 per year

RESPONSIBILITIES:

  • Support the execution, monitoring, and continual improvement of the Company's Quality Management Systems in compliance with PIC/S GMP, cGMP, ISO:9001:2008 and any other relevant Quality Standards.
  • Coordinate and provide quality oversight for the conduct, report writing and closure of Complaints / Deviations / OOS investigations and their associated CAPA actions.
  • Provide quality oversight for the initiation, execution, report writing, follow up and closure of Change Control, Method / Process / Cleaning / Computer Validation Programs, and site wide Quality Risk Assessments.
  • Participate in the Suppliers Quality Management program, monitoring the performance and quality standards of approved Suppliers and Vendors.
  • Assist in developing, establishing, and monitoring the critical quality attributes, key processing, and testing parameters to ensure materials / products meet the prescribed requirements. This applies to both commercial products as well as product development projects.
  • Support the creation of Annual Product Quality Reviews.
  • Support the development and conduct of GMP Training programs.
  • Support the conduct of Quality Management Review meetings, including the generation of Quality metrics and trend analysis.
  • Support internal (ISO, GMP) and external (Health Authorities, Distributors) audits of HPH and its subsidiaries, including follow up CAPA actions.
  • Assist in the provision of technical documentation required for Product Registration Regulatory submissions.
  • Support the QA Batch Record review and Batch Release process.
  • Any other project / assignment that will be advised / directed by the direct supervisor.

REQUIREMENT:

  • Degree and above with a science background.
  • At least two years' experience in Quality (QA and/or QC) functions.
  • Experience in a cGMP healthcare industry is preferred.
  • Good communication and interpersonal skills, coupled with competent technical writing skills.
  • Team player with good analytical skills, and effective application of knowledge and experience

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