Quality Compliance Assistant

2 weeks ago


Nusajaya, Malaysia Owen Mumford Sdn Bhd Full time
Prepare and collate required documentation to support submissions for product approval and maintenance (e.g. Variations to Marketing Authorisations, MDA etc)

  • Maintain efficient scheduling of regulatory licenses maintenance and renewals and support Competent Authority audits to the licences.
  • Support the timely registration of all current and new products with the correct regulatory authorities.
  • Responsible for advising/supporting internal SMEs to assure the continued Regulatory Compliance of existing products throughout their life cycle
  • Review proposed marketing materials, packaging, Instructions For Use and Label copy for Regulatory compliance to MDA and to the appropriate requirements for ROW markets.
  • Setup packaging labels for Owen Mumford Sdn. Bhd, ensuring the labels comply to the appropriate labelling requirements for relevant markets.
  • Maintain the electronic product packaging artwork folder to ensure it is always up to date and organized.
  • Maintain effective and efficient administration of Change Control for Owen Mumford Sdn. Bhd.
  • Maintain good documentation filing system of Design Transfer Files for products/projects that are being transferred from Owen Mumford Limited.
  • Any other activity as directed by the Regulatory Affairs Officer or Site Quality Manager.
  • Report to Regulatory Affairs Officer on progress with activities, provision of metrics and other information (e.g. input to Weekly /Monthly Quality / RA Reports) and escalation of issues.
  • Comply with Owen Mumford policies and procedures and fulfil roles and responsibilities as defined to support full compliance.
  • Complete work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed.
  • Listen to performance feedback provided and takes any necessary improvement action.
  • Complete personal Training and Development Plan and seek opportunities to grow and learn.

Benefits:

  • Dental insurance
  • Health insurance
  • Parental leave
  • Professional development

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Performance bonus


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