Quality Assurance & Regulatory Affairs Executive

Puchong, Selangor, Malaysia

Job Description


  • Candidate which possess Bachelor Degree in Science eg. Biotechnology, Biomedical, Chemistry, Biology, Pharmacology or equivalent.
  • 2-3 years of working experience in regulatory affairs from veterinary healthcare / pharmaceutical industries.
  • Familiar with product registration system from relevant authorities.
  • Good spoken and written communication skills in English and Bahasa Malaysia.
  • Able to work independently, good time management skill, well-organized, positive working attitudes, teamwork spirit and great attention to detail.
Responsibilities
  • To review product registration dossiers, labelling & marketing materials to ensure compliance with relevant regulatory requirements.
  • To ensure on time submission and to monitor the approval status for product registrations, variation and license applications with relevant regulatory authorities for group of companies.
  • To manage authorities\' queries and on-time feedback.
  • To ensure maintenance of all registration files and licenses.
  • To liaise with suppliers to collate the information and details for product registration.
  • To keep abreast of current legislations, standards and guidance documents.
  • To collaborate with Customer Service Department on the compilation of signed Poison Signed Orders and Prescription Forms.
  • To perform daily incoming goods inspection.
  • To ensure all the GDP SOPs and forms are up-to-date and maintain the current version in the GDP file.
  • To conduct quality and GDP training to staff.
  • To support, participate and follow-up on external and internal audit and audit report/deviation report.
Benefits
  • Insurance and EPF contribution
  • Friendly and energetic working environment
  • Outstanding career growth and development
Additional Benefits
  • Annual Leave
  • Medical and Hospitalisation Leave
  • EPF / SOCSO / PCB
  • Medical Insurance
  • Training Provided
  • 5 Working Days

Ricebowl

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Job Detail

  • Job Id
    JD964824
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Puchong, Selangor, Malaysia
  • Education
    Not mentioned