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RA/QA/PV PHARMACIST [HJ1213-08]

Job title: RA/QA/PV PHARMACIST [HJ1213-08]
Location: Klang
Specialisation:
Salary: RM6,000 - RM8,000
Reference: PR/146753
Contact details: Jing May How
Contact email: jingmay.how@jac-recruitment.com
Job published: December 15, 2021 11:50
JOB RESPONSIBILITIES
  • Keep up to date with Malaysia national legislations and regulations that could impact the registration, marketing, promotion and distribution of pharmaceutical products in Malaysia.
  • Conduct regulatory assessment and develop regulatory submission strategies for new and current products in Malaysia.
  • Create and submit necessary applications to NPRA, respond to inquiries from NPRA, obtain and maintain approval.
  • Create and/or review artwork and labelling, ensuring that they are compliant with applicable regulatory requirements.
  • Conduct batch release / provide quality disposition for the distribution of products.
  • Assist with importation activities including custom clearance, trade affairs as the responsible pharmacist for the Company.
  • Conduct QA audits to relevant Business Partners.
  • Conduct PV employee training, i.e. reporting of individual case safety reports for the Company’s products.
  • Communicate and update Regional HQ’s PV and affiliates on any new PV requirements in Malaysia
  • Front PV audits from global PV auditors.
JOB REQUIREMENTS
  • Minimum Degree in Pharmacy, Pharmacist holding the Type A license (registered in Malaysia) is required.
  • At least 3-year experience in regulatory affairs for pharmaceutical products in Malaysia with some experience in submitting new chemical entities or new biological products in other regions outside Malaysia.
  • Experience in working with cross-functional teams with a good understanding of commercial activities in a pharmaceutical industry.
  • Good understanding of GMP, GDP and GVP requirements.
  • Positive attitude and able to work independently.