Quality Assurance Executive Operational Quality

2 weeks ago


Rawang, Selangor, Malaysia GoodScience Sdn Bhd Full time
1.

To report to Head of QA on any quality system matters related to compliance with PICS guidelines and pharmaceutical Quality system.


  • To promote GMP awareness and enforce practices in the operational area in order to ensure GMP compliance is met and in accordance to PICs requirement.
  • To advise on all the product quality aspects of GMP compliance and facilitating finished product release and access the quality impact.
  • To conduct routine walkthrough at operational area during the shift operation.
  • To review BMR/BPR to ensure completion and compliance prior forward to authorize person for final review and release.
  • To lead and conduct problem solving and investigation at site for any incident related to quality aspects.
  • To initiate and coordinate Product Quality Review program (PQR) on a yearly basis and arrange PQR review meeting with Head of QA and relevant personnel for improvement.
  • To lead and conduct product complaint investigation at site.
  • To coordinate in handling Finished Goods which are returned from distributor/customer to GoodScience.
  • To involve and assist in risk management at respective quality scope and area.
  • To assist in any external audit and provide post-inspection follow up information as requested.
  • To support and perform other QA Executive duties when he/she is absent or out of office.
  • Ensure adherence to company policies. To work as a team to achieve company objectives.
  • To carry out any other task assigned by Head of Quality Assurance and Deputy Director of Quality.

Requirements:

  • Degree in Chemistry, Chemical Engineering or Biology OR
  • Degree in Industrial Chemistry or any Science discipline


Relevant Experience :
  • A minimum 1 year working experience in Pharmaceutical Qualification/Validation activities.
  • To act as Quality Liaison Person at operational area (ensure GMP compliance, In-Process Quality Checks, involvement in Root Cause Analysis and Deviation Management)
  • Excellent verbal & written communication skills, knowledge of quality standard, able to work in team and attention to details.

Job Types:
Full-time, Permanent

Pay:
RM2, RM3,500.00 per month

Benefits:

  • Dental insurance
  • Free parking
  • Health insurance
  • Maternity leave
  • Opportunities for promotion
  • Professional development

Schedule:

  • Day shift
  • Monday to Friday
  • Rotational shift

Supplemental pay types:

  • Overtime pay


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