ASSISTANT MANAGER - QUALITY ASSURANCE, LAB

at  Hartalega

Sepang, Selangor, Malaysia -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate11 Sep, 2024Not Specified11 Jun, 20245 year(s) or aboveIso Standards,Validation,Working Experience,Scheduling,Method Development,Operations Management,Iso,Reporting,Gmp,Root Cause AnalysisNoNo
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Description:

EDUCATION:

  • Bachelor’s Degree in Science or any related field.

WORK EXPERIENCE:

  • Minimum 5 years of working experience with similar roles and responsibilities in analytical testing laboratory preferably in chemical or medical devices industries.

TECHNICAL AND PROFESSIONAL KNOWLEDGE:

  • Sound knowledge in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Sound knowledge in FDA QSR requirements as per 21 CFR 820 and ISO Standards & requirements particularly ISO 13485, ISO 9001, and ISO 17025.
  • Strong knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA) and problem-solving techniques.
  • Strong knowledge of laboratory processes and operations management.
  • Project management principles, data analyses and reporting.
  • Work planning and scheduling; inclusive of operational and manpower planning.
  • Analytical method development and validation include test method development and test method validation.

Responsibilities:

REQUIREMENT SUMMARY

Min:5.0Max:10.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Science or any related field

Proficient

1

Sepang, Malaysia