Prestige Biopharma Pte Ltd

Quality Assurance Manager

Prestige Biopharma Pte Ltd| Date Posted: 7-Sep-2019
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Job Nature:
Permanent
Position Level:
Manager
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

We are looking for an QA Manager or Executive to join lab and to support all GLP-related preclinical and clinical assays in the facility.  

Primary duties and responsibilities

  1. Awareness of EMA, FDA, OECD GLP guidelines and any other related regulations
  2. Establishment of Quality Management System based on ISO 17025 standard in a bio analytical and bioassay testing laboratory
  3. Conducts audits of studies, facilities and processes for compliance to relevant regulations and guidelines and report to Study Directors and Management
  4. Review SOPs and assist in writing Quality Assurance SOPs
  5. Conduct training for staff with emphasis on GLP and other related regulations
  6. Host regulatory inspections and follow up with national international regulatory agencies as required

Skills

  1. Knowledge of commonly used terminology, concepts and practices within QA field
  2. Work well with numbers and staff
  3. Team player, detail oriented and highly organized
  4. Effective oral and written communication skill
  5. Basic computer skills

Requirements:

  • Qualifications: Bachelor degree
  • Prior experience as Quality assurance in GLP facility and QA experience in clinical CRO is a plus
  • Only Singaporean and PRs
Company Overview
Prestige Biopharma Pte Ltd