Quality Assurance Manager (Pharmaceutical/ Healthcare, Office Hours 5 Days)

Recruit Express Pte Ltd| Date Posted: 14-Mar-2020
EA Licence No: 99C4599|EA Personal Registration No: R1551708
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

Key Responsibilities

  • Serve as the main Quality point of contact related to suppliers
  • Manage External site to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements
  • Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
  • Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
  • Provide quality oversight of the manufacturing, testing, and release of materials at External site
  • Author and drive actionable site inspection readiness plans
  • Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
  • Representation at product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
  • Identify and mitigate risk at the External site
  • Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
  • Escalate risks or roadblocks to management
  • Drive timely decision making using principles
  • Drive continuous improvements

 

Requirements:


• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents

• Min 5 years relevant experience in a related industry preferred

• Able to start immediately preferred


If you are interested in any of the positions, do kindly drop your most updated resume to [Click Here to Email Your Resume]   (Attn: QA Manager- Leon)



Thank You.


Leon Leong De Cong


R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)


EA License: 99C4599

Company Overview
Recruit Express Pte Ltd