1 year contract Validation Engineer - PHARMA MANUFACTURING MNC

Recruit Express Pte Ltd| Date Posted: 16-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Position Level:
Diploma, Bachelor's / Honours

Job Description

Essential Duties & Responsibilities

  • Provide guidance on planning and execution of validation projects for IFC manufacturing equipment, processes and facilities
  • Lead development of validation strategies and guide validation planning
  • Work with cross-functional teams on preparation and execution of validation activities
  • Review validation protocols and reports; provide QA support
  • Manage IFC quality engineering and lead / participate in investigation and implementation of corrective and preventive actions for customer complaints and non-conforming products, and follow up on proper closure with verification of effectiveness.
  • Collaborate with HQ, Tech Support and cross functional teams on customer complaints and respond to inquiries as needed.
  • Ensure proper documentation of customer feedback and analyse failure trends to identify improvement actions.
  • Manage records and tracking of reports from quality sub-systems such as Non-Conformance Request (NCR), Corrective Action (CA), and Preventive Action (PA) and ensure timely closure.
  • Analyze quality monitoring data, trend performance, and prepare reports to communicate results of quality assurance activities.

Minimum Qualifications

  • Bachelor’s Degree in Engineering, Science, Biotechnology or related fields.
  • 5+ years’ experience in validation and QA in medical device manufacturing.
  • Thorough knowledge and understanding of ISO 13485 and cGMP/QSR, validation principles, and applicable regulations related to validation principles.
  • Drive, initiative, resourcefulness and analytical skills together with a customer-focus attitude.
  • Team player with strong communication and interpersonal skills and ability to lead, organize and influence others in accomplishing tasks.
  • Certified internal auditor in ISO 13485

Interested candidates please submit your resume to [Click Here to Email Your Resume]

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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