1 year contract QA Specialist (Compliance)

Recruit Express Pte Ltd| Date Posted: 12-Jul-2019
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent, Contract
Position Level:
Entry Level, Experienced
Qualification:
ITE/ NITEC/ Higher NITEC, Diploma, Bachelor's / Honours

Job Description

Job Respnsibilities:

  • Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and API to ensure batches produced are in compliance with PQS and regulatory registered specifications
  • Review and approve cleaning records and procedures and ensure compliance with PQS and guidelines.
  • Disposition the intermediates and API.
  • Review and approve GMP documentation and ensure their compliance to PQS.
  • Ensure adherence to quality procedures, regulatory requirements and cGMPs.
  • Improve quality assurance systems, as necessary.
  • Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the PQS
  • Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
  • Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
  • Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.

Job Requirements:

  • Previous Quality Assurance and GMP Compliance experience.
  • Bachelor Degree in Science / Chemical Engineering or equivalent 
  • Minimum 3–5 years’ experience in pharmaceutical GMP-regulated industries (Biotech preferred) and min 3 years’ thereof in Quality Assurance/Compliance roles 

Salary range: $4k to $5.5k

Interested candidates can forward your resume to this email: [Click Here to Email Your Resume]

Consultant: Huang Jingsheng Kevyn(R1333338)

Recruit Express Pte Ltd

99C4599

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Recruit Express Pte Ltd