1 year contract QA Specialist - Pharma MNC
Recruit Express Pte Ltd| Date Posted: 28-Jun-2019
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Bachelor's / Honours
- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.
- Disposition the intermediates and active pharmaceutical ingredients (API).
- Work with supply chain and drug product sites to ensure timely delivery of quality products
- Participate in change control process with cross functional subject matter expert and ensure impact assessment is adequate and thorough.
- Review and approve cleaning records and procedures
- Improve quality assurance systems, as necessary.
- Review and approve deviations according to the site procedures. This includes participating with cross functional team in root cause analysis, performing the impact assessment with the subject matter experts for quality, validation and/ or regulatory impact, ensuring the adequacy of the associated corrective actions and/or preventive actions, reviewing and approving the investigation reports.
- Handle product complaints and 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 Record Reviews, discuss trends & atypical observations and recommend improvement actions.
- Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers/ service providers and collaborate with supplier to reduce starting material quality issues.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Participate/ lead continuous improvement project to improve work processes and quality system.
- Min Bachelor Degree in Science / Chemical Engineering or equivalent with relevant Quality Assurance experience.
- Familiar with the self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools.
- Previous Quality Assurance and GMP Compliance experience.
- Ensure compliance activities are carried out as per approved procedures and policies.
- Reviewing and approving change controls and deviation investigations.
- Reviewing and approving GMP documents.
- Manage GMP compliance systems e.g. QTS, PDOCS
Interested candidate please forward your resume to [Click Here to Email Your Resume]
Alternatively, you can call 6736 3280 to look for Jace Choo
Jace Choo Oi Kei
EA Personnel No: R1875164
EA License No.: 99C4599
Recruit Express Pte Ltd