Kingsforce Management Services Pte Ltd

Validation Specialist (Pharma)

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Job Description

Job Description:

Our client is a research and development-driven pharmaceutical company.
About the role:
  • Plan, Perform, and Coordinate Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator, etc.)
  • Clean Utility Validation in accordance with the Company’s internal procedures and industry standards. The qualification includes FAT, SAT, IQ, OQ, PQ of any additional/ modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers
  • Create, review and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications
  • Coordinate the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
  • Lead daily validation meetings with cross-functional in resolving validation issues
  • Experience in equipment qualification including analytical instrumentation and manufacturing equipment
  • Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
  • Be Knowledgeable about Data Integrity topics
  • Do regular progress report of project deliverables for Supervisor/ Project Lead
  • Carry out any other duties as assigned by the Supervisor/ Designated Person
About you:
  • Minimum of 5 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech
  • Experience to creates, Reviews, Approve computer system validation lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
  • Experience in coordinate cross functional (including local and global teams) for the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents
  • Experience in managing the qualification protocol execution process (cross functional), deviations management, and status reporting
  • Experience in leading daily validation meetings with cross functional in resolving validation issues.
  • Proficient in use of MS Office
  • Proficient in technical write up of validation lifecycle documentation (e.g. validation project plan, validation protocols, validation reports, validation discrepancies)
  • Proficient in application of risk assessment such as FMEA
  • Experience in computer system validation in qualifying process control systems.
  • Knowledge in recombinant processes under GMP environment

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Job Summary

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Entry level Bachelor's Degree, Post Graduate Diploma, Professional Degree
Kingsforce Management Services Pte Ltd

About

Established in 1994, Kingsforce Management Services is a specialist recruitment firm that focuses on the Oil & Gas, Construction, Pharmaceutical and Service Industry. In terms of functionality, we carry out senior hire mandates for sales, business development and finance verticals up to the regional CEO level.
Our Values: Empathy, Aspiration, Steadfastness and Forward-thinking.
Our Vision: Making recruitment and staffing effective and convenient for both employers and employees through humanised technology.
Our Mission: To be a recognised and well-respected brand that provides reliable and efficient recruitment services through our job portal for both employers and employees.

Learn more here: www.kingsforce.com.sg
Facebook: www.fb.com/kingsforcesg
LinkedIn: www.linkedin.com/company/kingsforcesg
 EA License No. 94C3545 

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