We are currently seeking a QA Validation Engineer to support our client in Biopharmaceutical Industry.
Job Purpose:
Provide quality oversight in the area for Qualification and Validation in relation to Facilities, Utilities & Equipment (FUE) in BioProduction Operations Singapore. Quality systems need to be established and maintained in order to assure that all life-cycle documents derived from basic design and detail design, commissioning, qualification and validation of FUE adhere to cGMP rules and client's quality standards.
Key Responsibilities:
- Provide quality oversight (review and approval) establishment of User Requirement Specifications (URS), creation of Validation concepts, and establishing the Validation Master Plan (VMP) and Validation Plans (VP).
- Provide quality oversight and support in (review and approve) creation of qualification and validation documents e.g., GMP Risk Assessments, Design Specifications, Functional Specifications, Installation Qualification, Operational Qualification, Performance Qualification, including the respective protocols and reports, including supporting site discrepancies, deviations, investigation and closure in line with client's quality standard and site procedures.
- Act independently to create, implement, and maintain up-to-date site validation compliance program (e.g., access changes on validation impacts & etc.), strategy and provide the necessary training to develop site staff
- Actively participate as support in FAT and SAT and other regulatory inspections/ internal audits.
- Develop and implement site-wide Validation Plans and SOPs together with Validation Manager
Requirements
- Degree in Chemical Engineering or equivalent
- Minimum 3 years of experience in Pharmaceutical manufacturing or development (Biotech preferred)
- Minimum of 3 years in relevant Quality Assurance, compliance and Qualification/Validation
- Proven track record and practical experience in establishing and maintaining quality systems in labs equipment validation as well as successfully managing authority inspections from major Health Authorities
- Good communication skills, ability to work with cross-functional teams
- Must be comfortable with Contract basis role
