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Senior Validation and Compliance Specialist
Job post no longer accepts applications
CUTE SOLUTIONS & SERVICES PTE. LTD.
SingaporeLocation
Singapore
20 days ago
Posted date
20 days ago
N/A
Minimum level
N/A
Contract / Freelance / Self-employedEmployment type
Contract / Freelance / Self-employed
OtherJob category
Other
Responsibilities:
  • Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
  • Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
  • Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
  • Assist in review and preparation of process/production equipment validation and computer systems validation
  • Review and approval of all Data Integrity - related activities and training including periodic reviews and status report to management
  • Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
  • Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
  • Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
  • Hands on Computerized Systems Validation GAMP5/21CFR

Requirements:
  • Minimum 8 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
  • Minimum bachelor's or master's degree
  • Preferred Six Sigma black and green belt certified as it is mandatory for the project prerequisite.
  • GMP & GDP Certificate is mandatory
  • Well versed with Regulatory Guidelines - USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP , GAMP5, ISO, WHO etc.
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JOB SUMMARY
Senior Validation and Compliance Specialist
CUTE SOLUTIONS & SERVICES PTE. LTD.
Singapore
20 days ago
N/A
Contract / Freelance / Self-employed
Job post no longer accepts applications
Senior Validation and Compliance Specialist
Job post no longer accepts applications