CSV Validation Specialist

3 days ago


Singapur, Singapore NO DEVIATION PTE. LTD. Full time
About the Role

No Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. We are seeking a highly skilled CSV Validation Specialist to join our team.

Key Responsibilities
  • Function as a Subject Matter Expert (SME) for CSV topics, providing guidance and support to ensure data integrity and compliance.
  • Develop and implement validation plans and protocols for CSV projects, including DeltaV.
  • Responsible for analyzing, identifying, and resolving issues that potentially impact validated status of computer systems.
  • Collaborate with the Quality Engineering Manager and Quality Organization to ensure compliance to cGMP standards and company policies.
  • Establish CSV project plans and execution plans for GMP computer systems, including DCS, PLC, BMS, MES, and eBR.
  • Generate, review, and execute protocols related to projects.
  • Work with teams to provide Quality Assurance oversight and ensure compliance to cGMP standards and company policies.
  • Maintain records to comply with Good Manufacturing Practice requirements.
  • Assist in the review and assessment of Change Requests and responses to CAPAs, particularly related to GMP computer systems.
Requirements
  • Bachelor's degree or a diploma of technical specialization, such as Engineering or Pharmacy.
  • 5 years of relevant work experience, with hands-on experience in the Validation life cycle of computer systems (DeltaV).
  • Experience in CSV activities in brownfield projects or operations support is a plus.
  • Good leadership and communication skills, with mentoring and coaching skills.
  • Excellent team player willing to work for the common goal.
About Us

No Deviation PTE. LTD. is a provider of patient-centric solutions for the pharmaceutical industry. We uphold our core values of Empathy, Integrity, and Transparency, and strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.



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