CSV Validation Specialist
3 days ago
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.
- 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.
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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