Computer System Validation (CSV) Executive / Engineer
- Location
- Pan India
- Salary
- Not specified
- Company
- Akash pawar
Job description
• Role & Company / Project Overview: Swasti Solutions Private Limited is conducting immediate hiring for an experienced Computer System Validation (CSV) Professional (Executive / Engineer) for client projects across India (covering Gujarat, Madhya Pradesh, North India, and Mumbai). • Key Responsibilities & Daily Duties: - Plan, manage, and execute validation lifecycle activities across client sites - Perform hands-on Computer System Validation (CSV) activities - Prepare and manage comprehensive validation documentation, including Risk Assessment, URS (User Requirement Specification), FS (Functional Specification), and DS (Design Specification) - Author and execute qualification protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), as well as generate final Validation Reports - Utilize Validator or equivalent validation software tools - Ensure all systems comply with data integrity and regulatory standards • Required Qualifications, Skills & Experience: - Minimum 2 to 4 years of dedicated hands-on experience in Computer System Validation (CSV) - Strong technical understanding of CSV/Validation, PLC, and SCADA systems along with IQ, OQ, and PQ methodologies - In-depth knowledge of GxP, 21 CFR Part 11 regulations, Data Integrity principles, and global regulatory compliance requirements - Demonstrated ability to work on Validator or equivalent validation software - Strong documentation, technical writing, and communication skills - Freshers need not apply (experienced candidates only) • Working Hours, Shifts & Location Details: - Location: Pan India / Client locations across Gujarat, Madhya Pradesh, North India, and Mumbai - Joining: Immediate joiners preferred • Compensation & Benefits: - Standard company package based on experience and qualification • Application Instructions: - Interested candidates who can join immediately should forward their updated resume with 'CSV Experience' mentioned in the subject line.