Company Description Compliance Compass Pharma is a specialist GxP consultancy that supports pharmaceutical, biotech, medical device, cosmetics, food, and nutraceutical organizations, including CDMOs and CMOs, in maintaining robust compliance. Many team members have prior experience as inspectors, which informs practical, inspection-ready solutions from single validation protocols to comprehensive readiness programs. The company provides training, auditing, validation, qualification, commissioning, and data integrity services aligned with global regulatory expectations, including US FDA, EMA, MHRA, ICH, WHO, PIC/S, CDSCO, GAMP 5, and ISO 14644. Its offerings also include advanced quality risk management using statistical methods, AI-assisted predictive quality analytics, and digital audit-trail forensics. Compliance Compass Pharma places vetted consultants on a project or interim basis, enabling clients to access specialized QA and validation expertise as needed. Job Title: Computer System Validation (CSV) Professional Company: Compliance Compass Pharma Consultancy (CC Pharma)

Location:
PAN India Employment Type: Contract

Experience:
2+ years Hiring Status: Urgent requirement

About the Role
CC Pharma is urgently hiring Computer System Validation (CSV) professionals on a contract basis across India. You will be responsible for validating computerized systems used in pharmaceutical operations, conducting remediation plan, and ensuring they meet regulatory and data integrity requirements.

Key Responsibilities
• Plan, prepare,



and execute validation activities for computerized systems across the full lifecycle
• Author and review validation documents such as URS, Validation Plan, Risk Assessment, IQ/OQ/PQ protocols, Requirement Traceability Matrix (RTM), and Validation Summary Report
• Perform risk assessments of GxP systems
• Conduct gap assessments of computerized systems against regulatory requirements and internal procedures
• Prepare remediation plans for identified gaps, and track them to timely closure
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) principles
• Support change control, deviation handling, and periodic review of validated systems
• Coordinate with QA, IT, and user departments during validation and audits
• Support internal audits and regulatory inspection Requirements
• Bachelor’s degree in Pharmacy, Science, Engineering, or a related field
• Minimum 2 years of hands-on experience in Computer System Validation in a pharma or life sciences environment
• Positive understanding of GxP regulations and the software development life cycle (SDLC)
• Strong documentation, communication, and analytical skills
• Ability to work independently and manage multiple validation projects Preferred
• Experience with systems such as LIMS, EDMS, QMS, ERP, MES, or lab instrument software
• Immediate joiners or short notice period

How to Apply
Send your updated resume to [email protected] with the subject line “CSV Application – Contract.”

📌 Computerised System Validation (India)
🏢 Compliance Compass Pharma
📍 India