GCP & Computer System Validation Auditor

Location: Mumbai; India
Department: Quality Assurance

We are Growing! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Job Responsibilities-

• Plans, conducts, documents, and reports GCP audits in accordance with applicable regulatory requirements, ICH GCP, company procedures, and approved audit plans.
• Conducts investigator site, vendor, process, Trial Master File (TMF), internal, and computerized system audits.
• Evaluates clinical trial activities and computerized systems for compliance with applicable regulatory requirements, quality standards, and approved procedures.
• Performs and documents reviews of software validation activities and deliverables to confirm alignment with approved requirements, applicable procedures, intended use, and risk-based validation principles.
• Drafts and maintains software validation documentation, including validation plans, risk assessments, and validation summary reports.
• Reviews supporting validation documentation, including user requirements, test protocols and scripts, traceability documentation, deviations, and objective evidence.
• Assesses computerized system controls related to electronic records and signatures, data integrity, user access, audit trails, backup and recovery, data migration, and system lifecycle management.
• Owns validation change control activities, including assessment of proposed changes, determination of validation impact, documentation of required actions, and verification of completion before closure.
• Plans, conducts, and documents periodic system validation checks to confirm that computerized systems remain in a validated state throughout the system lifecycle.
• Evaluates compliance with applicable computerized system requirements, including FDA 21 CFR Part 11 and EU Annex 11, as applicable.
• Identifies, documents, and communicates audit observations and compliance risks and reviews related Corrective and Preventive Action (CAPA) responses through closure.
• Supports sponsor audits and regulatory inspections by providing GCP auditing and computerized system validation expertise.
• Maintains audit documentation, reports, trackers, and supporting quality records in accordance with company procedures.
• Collaborates with functional areas to address audit observations, compliance risks, and quality improvement opportunities.
• Performs other Quality Assurance duties as assigned.

Additional Responsibilities-

• Provides guidance and training related to GCP auditing, computerized system validation, data integrity, and regulatory compliance.
• Supports quality risk assessments associated with new or modified computerized systems used in clinical research.
• Provides QA oversight and validation support for system implementation, upgrades, migrations, and retirement activities, as appropriate.
• Supports client interactions related to audits, GCP compliance, and computerized system validation.

Education-

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, Quality, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in the pharmaceutical, biotechnology, medical device, or CRO industry, including experience in Quality Assurance, GCP auditing, computer system validation, or a combination of these areas.
• Demonstrated experience conducting GCP audits in a regulated clinical research environment.
• Demonstrated experience performing documented software validation reviews and drafting validation plans, risk assessments, and validation summary reports.
• Experience owning validation change controls and conducting periodic system validation checks. Experience supporting sponsor audits and regulatory inspections preferred.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.