Bhavesh Savaliya

Professional with over 9 years of experience in Computer System Validation (CSV) within the pharmaceutical industry. Expertise in executing and managing validation activities for complex IT systems, ensuring data quality and regulatory compliance. Proven ability to uphold data integrity standards and align computerized systems with ALCOA+ principles.

• Responsible for preparation, execution and review of computer system validation deliverables (URS, IIA, VP, FS, CS, FRA, IQ, OQ, PQ test script, RTM, VSR, etc.) For new and enhanced systems of laboratory, Enterprise and manufacturing software
• Performing the spreadsheet validation for QC and cleaning validation
• Performing the periodic review of software’s based on the software criticality.
• Participate in risk assessment activity performed for computer systems, allocate mitigation plans accordingly, and ensure compliance.
• Working experience in QMS such as (Deviation, Change Control, CAPA and Investigation) for CSV/IT Compliance activity.
• Performed GAP Assessment of Laboratory software related to computer system validation document related GAPs with respect to current guideline.
• Windows Group Policy Implementation in instrument PC.
• Prepare and review of standard operating procedures related to information technology (IT) policies.
• Support during Audit and Audit Compliance Activities.
• Facing of Regulatory Audit like USFDA, TGA and Customer audits.
• Performed Audit of CSV service provider.
• Support & Review External vendor qualification documents.
• User Account Management Activities in QC/MFG Equipment/Instruments.
• Backup and restoration Activities in QC/MFG Equipment/Instruments.
• Preparation of GxP System inventory and periodic review scheduler as per SOP.
• Time Synchronization in QC/MFG Equipment/Instruments.
• Executed digital transformation strategy that modernized outdated systems, improving overall productivity.
• Developed and implemented quality assurance processes for IT projects.
• Led cross-functional teams to enhance software testing methodologies.
• Conducted regular audits on IT systems to ensure compliance with standards.
• Trained staff on best practices for quality management and risk assessment.
• Analyzed project documentation to ensure adherence to quality guidelines.

• Sun Pharmaceutical Industries Limited.(Halol)
• RAKS PHARMACEUTICAL Pvt. Ltd.(Dahej)
• E.I.D.-PARRY (INDIA) LIMITED (Tamil Nadu)
• Thermolab Scientific Equipments (Ahmedabad)
• Wockhardt Limited (Ankleshwar)
• Wockhardt Limited (Daman)
• Alembic pharmaceutical Limited (Panelav)
• Sterile-gene life science Pvt. Ltd. (Puducherry)
• Zydus Cadila Pharmaceutical Limited (Moraiya)
• Sun Pharmaceutical Industries Limited.(Dahej)
• Torrent pharmaceutical limited (Chhatral)
• Fourrts (India) Laboratory Pvt. Ltd. (Chennai)
• Cipla Pharmaceutical Limited (Sikkim)

• Date of Birth: 07/25/91
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• English
• Hindi
• Gujarati

• Travelling
• Watching Cricket
• Hearing Songs

• USFDA
• EMEA
• TGA
• WHO
• Customer & Consultant Audits (Lachman, Validant)