Harsha Bhole

A highly skilled and detail-oriented around 6 years of experience in Pharmaceuticals and biologics field. Specialization in Computerized System Validation, Regulatory compliance, Quality Management system and R&D (Analytical Research & Development). Demonstrates comprehensive expertise in validating GxP-regulated computerized systems in alignment with global regulatory guidelines- GxP, FDA, USFDA, 21 CFR Part 11, EU Annex 11, WHO, GAMP 5, MHRA and ALCOA+++ principles of data integrity.

Possesses a strong foundation in quality systems, risk-based validation strategies, validation lifecycle, reviewing critical documentation, quality audits, CAPA management and SOP development. Adept at managing complex validation projects, conducting gap assessments, compliance review, deviation handling and implementing remediation plans for legacy systems. Collaborating with cross-functional teams to ensure compliance and continuous improvement in computerized systems.

Validation Consultant at Infosys Pvt Ltd (2025-02 – Present)

Received Certificate of Appreciation from Lupin for outstanding contribution to SAP S/4 HANA IMPLEMENTATION 2023.

• Managed and reviewed multiple validation project simultaneously to ensure timely delivery and meeting client requirement.
• Preparing, Execution, Reviewing & Maintaining validation deliverables such as User requirement specification, Functional requirement specification, Functional risk assessment, Design & Configuration specification, IQ, OQ, PQ, Validation Project plan, Validation Protocol, Validation summary report, Vendor audit checklist. To track and review of the documents such as audit trail of a computerized system, user access review, backup and restoration and ensure that activity is completed by the CSV or IT team as per the defined frequency.
• Facilitate approval of validation documents after review and ensure availability of CSV documents (Physical & Scan) whenever required by Lupin during audits.
• Assist the Lupin IT CSV Team and it's Vendor's in making CSV documents in line with cGMP guidelines.
• Prepare /Update and review SOPs, Templates and Work Instructions (WI)
• Provide assistance in the internal audits and Gap Analysis on existing and new computer software system applications.
• Provide training on computer software system validation to IT consultants.
• Assign document no. to QRM, URS, FRS, FRA, DCS, VPP, VP, IQ, OQ, PQ, CVC, VSR, LED, SRC & VAC.
• Track Change control, Deviation record & QRM for closure & update list.
• Ensured all validation activities complied with global regulatory standards ( FDA 21 CFR, Part 11, EU Annex 11, GAMP 5 and align with SOPs.
• Assist in SAP S/4 HANA implementation activities, supported SAP roll out for multiple sites & supported on end to end P2P process.
• Software handled DMS, QMS, EDMS, SABA, LIMS, Chromeleon and come across to Software SAP, PTD, AMS, Cleen, Automation Anywhere 360, Veeva Vault.
• Coordinate with Lupin's vendor in completing the vendor or supplier assessment activity.
• Conducted Veeva Vault supplier assessment and system compliance.
• Reviewed Veeva validation packages (Quality Doc, QMS & Training), release notes and impact assessments.
• Developed & Reviewed Veeva Vault SOP's.

CSV Officer at Meyer Organics Private Limited (2023-02 – 2025-01)

• Preparing and Executing validation Deliverables such as QRM, URS, FRS, FRA, DCS, VPP VP, IQ, OQ, PQ, CVC, VSR, LED, SRC & VAC for new and existing computerized systems in accordance with regulatory requirements and internal procedures.
• Assisted in validation activities for GxP-regulated systems.
• Participated in internal audits and maintained audit-ready documentation.
• Supported risk assessments and change control process.
• Ensured compliance with 21 CFR Part 11 and Annex 11 requirements.
• Coordinate with validation team members and track requirement clarifications.

ADL Officer at Meyer Organics Private Limited (2020-10 – 2022-11)

• Performing method development for various products & raw material.
• Performing method validation of robust analytical method as per regulatory compliance.
• Preparing validation protocols, reports and summaries along with monitoring and execution of the validation activities as per protocols.
• Calibrated & Performed test using Karl Fisher.
• Performing Assay, RS, Dissolution, CU of R & D trial samples & stability samples.
• Performing raw material test as per COA.
• Performing calibration of HPLC, UV & Dissolution (Type I, II & III) as per SOP.
• Hands on experience on HPLC software (Chromeleon, Empower & Chemstation).
• IPQC equipment's (Disintegration apparatus, Hardness Tester, Friabilator, Refractometer etc.)
• Hands on experience on FTIR, Melting point.
• Mentoring and train junior, fostering a culture of continuous learning and improvement.
• Efficiently worked with all associated technology and software applications for sample analysis.
• Troubleshooting complex analytical issues and develop innovative solutions to advance project goals.
• Good Knowledge on 21 CFR Part 11, EU Annex-11, GDP, GLP, ICH and GAMP 5.
• Handling LIMS on day to day basis.

Trainee Executive Research Associate at Perrigo Laboratories India Private Limited (2019-10 – 2020-10)

• To perform daily calibration of pH & analytical balance.
• To perform calibration of Biosafety Cabinet.
• To perform Assay, CU, Dissolution and RS of R&D Trial samples & Stability samples as per pharmacopeia & in house method.
• To perform Blend uniformity of R&D trial samples as per pharmacopeia & in house method.
• To perform water content of R&D Trial samples.
• To perform particle size analysis of R&D Trial samples.

Master of pharmacy in Pharmacy – Dr. L. H. Hiranandani college of Pharmacy, Ulhasnagar (2019)

Bachelor of pharmacy in Pharmacy – Dr. L. H. Hiranandani college of Pharmacy, Ulhasnagar (2017)

H S C – M.P Board (2013)

S. S. C – M.P Board (2011)