Prakash Jha

Corporate Quality Assurance professional with 12+ years of experience in sterile injectables (vials, ampoules, PFS) and OSD formulations, including end-to-end greenfield setup of a sterile injectable facility (Vadodara) and an OSD facility (Pithampur). Expertise in equipment qualification and validation (IQ/OQ/PQ), Computer System Validation (CSV), vendor audits, and risk management. Proven track record of ensuring compliance with global regulatory standards including US FDA, WHO, and ANVISA.

Strong problem-solving mindset with logical decision-making ability and a collaborative approach to driving quality, compliance, and continuous improvement.

Sr. Executive-CQA at Alembic Pharmaceuticals Ltd. (2024-04 – Present)

Managed Corporate Quality Assurance activities including Qualification, Validation, and Quality Management Systems (QMS)

• Led qualification and validation lifecycle (IQ, OQ, PQ) ensuring compliance with global regulatory standards such as US FDA, WHO, and EU GMP
• Ensured timely execution and closure of validation and QMS activities in line with project and regulatory timelines
• Collaborated effectively with cross-functional teams including Production, QC, and Engineering to achieve compliance objectives

Sr. Executive QA at Intas Pharmaceutical Pvt. (2022-12 – 2024-04)

Quality Assurance (Vendor Qualification and planning of internal Audit)

• Handling and managemnt of Vendor document
• Participated in team projects, demonstrating an ability to work collaboratively and effectively

Executive QA at Mepro Pharmaceuticals Pvt. Ltd. (2020-12 – 2022-11)

Greenfield Project Implementation and End-to-End Facility Setup

• New Plant Commissioning
• qualification and validation of New equipment quality acontrol and microbiological laboratory setup

Sr. Executive at Intas Pharmaceutical Pvt. (2017-04 – 2020-12)

Managed and executed qualification and validation activities (IQ, OQ, PQ) in compliance with GMP requirements

• Oversaw end-to-end validation lifecycle including protocol preparation, execution, and report approval
• Led qualification of critical equipment and utilities including HVAC, water systems, and sterilization equipment
• Managed aseptic process validation including media fill and sterilization validation
• Ensured data integrity and compliance during validation execution and documentation

Junior Officer at Macleods Pharmaceuticals Ltd. (2016-06 – 2017-04)

Executed IPQA functions including in-process checks, line clearance, and batch oversight to maintain GMP compliance

• Generated and verified COA ensuring accuracy, traceability, and compliance with approved specifications
• Contributed to successful project execution by supporting equipment and process qualification/validation activities

Junior Officer at IPCA Laboratories Ltd. (2014-12 – 2016-06)

Managed stability study activities including sample charging, withdrawal, and environmental monitoring as per approved protocols

• Oversaw analytical reports and ensured adherence to calibration schedules for laboratory instruments
• Supported internal audits by preparing and reviewing compliance documentation in line with GMP requirements

Bachelor of Pharmacy in Pharmacy – SPS, SOAU (2014-01)

Diploma in pharmacy – RCP (2010-01)

MBA in Operations Management – IGNOU (MBA) (2025-04)