Affidavit

l, Chaitanya Mallireddy, do hereby solemnly state and affirm as here under:

1. I am over thirty-seven years of age and otherwise competent to make this
affidavit.
2. I am currently, and at all times relevant here to been, employed with Apotex
research PVT LTD, Plot No. 1 & 2, Bommasandra Indl Area, 4th Phase, Jigani Link
Road, Bangalore-560099.
3. During the period from 30/ 11/2015 to till date, I was employed with Apotex
research PVT LTD, Plot No. 1 & 2, Bommasandra Indl Area, 4th Phase, Jigani Link
Road, Bangalore-560099. In the capacity of Senior Executive in Quality Control
department.
4. From 11-Apr-2016 to till date, I was a co-worker of Mr. Challagundla Venkata Rao,
who worked for Apotex research PVT LTD, Plot No. 1 & 2, Bommasandra Indl Area,
4th Phase, Jigani Link Road, Bangalore-560099. In the capacity of Senior Executive in
Quality Control department, to my knowledge no less than 45 hours per week.
5. I certity that as a Senior Executive. Mr. Challagundla Venkata Rao to my knowledge
performed the following duties:
 Executing computerized system validation as per GAMP 5, 21 CFR Part11 as
well as associated regulatory guideline/requirement.
 Review of High-Level risk Assessment includes GxP Assessment and GAMP
categorization, criticality Assessment, ER/ES Applicability Assessment etc.
 Excellent experience as Validation Specialist and in-depth involvement in
writing test scripts for Installation Qualification (IQ), Operation Qualification
(OQ) and Performance Qualification (PQ).
 Experienced in Periodic review to confirm that the computerized system
remains in a valid state and are compliant with regulatory and standard
requirements.
 Expertise in applying quality management tools, conducting internal audits in
compliance with global skilled in formulating and maintaining research
objectives complementary to corporate policies/ customer demands.
 Demonstrated excellence in Quality Risk Management, utilizing risk
assessment tools such as FMEA and HACCP to identify potential risks and
implement effective mitigation strategies, ensuring product quality and safety.
 Skilled in Manual Testing, Smoke Testing & Regression Testing and Localization
Testing (Chinese, Japanese and Korean) processes as per ISO 9001: 2000 and
CMMI Level 5 requirements.
 Expertise in Test Strategies, Test Scripts, Test Cases, Test plans, Test
procedures, Test requirements and testing standards.
 Affidavit

 Experience in Software Development Life Cycle (SDLC), Like Waterfall, V-

Model, and Agile methodology.
 Experienced in Periodic review to confirm that the computerized system
remains in a valid state and are compliant with regulatory and standard
requirements.
 Expertise in Validation of PLC, DCS and SCADA control systems.
 Performing factory/site acceptance testing (FAT/SAT).
 Review of Data Migration Plan, System Retirement Plan with summary Report.
 Knowledge of GxP, FDA, EU and other relevant regulatory requirements for
Pharma, and Biotech.
 Involved in the Software development life cycle (SDLC) and Computer System
Validation (CSV) life cycle.

I certify that the foregoing statements made by me are true. I am aware that if any of
the foregoing statements made by are willing false, I am subject to punishment.

Dated: 14.09.2023 Chaitanya Mallireddy

Subscribed and sworn to before me this 14th Day of September 2023.