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Internal Audit Regulatory Affairs

Location:
Roselle, IL
Salary:
35
Posted:
March 22, 2024

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Resume:

REENA KUMAR RESUME Page * of *

Reena Kumar

Pharmacologist 5+ Years Manufacturing/QA Research

https://www.linkedin.com/in/reenavirdi/ +1-630-***-**** ad4h1f@r.postjobfree.com Summary Master’s in pharmacology, with 5+ years of experience in pharmaceutical industry (QA, manufacturing), animal testing for drug efficiency, and research publication.

• Quality Management System: QMS

• Audit Compliance

• Drug Regulatory Affairs

• HVAC Validation at Manufacturing

• Trainings as per cGMP

• Handling Market complaints

• Packaging Artwork Approval

• Drug Stability Studies

• Self-Inspection/Internal Audit

• Preparation of APR (Annual Product Review)

Experience 2021-2023 Cosmas Research Lab Ltd. Ludhiana, India QA Executive

• Supervised IPQA team

• Supervised and controlled packaging activities by enforcing cGMP in shop and floor

• Prepared and reviewed SOPs and BMR

• Prepare BMR & BPR for anticancer products

• QMS and validation documents compliance

• To design the methodology and Review of Validation Protocols and Reports

(Process validation)

• Prepared protocol and plan for Drug Stability Study.

• Prepared Annual Product Reviews (APRs)

• Performed Internal audit (self-inspection) and external audit as per schedule/requirements

2018-2019 Overseas Healthcare Ltd. Ludhiana, India QA Executive

• Prepared and reviewed batch manufacturing record and batch packing record

• Prepared Standard Operating Procedures (SOPs)

• Checked/approved drug packaging artwork for labels, cartons, and foils 2016-2017 ACME Generics LLP Solan, India

QA/Documentation

• Created online documentation as per cGMP and SOPs

• Submitted daily quality report to the department head 2015-2016 Theon Pharma Ltd. Solan, India

Product Packaging

• Maintained QMS and validation documents compliance

• Coordinated with Production, QC, Warehouse, and Engineering departments Education May 2014 Master of Pharmacy

Guru Nanak Dev University, India

May 2011 Bachelor of Pharmacy

Government Polytechnic College for Girls, India

REENA KUMAR RESUME Page 2 of 2

Publications Indurthi, H. K., Virdi, Reena, Koli, P., Nageswara Rao, D., & Sharma, D. K. (2021). Seralite SRC-120 resin catalyzed synthesis of bis (indolyl) methanes using indoles and low/high boiling point carbonyl compounds under solvent free conditions. Synthetic Communications, 51(1), 139-150. https://doi.org/10.1080/00397911.2020.1849724

Koli, P., Reena, Mehra, R., & Sharma, D. K. (2020). Structure Activity Relationship of Indolylkojylmethane Based on Antiproliferative Activity against Breast Cancer. ChemistrySelect, 5(40), 12417–12420. Portico. https://doi.org/10.1002/slct.202003032 Koli, P., Reena, Indurthi, H. K., & Sharma, D. K. (2020). Anticancer activity of 3, 3 diindolylmethane and the molecular mechanism involved in various cancer cell lines. ChemistrySelect, 5(37), 11540- 11548. https://doi.org/10.1002/slct.202003137

Reena, Kaur, T., Kaur, A., Singh, M., Buttar, H. S., Pathak, D., & Singh, A. P. (2016). Mast cell stabilizers obviate high fat diet-induced renal dysfunction in rats. European journal of pharmacology, 777, 96– 103. https://doi.org/10.1016/j.ejphar.2016.02.066



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