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PAREKH INTEGRATED SERVICES PVT. LTD, Manesar

July 2022 - Present

Quality Executive

PISPL is a privately held 3PL company headquartered in Mumbai and having presence all over India. Parekh Integrated Services Private Limited is a pioneer in the field of Warehousing, Storage, Distribution and Supply Chain Solutions. The varied services including customized warehouse management systems, flexible point-to–point distribution solutions, complex end-to-end integrated logistics solutions and supply chain management. Clients include Pharma & RDTs manufacturers such as Roche, Qiagen, Abbot, Sebia, Cepheid and Mölnlycke. 

Roles and Responsibilities:

  • Handling customer complaints

  • Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification

  • Calibration and Preventive Maintenance

  • Customer audits, Regulatory audits and Internal audits

  • Validation of various corrugated boxes

  • Deviation, Non-Conformance and Planned Deviation

  • Temperature Mapping and Monitoring

  • Maintenance and documentation of all quality related records

  • Correction, Root Cause Analysis and CAPA

Astam Diagnostics

ASTAM DIAGNOSTICS Pvt. Ltd, Rajasthan

Mar 2021 - July 2022

QA Executive

Astam Diagnostics Pvt. Ltd. is a privately held company located at Bhiwadi, Rajasthan. Company is manufacturing Medical Devices (Thermometer/BP meter) and Rapid Diagnostic products (Lateral Flow Tests based on Immuno-chromatography). Currently working on Class B, C and D Rapid Diagnostics products such as HcG, Typhoid, Ovulation, Urocolour 2P, Malaria, HBsAg, HIV, HCV, and Syphilis products. Company has ISO:9001 and ISO:13485 certification.
Roles and Responsibilities:

  • Preparation and review of various technical documents such as SOP, DMF, Analytical Method Validation protocol, Standard Testing Procedure, BPRs and Batch Release Certificate

  • Preventive Maintenance 

  • IPQA

  • Performing Real Time stability and Accelerated stability as per schedule

  • Calibration lab equipment/instruments

  • Responsible for Sampling and Analysis of Raw material, Packing material, Finish product and In-Process Material and their Report Preparation

  • Review of artwork

  • Preparation and maintaining all lab related documents/log books

  • To ensure Good Laboratory Practices are followed at each level

  • Handling internal qualities audits and follow up the finding


Key Achievements :

  • Participated in ISO 13485:2016 audit for manufacturing license as per the norms leading to greater efficiency, productivity and improvement in various aspects of Medical Devices.

  • Participated in CDSCO audit for manufacturing license of Class - C and Class D rapid diagnostics test products (HBsAg, HIV, Syphilis, HCV, and Syphilis)​

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