Prafull Saurabh

QC - Auraya HealthCare Unit-II (A Unit of Higgs HealthCare Ltd)

(2024-10)

To ensure QMS related activities.
To ensure Method development and method validation of new Sterile Products.
To ensure the management of QC department daily activity including: in-process and lots release sample analysis, stability studies, and inspection and testing of finish goods.
To ensure Site quality control program supervisor, project management, and manage the quality control staff.
To ensure yearly Vendor audits for Packaging materials suppliers and raw materials suppliers.
Responsible for validation and process validation activities.
Responsible for preparation of validation / calibration schedule of instruments.
Responsible for overall cleaning validation activities.
Responsible for audits compliance.
Drug Approval in Chemical & Instrumentation.

QC - Zydus AHL (Division of Cadila Healthcare Limited) takeover Zoetis

(2016-02)

Analytical Method Validation of Sterile, Tablet and Liquid Oral as per ICH. To provide the Method validation data to IRA for filing.
Review the data of Analytical method validation & Analytical method Verification.
Method Modification as per Requirement.
Daily planning, Executing of Finish goods and Packaging Materials.
To ensure the tech transfer from PTC of Sterile, Tablet and Liquid Oral from research and Development site.
Handling of Lab Incident, OOS and deviation.
New Inspection plan in SAP
Handling of OOS, Deviation of finish goods and Packaging materials.
To ensure and review, method development for cleaning validation and cleaning verification of Liquid area, Tablet area and Injection Area.
Yearly Vendor audits for Packaging material suppliers.
Faced TGA, SFDA, audits 2019-2020.
To Ensure Cleaning validation activities of site, for solid dosage and sterile.
To ensure the method development for cleaning as per MACO.
To ensure the cleaning validation activity and yearly cleaning verification activity as per plan.

QC - Zoetis India Limited

(2014-12 - 2016-02)

Analytical Method Validation of Sterile, Tablet and Liquid Oral as per ICH. To provide the Method validation data to IRA for filing.
Review the data of Analytical method validation & Analytical method Verification.
Method Modification as per Requirement.
Daily planning, Executing of Finish goods and Packaging Materials.
To ensure the tech transfer from PTC of Sterile, Tablet and Liquid Oral from research and Development site.
Handling of Lab Incident, OOS and deviation.
New Inspection plan in SAP
Handling of OOS, Deviation of finish goods and Packaging materials.
To ensure and review, method development for cleaning validation and cleaning verification of Liquid area, Tablet area and Injection Area.
Yearly Vendor audits for Packaging material suppliers.
Faced TGA, SFDA, audits 2019-2020.
To Ensure Cleaning validation activities of site, for solid dosage and sterile.
To ensure the method development for cleaning as per MACO.
To ensure the cleaning validation activity and yearly cleaning verification activity as per plan.

QC - Jubilant Life Sciences - Roorkee

(2012-12 - 2014-11)

Analysis of stability sample and finish goods and raw materials samples.
HPLC Column Management
Data review of stability, finish goods and raw materials.
Method Modification of finish goods as per requirement.
Daily planning of stability samples.
Analytical Method transfer of, validation, and optimization of related substance, assay, Dissolution.
Handling of OOS, OOT and stability samples.
Faced USFDA and MHRA audits in 2012 - 2013

Analytical Chemist - Indswift Labs Limited - Mohali

(2010-04 - 2012-12)

Reaction Monitoring Of API
Planning, Executing and reporting of analytical method development of API.
HPLC Column Management
Method Development of Intermediated and Final API.
Method validation of Cation and Anion in final API.
Review of analytical data of Intermediate stage and final stage.
Calibration data management of Instrument.
Faced UFDA in 2013
Cleaning method develop of products. Claiming validation activities as per plan.

Analytical Chemist - Ranbaxy Labs Limited - Poanta sahib

(2007-07 - 2010-03)

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