Satendra Kumar

Assistant Manager – Quality Assurance

Kāla Āmb, SirmaurMember since January 22, 2026

cGMP complianceProcess validationDocumentation controlRegulatory adherenceCross-functional coordinationSAP SoftwareMarg software

About

Total Experience: 11.6 years.

Domain Expertise: Quality Assurance (Pharmaceuticals, Parenterals, Cosmetic Personal Care and Aerosol-Deo and Topical Spray).

Core Strengths: cGMP compliance, process validation, documentation control, regulatory adherence, and cross-functional coordination.

Objective: To pursue a career where I could continuously learn and develop my skills for Organizational as well as Personal development at work.

Notice period: 01 months.

QA Officer - AXA PARENTERALS LTD. - Roorkee, Uttarakhand

(2014-06 - 2017-12)

In process verification (IPQA) in Dispensing, Manufacturing and packing & implementation of SOPs (General, cleaning, Operations).
To verify the Line clearance at all stages from Dispensing to Dispatch as per SOP.
To verify the online Documentation.
Preparation & Revision of Master Batch Manufacturing records.
Preparation of Process Validation Protocol & Report.
Preparation & Revision of Standard operating procedure (SOP).
To ensure the validation process superheated water spray sterilizer autoclave, HPHV Autoclave, HVAC, bubble point integrity machine, Vacuum leak test machine& FFS machine.

Sr. QA Officer - Relax Pharmaceuticals Pvt. Ltd. (A Group of Mankind) - Paonta Sahib, Distt-Sirmour (H.P.)

(2017-12 - 2019-12)

Preparation of Annual Product Quality Review(APQR).
Review and Preparation of BMR & BPR.
Control Sample Management.
To verify the Calibration of Balances, IPQA Instruments.
Involved the Artwork Development, Revision & Shade cards approval at final stage.
To check and review all Analysis worksheets & Quality Control Data at Bulk stage/Semi finished/finished stage.

Assistant Manager - Sai corporation private limited (A Group of One Asia) - Kalaamb, distt- sirmour (H.P.)

(2020-01 - 2024-11)

To handling of marg software i.e. new bom create PM & RM, item create, inventory check, FG transfer etc.
To handling SAP Software B1 version 9.2.
To handling change control, incident and deviation.
To handling stereo indent process batch to batch.
To verify the Packing Materials specification and COA requirements.
To ensure the follow up Stability studies for 1st Batch of the year.
To ensure purified water testing i.e. chemical as well microbiological.

Assistant Manager - Stella Indusstries private limited - Gurugram

(2024-11)

To Ensure the Batch release as per Product release Specification & COA.
Review the BMR, COA, analysis worksheet and other related Documents.
To ensure the cGMP Compliance &personal hygiene.
Daily track activity at mfg. sites for Quality Issues.
Check stereo impression & Maintain record.
Handling MSDS Sheet required material storage condition.
AQL Limit and training record maintain.
PQRS data update in party portal link.
Handling of Nivea FFPR updated in software any new formulation introduce in system.