SANDEEP KUMAR

Quality Assurance specialist

City Delhi NCR ady8yv@r.postjobfree.com Mobile Number +917********* https://www.linkedin.com/in/sandeep-kumar-21215051/ Career Summary

Kusum Healthcare 03/2022 – Current

Analytical Quality assurance Senior Executive

● Designed a comprehensive quality development plan for pharmaceutical aspects, meeting regulatory requirements (EU &MHRA) and ensuring product quality through final release.

● Streamlined management of caliber QMS, deviations, change controls, market complaints, incident, CAPA, OOS, OOT, Risk Assessment, and effectiveness by implementing a new tracking system that less resolution time by 40%.

● Executed internal and external audits for compliance with regulatory policies and regulations; delivered reports, which updated compliance status and identify suitable corrective actions, resulting in improvement in regulatory compliance.

● Reviewed analytical data, AMD, AMV, AMT, PDR, and Process Validation reports with quality Control team and R&D team; link gaps and facilitated the development and implementation of corrective and preventive actions which enhance Data quality and reduced customer complaints by 30%.

● Developed and delivered tailored training programs to over 50 users on the proper use of a proprietary data visualization tool; improved data accuracy by 25% and lessen reporting time by 30%.

● Coordinated cross-functional teams of Quality Control, Research and Production to ensure compliance with regulatory requirements; decreased product launch time by 30% and increased product quality by 20%

Mankind Pharma Ltd 03/2019- 02/2022

Corporate & Development Quality Assurance Senior Executive

● Established system audits, recognize gaps, and implemented corrective actions to achieve USFDA certification in Plant and R&D Centre.

● Site Representative for USFDA Audit and coordinate for related query response. To prepare, review and implementation standard operating procedure (SOPs) and quality guidelines.

● Managed caliber QMS, DMS& LIMS; reduced resolution time by 20% and improved effectiveness monitoring by 40%.

● Trained 100+ employees on updated standard operation procedures and various training module; increased process compliance by 50% and minimize errors by 30%.

● Performed audit compliance reviews for internal and external audits, updating compliance status with expert analysis and reporting, which decreases non-compliance risks by 45%.

● Reviewed and approval of many analytical development, validation & formulation development related data which insure the quality of designed product as per regulatory requirement.

● Enacted software CSV qualification (IQ, OQ, PQ) activities, ensuring software compliance and reducing compliance audit observations by 20%.

CIPLA LIMITED 07/2017 – 03/2019

Analytical Quality Control Senior Executive

● Quality management systems (QMS): handling Change Control requests, CAPA's, deviations, investigations, and Incidents.

● Involved analytical validation of methods, transfer and verification of different instrumental techniques, such as HPLC, GC, and UV.

PIRAMAL ENTERPRISES 12/2015 – 05/2017

Analytical Quality Control Executive

● Established validation of analytical methods, transfer & verification and routine analysis of FG, stability, and RM release related activities using by instrumental techniques, such as HPLC, GC, and UV. LUPIN LIMITED 12/2014 – 12/2015

Analytical Quality Control Executive

● Performed Analytical activity in FG & Method Transfer department, utilized HPLC, GC and UV techniques for analysis of solid and liquid doses. IND-SWIFT LABORARORY 05/2014 – 12/2014

Analytical Quality Control Officer

● Conducted analytical activity in the FG, Stability, and Raw Material & Packaging Material Section; utilized HPLC, GC and UV techniques for analysis of pharmaceutical OSD doses forms. AKUMS DRUGS & PHARMACEUTICALS 02/2013 – 05/2014

Analytical Quality Control Assistant officer

● Analyzed solid and liquid dose forms using HPLC, GC and UV techniques in Finish Good & Stability Section. Skills

• QMS Expertise • Internal & External audit Handling

• Audit Trail review • Analytical Data Review

• SOP Preparation • Analytical Method validation

• Audit compliance • Vendor Qualification

• Instrument Qualification • Data Integrity Handling

• AMD,AMT & PDR Review • Computer system validation RELEVANT PROJECTS

● Development of Caliber QMS, LIMS,DMS system:

o Developed caliber quality management System (QMS) and Document Management System (DMS) from scratch, dwindled document processing time by 50% by automating document review and approval workflows.

● Error Free Laboratory:

o Through investigations and trained users to overcome human error during analytical activities, reducing human error by 40% and achieving a 50% improvement in laboratory accuracy. EDUCATION

Master of Pharmacy (Pharmaceutics) 03/2012 (81.4%) Bhopal Institute of technology & science Pharmacy (RGPV Bhopal M.P). Bachelor of Pharmacy 06/2010 (65%)

Hygeia Institute of pharmaceutical sciences & research Center Lucknow U.P. SUMMARY

With a solid proven record of ten years in the pharmaceutical industry,works in different quality roles, including analytical quality assurance, development quality assurance, corporate quality assurance, and quality control. These diverse experiences have provided a comprehensive understanding of quality and compliance across different stages of the product lifecycle. Developed a demonstrated ability to contribute to the success of any organization by keeping the highest standards of quality and compliance.

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