Technical Skills

QC Systems and
Assistant Manager Compliance
Software (21CFR,
Waters, Chromeleon,
Phone : LIMS, Tiamo, Lab
Email ID : Solutions, SAP)
Address : Instrumentation
Date of Birth: (HPLC, UPLC, GC,
Malvern Particle Size
Analyzer, UV, FTIR,
KF, Autotitrator,
Dissolution)
Dedicated and knowledgeable professional with over 18 years of experience in the Quality Control
department of the Pharmaceutical industry, I am passionate about ensuring product quality and safety. Various Kinds of
Versatile in Quality Control techniques, Quality Management System documentation, and regulatory Validation (Method,
compliance, I am adept at balancing strict compliance requirements with operational efficiency. I am Process, Cleaning)
seeking a role where I can apply my skills in planning, execution, method validation, and more, and
contribute to improving and upholding the overall product quality standards of a renowned Soft Skills
organization.
Leadership
Professional Summary Team Management
Problem Solving
18+ years of extensive and progressive experience in Quality Control with a focus on method
validation, verification, transfer, process validation, finished products, raw materials and non-
routine.
Core Competencies
Currently working as an Assistant Manager in Quality Control at Encube Ethicals Pvt Ltd, leading Quality Control and Assurance
stability section with a team size of 20 persons, ensuring efficiency and productivity. Regulatory Compliance
Adept at QMS documentation including initiation and investigation of Laboratory Change Control, Audit Management
OOS, OOT, Laboratory incidences, Out of Calibration, Deviation and implementation of CAPA.
Proficient with a wide array of QC instruments such as HPLC, UPLC, GC, and experienced with 21CFR Education
compliance software i.e. Waters, Chromeleon, LIMS, Tiamo, Lab Solutions, SAP .
Hands-on experience handling multiple dosage forms like Tablets, Topical Preparations, and Bachelor of Science in Chemistry
Injectable. Shivaji University
Led a team of 20 in a fast-paced environment, developed, motivated them and ensured high team Diploma in Computer Application
productivity. Manipal Institute
Exceptional expertise in handling regulatory audits - USFDA, WHO, MHRA, TGA, ANVISA (BRAZIL) as
well as customer audits. Certifications
Proven leadership qualities with a dedicated approach to maintaining high quality standards and Effective Ways to Reduce
working on own initiative. Laboratory Errors 2019
Assay & Related Substances
Career Timeline Calculation by Caliber LIMS 2018
FDA Approval for Chemical &
Jun 2015 - Present Instrumentation analysis 2014
1 Assistant Manager in Quality Control Department
Encube Ethicals Pvt. Ltd.
Languages
Sep 2014 - Jun 2015
2 English
Manager Instrumentation in Quality Control Department
CHOKSI LABORATORIES PVT. LTD. Marathi
Jan 2011 - Aug 2014 Hindi
3
Sr. Officer in Quality Control Department
INDOCO REMEDIES PVT. LTD.
Hobbies
Apr 2010 - Dec 2010
4 Analyst Participating in Pharmaceutical
FDC PVT. LTD. PLANT-III industry seminars

Jul 2009 - Apr 2010 Reading Pharmaceutical journals

5 Analyst Team sports
CIPLA PVT LTD.
Jun 2005 - Jul 2008 Achievements
6 Analyst
HLL Life Care LTD. Received the certificate for Assay &
Related substances calculation by
Caliber LIMS in March 2018
Work Experience (Presented by Empower-3 waters
Software, Mumbai).

Jun 2015 - Present Obtained FDA Approval for chemical

& Instrumentation analysis of drugs
Assistant Manager in Quality Control Department in February 2014.
Encube Ethicals Pvt. Ltd.

Workdone:
Handled Laboratory Change Control, OOS, OOT, Laboratory incidence, Out of Calibration, and Deviation.
Conducted audit reviews and data backup verifications.
Avoided SOP limit deviations by insuring the sample analysis time period is within limits.
Planning of stability sample for analysis in Caliber LIMS software.
Monitoring the stability of products, stability study analysis, review of stability protocols and maintenance of stability chambers.
Provided timely customer stability reports, managed weekly, monthly & yearly section status updates to the management.
Managed and led a team of 20 personnel.
Implemented CAPA compliance and Good Manufacturing practices.

Achievements
Managed a team of 20 personnel.
Successfully monitored stability of products and maintained stability chambers
February 2023: Nishra Associates (Navi Mumbai) "Effective ways to reduce laboratory errors"
August 2023: In recognition with unique contribution towards curtailing the number of samples charged for stability w.r.to commercial US
ANDA embedded with PACO values. This has significantly decreased the wastage of samples.

Sep 2014 - Jun 2015

Manager Instrumentation in Quality Control Department
CHOKSI LABORATORIES PVT. LTD.

Workdone:
Planned outside sample analysis.
Communictated with external parties with respect to batch issues & sample analysis.
Generated a monthly turnover of up to 25lack for the company via the instrumentation section.
Handled 15 personnel as a team leader.
Managed OOS & Laboratory incidences with customer & FDA communication.

Achievements
Handelled a team of 15 personnel
Managed monthly turnover of up to 25lack.
Successfully communicated with customers and FDA regarding OOS & Laboratory incidences.

Jan 2011 - Aug 2014

Sr. Officer in Quality Control Department
INDOCO REMEDIES PVT. LTD.

Workdone:
Provided timely in-process reports to the production department for further process.
Planned in-process sample analyses.
Updated daily, weekly & monthly section status to management.
Managed and led a team of 12 personnel in shift.

Achievements
Managed a team of 12 personnel
Provided timely in-process reports

Apr 2010 - Dec 2010

Analyst
FDC PVT. LTD. PLANT-III

Workdone:
Conducted method validation, verification, and transfer analysis.
Handled HPLC analysis of API’s and excipients.
Worked as a Quality Control officer responsible for sample analysis on HPLC and GC.
Generated trend limits and qualified working standards.
Analyzed Tablets and capsule formulations.

Achievements
Handled complex analysis of Tablets and capsule formulations
 Managed HPLC analysis of API’s and excipients

Jul 2009 - Apr 2010

Analyst
CIPLA PVT LTD.

Workdone:
Performed HPLC analysis.
Handled Working/Reference/Chemical/Volumetric standard activities.

Achievements
Conducted complex HPLC Analysis
Managed Working/Reference/Chemical/Volumetric standard activities

Jun 2005 - Jul 2008

Analyst
HLL Life Care LTD.

Workdone:
Performed Chemical & Instrumentation analysis.

Achievements
Managed Chemical & Instrumentation analysis

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