Summary
Overview
Work History
Education
Skills
Accomplishments
Auditsfaced
Languages
Extracurricular Activities
Hobbies and Interests
Disclaimer
Areas Of Interest
Personal Information
Timeline
Generic

MOHIT ROHILLA

Pinjore, Panchkula

Summary

To Work with sincerity and dedication with a view to establish myself in progressive organization offering career growth and opportunities through proven performance and always strive to create a place for myself at the top and as the best.

Overview

12
12
years of professional experience

Work History

Sr. Executive-QA

Macleods Pharmaceutical Ltd.
Baddi
04.2019 - Current
  • Process performance qualification for the existing and new products
  • Risk assessment preparation for validation requirement for existing and new products
  • Cross functional team evaluation for change controls raised/changes proposed regarding process validation activity/hold time study/verification activity
  • Preparation of the Process performance qualification Protocols and Hold Time Study Protocols and respective reports
  • Preparation of Continuous Process verification protocols and reports for existing and new products
  • Handling of Change control, deviation and CAPA activities during process performance qualification activities
  • Technology transfer activity of new and existing products and handling the variation
  • Handling of queries raised by regulatory agency, MAH and preparation of response
  • Statistical evaluation of various Critical process parameters and critical quality attributes using Minitab software

Sr. Officer QA

Ind-Swift Ltd.
Derabassi
04.2018 - 04.2019
  • Company Overview: Eu GMP and MHRA certified 100 % EOU
  • To prepare the pre-requisite cleaning validation protocol and compilation of cleaning validation report
  • To prepare and execute the protocol of cleaning validation (dirty equipment hold time & clean equipment hold time study) and annual cleaning verification activity
  • Risk assessment and evaluate for introduction of new molecule or product in existing worst case cleaning study program
  • Preparation of the cleaning validation matrix, worst case rating, MACO calculation sheets for worst case identified
  • To prepare and execute protocols (URS, FAT, SAT, DQ, IQ, OQ and PQ) for Equipment qualification
  • To prepare the execute for HVAC validation study /requalification activities
  • To prepare annual planner for requalification activities for Equipment and HVAC system
  • TO perform the transport validation activity and compilation of report
  • Eu GMP and MHRA certified 100 % EOU

Sr. Officer QA

USV Ltd.
Baddi
05.2015 - 04.2018
  • IPQA activities at shop floor
  • Handling of deviation occurring at shop floor and CAPA activities for same
  • Preparation of the cleaning validation protocol, cleaning validation matrix, worst case rating, MACO calculation
  • Handling of change management (change control) system
  • Issuance of OOT, OOS, rejection note and maintenance of log books for same

Management Staff QA

Cipla Ltd.
Baddi
12.2014 - 05.2015
  • Process validation of tablets and Capsules
  • Cleaning Validation for all the new products, existing products and all the submission batches for regulatory authority
  • Product and equipment matrix preparation, Acceptance criteria calculation, Assessment of the changes occurred in the equipment, Process, Batch size and all other changes, which have impacts on the cleaning process validity

Jr. Officer QA

Hetero Labs. Ltd.
Baddi
12.2012 - 12.2014
  • Process validation of tablets and Dry Syrups
  • Preparation of the Validation Protocols and Hold Time Study Protocols
  • Preparation of the stability protocols and review of stability data before submission to any customer or Regulatory authority
  • Communication and response to Regulatory Affairs dept
  • Regarding all the queries regarding stability and process validation
  • Cleaning Validation and cleaning verification
  • Handling of the deviations raised during validation and handling the all changes in MFR and Batch records after validation through the Quality management system

Education

M.Pharm. - Quality Assurance

SHOOLINI UNIVERSITY OF BIOTECHNOLOGY AND MANAGEMENT SCIENCES
Solan, HP
08.2012

B.Pharm. -

Doon Valley Inst. of Pharmacy and Medicine
Karnal
07.2009

Skills

  • Communication skills
  • Good Analysis and Data interpretation skills
  • Emotionally stable
  • Punctual
  • Flexibility
  • Interpersonal skills
  • Teamwork skills
  • Stakeholder communication
  • Documentation review
  • Risk analysis and mitigation

Accomplishments

  • GATE-2009 qualified.

Auditsfaced

USFDA, Macleods Pharmaceutical Ltd., 2023, 2021, MHRA, Macleods Pharmaceutical Ltd., 2023, SAHPRA, Macleods Pharmaceutical Ltd., 2022, ANVISA, Macleods Pharmaceutical Ltd., 2022, MHRA, Ind-Swift, 2018, Phillipins, Ind-Swift, 2018, MHRA, USV, 2017, UAE, Cipla, 2015, Ethiopia, Hetero, 2013, WHO India, AstraZeneca, Pfizer, Sandoz, Lupin, Abbott, MSD, Glenn marc, GSK

Languages

  • Hindi
  • English
  • Punjabi

Extracurricular Activities

Participated in group dance in annual party of company in 2014. Participated in 'Singing Competition' in School and won 2nd prize. Participated in a skit regarding Energy Conservation.

Hobbies and Interests

  • Reading various regulatory guidelines and motivational Books
  • Traveling
  • Making new friends

Disclaimer

I hereby declare that the information given above is true to the best of my knowledge.

Areas Of Interest

  • Quality Management System
  • Documentation
  • Process development
  • Technology transfer
  • Validation & Qualification
  • Regulatory Compliance

Personal Information

  • Father's Name: Late Sh. Virender Rohilla
  • Mother's Name: Smt. Sudesh Rohilla
  • Date of Birth: 11/11/87
  • Nationality: Indian
  • Marital Status: Married

Timeline

Sr. Executive-QA

Macleods Pharmaceutical Ltd.
04.2019 - Current

Sr. Officer QA

Ind-Swift Ltd.
04.2018 - 04.2019

Sr. Officer QA

USV Ltd.
05.2015 - 04.2018

Management Staff QA

Cipla Ltd.
12.2014 - 05.2015

Jr. Officer QA

Hetero Labs. Ltd.
12.2012 - 12.2014

M.Pharm. - Quality Assurance

SHOOLINI UNIVERSITY OF BIOTECHNOLOGY AND MANAGEMENT SCIENCES

B.Pharm. -

Doon Valley Inst. of Pharmacy and Medicine

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