Pharmaceutical Industry Professional with around 11 years of experience in diverse quality assurance functions. I am open for any critical job responsibility in Pharmaceutical Industry that can instill versatile requirements of our industry.
Overview
11
11
years of professional experience
2015
2015
years of post-secondary education
3
3
Languages
Work History
Executive
Intas Pharmaceuticals Ltd.
Ahmedabad
12.2023 - Current
To supervise and perform shop floor duties as well as management of shift activities.
To perform any tasks and duties handed over by senior management.
To perform all IPQA activities, sampling, AQL in manufacturing area as per cGMP, guidelines and current SOPs.
Responsible for implementation and maintaining Cleaning Validation, Process Validation and Hold Time Activities within the facility.
To ensure that in process checks performed and related documents and records maintained on the shop floor as per SOP, GDP and cGMP.
To execute SAP and LIMS related work during routine manufacturing and final Batch release.
To review and release BPCR stagewise and to release BPCR for packing timely and efficiently.
To review and approve MPCR, annexures for SOP revision, impact assessment, annexures for Change Control as well as other QMS related documents.
Maintaining job description as per respective activities and training records as per assigned jobs for department employees and perform all tasks related to department training coordinator.
Senior Executive
Zydus Cadilla Ltd.
Ahmedabad
07.2017 - 10.2022
To perform all IPQA activities in Manufacturing and packing area as per cGMP.
To perform sampling at granulation stage for commercial & process validation batches.
Line clearance at all manufacturing stages.
Review preliminary investigation for particular deviation or change control.
Department Training Coordinator: To co-ordinate trainings for latest SOPs within department and perform as a training coordinator using TIMS.
Mapping of training needs for new employee.
To review BMR of all manufacturing stages.
Verification & calibration of all IPQA instruments.
To release the batches for packing department after reviewing all the manufacturing requirements.
To enter and ensure CPV data at all manufacturing stages of the batch.
To perform and execute process validation batches in manufacturing area.
Data entry in MINITAB & prepare graphs to perform statistical analysis.
Senior Executive
Cadilla Pharmaceutical Ltd.
Ahmedabad
11.2022 - Current
To Perform all IPQA activities in Manufacturing and packing area as per cGMP.
To perform sampling at all manufacturing & packing stages for commercial & process validation batches.
Line clearance at all manufacturing stages.
To review BMR of all manufacturing stages.
Verification & calibration of all IPQA instruments.
To release the batches for packing department after reviewing all the manufacturing requirements.
To enter and ensure CPV data at all manufacturing stages of the batch.
Preparation, Review and Revision of SOPs.
IPQA Officer
Mylan Pharma Ltd.
Ahmedabad
09.2015 - 07.2017
To ensure that all the manufacturing activities are going as per cGMP.
To perform IPQA activities during dispensing, granulation & compression.
Verification & Calibration of instruments and reviewing BMR, reviewing all logbooks of the area.
Perform & execute process validation.
IPQA Officer
Sparsh Bio- Tech Pvt Ltd
10.2014 - 08.2015
To perform IPQA activities during dispensing, granulation, compression, capsule filling and packing activities, calibration of instruments and reviewing BMR & BPR.
Qualification of all new equipments and instruments as per protocol.
Perform sampling for process validation batches as per process validation protocol.
Education
M.Pharm -
Atmiya Institute
B.Pharm - undefined
Parul institute
H.S.C - undefined
Sunshine High school
S.S.C. - undefined
G.D. Shah School
Skills
Quick learner
Information gathering
Flexible
Adaptive
Work under pressure
Communication skills
Interpersonal skills
Calm under pressure
Interests
Reading newspaper and magazines
Singing
Playing and watching sports
Travelling
Watching movies
Audits Faced
USFDA
MHRA
ANVISA
WHO
WHO-GENEVA
Interested Departments
Any Quality Assurance department where I can learn and upgrade my skills.
QA
Training and Development
QMS
Self-Inspection and Compliance
Corporate QA
Market Compliance
Validation and Qualification
Work Efficiency
M.S. Office
SAP
LIMS
TIMS
Documentum
Trackwise
Caste And Religion
Soni (Hindu)
Personal Information
Father's Name: Mr. Mukesh D. Vajani
Date of Birth: 09/20/90
Marital Status: Married
Disclaimer
I Pratik Vajani hereby declare that the above stated details are true to the best of my knowledge.