A Profile for Team Leader or Head of Quality in Pharmaceutical Formulation (OSD and Sterile), API, Fermentation and Biologics.

1. Name of Candidate
Qualification
Position Applied
Total Experience
Current Company
Designation
Current CTC
Expected CTC
: Pradeep R. Shukla
: Master of Science
: Head/Team Leader/AGM Quality
: 12 Year
: USV Private Limited Daman
: Assistant Manager
: 5.70 Lac P.A.
: 30%–60% HIKE
(Negotiable: Based on job location and JD of the company.)
Notice Period
Current Location
Date of Birth
Marital Status
Children
Dependents
Language Known
Nationality
Contact Number
: 30 days
: Vapi Gujarat.
: April 04, 1985
: Married.
: 01
: 03
: Hindi, English, Marathi, Gujrati
: Indian
: +919408861775
PERSONAL PROFESIONALOBJECTIVE:
best reputation in regulatory market or looking to startup
for regulatory market with have broad range of products
perform best in favor of; growth of organization with full
team effort and do best in favor of my company boss and
team.
ACADAMICQUALIFICATION
Sr.
No Degree/Certificate
University/
Board
Year of
passing
Obtained
(in %)
4. M.Sc. Microbiology NMU, Jalgaon 2007 59.73 %
3. B.Sc. Microbiology NMU, Jalgaon 2005 60.70 %
2. H S C Nashik 2002 66.66 %
1. S.S.C Pune 2000 66.00 %
TRAININGUNDERGONE:
Sr.
No
Department/ Training Post
Total
Duration
3.
GAMP 5 & 21 CFR Part 11EU
Annex 11.
NA 3 Days
2. Training in HACCP Trainee 1 Month.
1. Training in Ayurveda Trainee 2 Months
PROFESSIONALEXPERIENCE:
Worked with K-Lab Thane, SUN Pharma Limited
Ankleshwar, BDR Lifesciences Vadodara, Abaris
Healthcare A’bad etc. of API and formulation Units in Q.C
and Q.A. Sections.
Firm/Company
Period
Designation
From To
USV Private Limited Nov-16 Till Date Asst. Manager QA
Over All Experience 12 Years
Note: Previous experience certificates lost. Educational
Certificates and documents of USV available.
CANDIDATE’SBRIEFINFORMATION: AUDITEXPERIANCE:
USFDA (2Times) Closed out 483WL of USV Pvt Ltd in
2018, MHRA 3 times, ISO 5 times, WHO 7 times, ANVISA
1 time.
FUNCTIONALABILITY:
CURRENT JOBROLE:
To join a firm and team, have a good vision, bestpolicies,
1.
includes sterile and nonsterile products. I am willing to
2.
energetic talent, achieve the goals, that appreciate my
3.
To perform and review OOS, OOT, Market
Complaint, Incidents, Deviation investigations
(Quality Investigation).
To review Quality Documents (SOP, Specifications,
Validation Reports, QRM, APQR).
To take part in Analytical Method Validations (AMV),
Verification and Method Transfer (AMT).
4. To perform and coordinate Computer System
Validation (CSV) and trainer of 21 CFR Part 11, EU
Annex-11 & GAMP 5 to implement ALCOA+++.
5. To be the part of Quality Audits and Compliance.
6. To take part in self-audits and walk through.
7. Maintain Quality Culture in firm.
8. To perform GMP Trainings.
9. To take part in microbiological quality control
activity as a Trainer, Investigator and Guide.
10. To takes part in manufacturing and quality strategic
management to implement overall quality culture.
11. To be the part of Cost Reduction and Productivity
increasing projects. Perform Quality Risk Management
(QRM).
ACHIEVEMENTS:
USV Private Limited (OSD & Injection):
 Take part in Closing Out USFDA WL (483) in 2017-
2018.
 Suggested to correct all system related SOP’s and
Procedures to the management, hence till date mostly
overall system is updated.
 Improved investigation process and instead of
hypothetical approach scientific approaches of
investigations implemented.
 Provided training on 21 CFR Part 11, EU Annex-11 and
GAMP 5 to about 200+ employees and validated about
70+ system in CSV.
 Given personal inputs in improving training
methodology, accepted by management and
implemented Tracking System in Training Modules,
Training Effectiveness and Trainer Evaluation system.
PRADEEP R. SHUKLA. (Master of Science):
Key Role: Q.A., Q.C., R.A. and MICROBIOLOGY (Engineer of Quality Culture)
Expertise: Process and Quality Development, QMS, Analysis, Design and Management of:
1. Molecules: API and Biologics.
2. Solid Orals: Tablets, Capsule, Powder, Syrups.
3. Sterile: Parenteral, Injectable, ophthalmic, Implants, Devices & Surgical.
4. Biotechnology: Proteins, Recombinant Gene Isolates, & Fermentation Isolate.
5. Medical Devices: Class I, Class IIa, Class IIb & Class III
PHOTOGRAPH
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2.  First time Analytical Method Validation SOP
Method Transfer, Method Validation and Verification,
Comparison study, OOT, OOS Procedure was changed
consultants.
and finished stage, Searched Regulatory Guidelines to
reduced them out, explained benefits of Skipped
Testing.
so that success should be our, designed the
documents in the form of QRM and till date 8
proposals get approved from US and EU agencies with
Minor Variations filling and CBE 30 filling.
 Suggested Artificial Intelligence implementation
in overall planning and decision-making activity so
that perfect planning will leads to on time
manufacturing and dispatch with zero fines and
penalties.
For API Firms:
Audit, Document Control, LIMS Master Specification,
Assurance.
 Process development for Gefitinib.
 Preparation of all SOP’s, Specs, AMV, PV and
Qualification Documents
 Prepared, Anticancer Drug system and ETP system
development.
 Products change over study for GDSCO.
 Cream, Ointment, Powder and beta lactam PD and
ADL.
For Oncology, Biotech, Sterile API & Formulations:
department of LVP Unit
 Analysis Planning and daily work monitoring
 Analytical Method Validation management.
 Reference standard and working standard
management
respect to calibration and AMC.
companies, Health ministry, Sport Ministry
Defense Ministry for launching the product inrelevant
fields
 Handled whole microbiology section independently.
 ADL on (L) Asparginase. Formulation development
Cefixime + flavonoid for proper formulation.
 Prepared documents and Quality System for ISO
9001:2015 and ISO 13485:2016
was INSTRUMENTS AND EQUIPMENTSHANDLED:
prepared systematically due to mine enforcement and 1.
as per the guidelines instead of direction of foreign 2.
 Attracted attention of management towards multiple 3.
time repeated analysis of same test in core, coated 4.
 By convincing management team, prepared strategy 5.
High Performance Liquid Chromatograph (HPLC):
Shimadzu 2010HT, Agilent 2100Series, Waters,
Perkin.
Gas Geometrography (GC): Shimadzu 2010 with head
space.
Infrared Spectrophotometer (Shimadzu IR Affinity)
Karl Fisher, Conductivity Meter, Incubator, Stability
Chamber, Microscope, Potentiometer, TOC
instruments, AAS, ICPMS, MS, IC, VITEK-2, Sterility
Analyzer.
Autoclave, BET Test Apparatus, DHS, Tunnels,
Anemometer, DOP testing, LAF, Air Pattern
Visualization test and preparation of videography with
respect to regulatory need.
6. In API GLR, SSR, VTD, TD, FBD, Centrifuge,
Micronizer, Pulverizer, Multimill, Shifter, Blender,
Press Filter, HPHV type reactor, Solvent Recovery
Unit, Cooling Tower, Chilling Plant, Vacuum Generator
(Water Ejector Type and Oil Type).
7. In formulation Granulator, Shifter, Multi-mill, Blender,
FBP, Tablet Compression Machine, Coating Machine,
Tablet Inspection Machine, Capsule Filling, Sterile
Powder filling, Syrup Filling, Ointment and Lotion
filling, all kind of packing lines and Track and Trace
System, Large Volume Parenteral Line, Pre and Post
Sterilized Product manufacturing lines.
 Did Overall design of Quality Control and Quality
Assurance to implement system.
 Prepared all initial documents like SOP, SMF, DMF,
CTD, and Specifications.
 Updated overall Vendor documents.
 Performed best for job role of Lab QA Reviewer, Self-
EXTRA CURRICULAREXPERIANCE:
worksheet and COA preparation and review, Dispatch 1.
Review, Batch Record review.
 Technology Transfer and Scale up activity Quality
Expertise in Medical Devices (Class I and Class II a)
generally wound management dressings, accident
management products and Surgical Products.
2. Expertise in product development and product design.
3. Compliance with respect to EU Directive and ISO/ISE
regulation for Medical Devices.
4. Expertise in fermentation technology, product
development, analytical development, scale up in
upstream and downstream process.
5. Expert in Ayurvedic Formulation Development with
respect to specified potencies, stability evaluation and
expiry evaluation.
PROJECTCOMPLETED:
 Performed management of QA, QC and Microbiology 1. Increasing the quality of Ayurvedic Asawa
2. Isolation of Metal tolerating Azotobacter Spp. and their
application in producing Biofertilizer, Siderophore
and SCP.
OTHERCURRICULARACTIVITES&HOBBIES:
 HPLC column and instrument management with 1) NCC Cadet for 2 years
2) Participation in institutional exhibition.
 Microbiological analysis management and Validations. 3)
 Training to QC personals.
 Sterility test validation, MLT Validation and all other
microbiological validation.
 Nano biotechnological isolation of PrP molecule.
 Bio-statistical project report preparation.
 Analytical research review and research data review.
 IPR review and Publication of research papers.
 Clinical Trials and data collection.
 Foreign customer handling.
 Meetings and marketing with
Working for Environmental Protective Activity.
4) Reading Spiritual Books, Ayurveda & Medical science
Magazine.
5) Photography.
COMPUTERKNOWLEDGE:
ERP, SAP, Auto-CAD, LIMS, Lotus, MS DOS, MS-Office,
ORACL, Photo Shop and Internet Savvy
DECLARATION:
I Pradeep Ramashankar Shukla hereby declare that all
multi-national the above information given by me is correct as per the
and best of my knowledge.
Name : PRADEEP RAMASHANKAR SHUKLA
Signature :
Date :
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