AVIKASH SHARMA

Mobile: +918427998799| E-Mail:avikash.georgian@gmail.com

MIDDLE MANAGEMENT PROFESSIONAL

Specialities In: Quality Control & Compliance • Computer System Validation • Auditing • OOS • OOT • Data Integrity • QMS •
Investigation • CAPA
Solid communication skills with the ability to contribute as a team player and interface with professionals at all levels

PROFILE SUMMARY

• A result-oriented professional with experience of more than 11 years in the areas of Quality Compliance in Pharmaceutical
Regulatory domain
• Currently working with Centrient Pharmaceuticals India Pvt. Ltd. (Formerly known as DSM-Sinochem Pharmaceuticals India Pvt.
Ltd.), Punjab as Executive - Quality
• Expertise in Software Computer system Validation of analytical instruments used in Quality Control.
• Expertise in ensuring adherence to the quality standards i.e. cGMP, cGLP, Quality compliance, Data integrity and Quality
Management System.
• Expertise in handling OOS, OOT, laboratory investigations and laboratory incidences.
• Exposure to upgrade laboratory operations, maintain instrumental compliance.
• Holding MBA degree in Quality Management from BITS Pilani, helps to use various quality tools to identify issues and resolve then
to upgrade quality compliances.
• Expertise in overseeing laboratory operations involving qualification, calibration & servicing of analytical instruments.
• Abilities in formulating standard operating procedures and laboratory analytical methods for new processes to ensure Quality
compliance.
• Expertise in handling data through EDMS (Electronic Data Management System).
• Active involvement in Vendor qualification & management and auditing of commercial analytical laboratories.
• Conversant with USFDA, MHRA, TGA, PMDA & WHO GMP Certification and Various Customer Audits from different countries
• A keen communicator with honed problem solving skills and sound research mind as well as thorough knowledge of quality
compliances.

KEY SKILLS

Functional:
Quality Compliance | Data Integrity | Computer System Validation | GLP Compliance | Method Validations | Laboratory Operations |
Analytical Research | Audits & Inspections | Regulatory Affairs | Calibration | Technology Transfers | Quality management system |
Team Management/Trainings | Root Cause Analysis | Audit Compliances | OOS | OOT | CAPA | Statistical data analysis | Vendor
management

Technical:
• EDMS (Electronic Document Management System)
• Software Computer System Validation
• Users Acceptance Testing (UAT) of analytical software
• Analytical Instruments and Operating Software:
o HPLC (Waters, Shimadzu, Dinox & Agilent) with Operating Softwares (Empower3, LC Solution & Chromeleon)
o FTIR Spectrophotometer Perkin Elmer – Spectrum Two and Shimadzu –IR Prestige21)
o UV Vis Spectrophotometer (Shimadzu – UV 1700, Perkin Elmer – Lambda 25)
o Dissolution Apparatus (Electrolab – Syringe Pump, Lab India)
o Auto Titrator / Karl Fisher Metrohm - Tiamo
o General Instrument of Lab

Soft skills:
Leadership Skills | Driven to Succeed & Excel | Innovative in Thought & Solutions | Effective Business Negotiations | Decision-
Making Skills | Target-oriented | Positive Attitude | Time Management Abilities | Problem-Solving Skills | Strong Work Ethic
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 CAREER CONTOUR

Since July 2014: Centrient Pharmaceuticals (Formerly Known as DSM-Sinochem Pharmaceuticals India Pvt. Ltd.), Toansa
Punjab as Executive - Quality

Key Result Areas:

Strategic Responsibilities
• Strategize and plan continual improvements in all laboratory activities as per GMP and GLP requirements.
• Responsible for laboratory compliance for all analytical software, review policies on operating & analytical software and review the
audit trails of all analytical software of lab.
• Computer System Validation and Qualification of analytical instruments as per GAMP5 .
Operational Responsibilities
• Adhering to quality compliance in laboratory as per cGMP guidelines with key focus on Data integrity.
• Ensure effective implementation GLP activities in all the sections of the laboratory.
• Responsible for monitor data integrity and laboratory compliances in the quality control department.
• Accountable for data review & maintaining data integrity in the Quality Control.
• Efficiently & effectively managed Qualification (IQ, OQ and PQ) of all the Analytical Instruments of the Quality Control
• Actively involved in maintaining calibration and PM schedules; coordinating with different agencies for servicing and calibration of
instrument.
• Ensure the maintenance and approval of all working standards, reference standards and primary standards in QC.
• Access stability team for trending of stability study with the help of MS excel and Minitab.
• Participate in the investigations of laboratory incidences.
• Certified Auditor for Internal &External Audits; conducting internal & external audits mainly for commercial laboratories.
• Development quality goals to achieve organization planned targets.
People Responsibilities
• Supervising a team of 5 members.
• Taking care of Analyst Qualifications, providing training to new & existing employees in Quality Control domain.
• Setting KPI for subordinates, monitoring and guide them to achieve KPIs.

March 2013-July 2014: Wockhardt Ltd., Baddi (HP) as Junior Executive - Quality Control

Key Result Areas:

• Carried out analysis of raw material (mainly HPLC analysis).
• Acted as Second Line In-Charge of the Section.
• Preparing and upgrading standard testing procedures and standard specifications.

July 2011-March 2013: Ind-Swift Ltd., Global Business Unit (GBU), Punjab as Officer - Quality Control

Key Result Areas:

• Analysis of finished products & in-process samples.
• Coordinate with production team for in-process results.
• Held accountable for analytical method transfer.
• Handling analysis for market complaint samples and customer’s joint analysis.

July 2009-June 2011: Zydus Cadila Healthcare Ltd., Baddi (HP) as Chemist - Quality Control

Key Result Areas:

• Handled GLP compliance in laboratory.
• Calibration of Instruments.
• Skillfully managed daily monitoring functions of stability chambers.
• Preparing working standards.
• Worked in close relation with different agencies for servicing and calibration of equipment.

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 SCHOLASTICS PORTFOLIO

Masters in Business Administration - Quality Management in 2018

BITS (Birla Institute of Technology and Science), Pilani, Rajasthan

Post Graduate Diploma in Pharmaceutical Regulatory Affairs in 2013

JamiaHamdard (Deemed University), New Delhi

Masters in Biotechnology in 2009

HNB Gharwal University, Srinagar (UK)

Bachelors in Science - Chemistry, Zoology & Botany in 2007

Guru Nanak Dev University, Amritsar (Punjab)

Professional Certification: KAIZEN Practitioner from KAIZEN Institute Global, Switzerland at ZydusCadila Healthcare Ltd.in 2011

ACADEMIC PROJECT: Effect of Eugenol & Methyl Eugenol on Candidal growth & viability under Oxidative Stress from Jamia Millia
Islamia University, Central University, New Delhi, India

BEYOND CURRICULUM

• National Cadet Corps A, B and C Certificate Holder.

• Earn College Colour to represent and bring laurels to the college at various competitions and platforms.
• School Appointee in Boarding School (Military School); held accountable for managing 100+ students in a hostel.

REFERENCES AVAILABLE ON REQUEST

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