1. VENKETESH.D
E-mail : venkat28p11@gmail.com
Telephone : +60-1119655884 (Hand Phone),
Address : NO: 31, Lorong 56,
Taman Petani Jaya,
Sungai Petani,
08000- Kedah, Malaysia.
Seeking for a leadership assignment in Quality Control Department.
Summary:
• 13 years versatile experience in Quality Control, Analytical research, Regulatory
audit and compliance functions of Active pharmaceutical ingredient and finished
dosage formulation.
• Well versed with all key functions of Quality control, Regulatory Affairs and
Analytical developments.
• Presently working as Manager - Quality Control and R&D at SM
Pharmaceuticals Sdn.Bhd., (Malaysia) wherein I am responsible for Analytical
method Validations/ Verification, Process validation, cleaning validation, stability
Study, Analytical R & D projects handling, Qualification of Instrument ( URS, IQ,
DQ, OQ and PQ) Analytical method transfer, Calibration, Documentation control,
Investigations, Regulatory compliance and Management for regular Quality Control
activities.
KEY SKILLS
• Able to prepare as well as execute independently Analytical Method transfer ,
Cleaning validation, Analytical method Validation/Verification protocols and
reports for Assay, Dissolution, Related substances and Comparison of dissolution
profile of development samples with innovator product.
• Total responsibility of analytical testing for all raw materials, packaging materials, in
process, finished products and stability testing.
• Generate stability study protocol and report, including stability data protocol setup
and maintenance, data review and trend evaluation, writing and evaluating
investigations, and addressing compliance challenges related to stability.
• Well Acquainted with chemical principles, Analytical Techniques, Analytical
instrumentation cGMPs and cGLPs
• Investigation of test results if occurs Out of Specification & Out of trends with the
Help of hypothesis.
• Calibration and maintenance of laboratory instruments.
• Review of Process Validation/verification protocols, cleaning validation, in process
and finished and stability data review, compilations and report generation.
• Well versed in qualifying newly procured analytical Instruments by preparing the
URS, DQ, IQ, OQ and PQ protocols.
Page 1 of 7

2. • Strong knowledge of lab computer systems and 21 CFR Part 11 Compliance, Well
aware of ICH, USFDA, MHRA and TGA, PCI`s guidelines for various analytical
activities (Validation/Stability /GLP/GMP).
• Responsible for GLP compliance in the laboratory by Conducting Internal audits.
• All QC related Document review, compilation within the timeline.
• Review sign off and compilation of the analytical data as per Requirement
WORK EXPERIENCE:
QC MANAGER (QC and R&D)
SM PHARMACEUTICALS SDN BHD MALAYSIA
MAY -2013 to till Date
[Managing a staff of 35 people .
12 years’ Experience in Quality Control Formulation (Tablets, Capsules, Injection,
Cream, Lotion, Suspension, Syrup and Dry Powder]
JOB PROFILE:
• Responsible for maintaining and improving the laboratory analytical testing
activities within the Quality Operations function and ensuring the provision of
quality control to the site.
• Lead, coach and develop the Quality Control Laboratory team, review colleagues’
performance, set and communicate objectives, priorities, metrics, development
plans and conduct performance assessments.
• Lead and manage the laboratory testing for Raw Materials, Packing material, in
process, finished product, and stability studies. Cleaning validation, Analytical
method validation, Process validation and analytical method Transfer.
• Supervising stability team members to design, plan, perform, interpret and report
results of stability testing and providing documentation support as per regulations
and regulatory guidelines.
• Trending of stability results and performs scientific and quality evaluation of
generated results.
• Generate stability study protocol and report, including stability data protocol setup
and maintenance, data review and trend evaluation, writing and evaluating
investigations, and addressing compliance challenges related to stability.
• Investigation of test results if occurs Out of Specification & Out of trends with the
help of hypothesis.
• Partner with cross-functional departments (staff) to ensure customer requirements
are continually met.
• Preparation of protocol ,Report and review of Analytical method transfer
• Ensure that documentation and laboratory processes are in a constant state of
regulatory compliance and inspection readiness.
• Approval of analytical protocols (specifications and methods) for new products and
the updating of existing protocols as per the latest Pharmacopoeia and requirements
as per the schedule.
Page 2 of 7

3. • Instruments/Equipment’s Qualification review and preparation of protocol and
report of (DQ, IQ, OQ& PQ of HPLC, UPLC, UV and QC other instruments).
• Preparation of new Standard Operating Procedures (SOP’s) and updating of all existing
SOP’s as per their current requirements. In charge of implementation of all SOP’s in
accordance with GLP requirements.
• In charge of commissioning of all required instruments, review and approval of calibration,
validation and revalidation reports.
• Training to Personnel to ensure that initial and appropriate continuing training is provided
and qualification of personnel for specific tests.
• Conduct trouble shooting on analysis, methods and on all instruments.
• Coordination in procurement of all Laboratory Instruments and Chemicals.
• To support Registration Department to comply with regulatory requirements for product
registration.
• Initiate and coordinate maintenance activities as and when necessary.
• QC Sample Management
• QC Retention Sample Management
• Other QC technical/ specialized activities.
• Ensure Quality Control policies or procedures are appropriate – Establish and/or revise , as
necessary
• Ensure regulatory and customer inspections readiness; represent area and participate in
audits
• Identify, develop and track performance metrics to effectively monitor laboratory
performance and customer support.
• Continually review and improve the laboratories’ operational support and efficiency
• Ensure necessary equipment qualification and method validations are complete, provide
oversight as necessary
• Ensure the necessary training within the department is carried out and modified according to
need.
• Ensure that documentation and laboratory processes are in a constant state of regulatory
compliance and inspection readiness.
• Continually review and improve the Quality Control’s operational support and efficiency.
• Support site’s Environment, Health & Safety performance objectives through compliance
with EHS rules.
• Providing guidance and coaching on issues related to his/her areas of responsibilities.
ASSISTANT MANAGER QUALITY CONTROL
FLAMINGO PHARMACEUTICALS LTD
Sep 2012 to April 2013
Page 3 of 7

4. JOB PROFILE:
• Project work and lab setup of beta lactum and non-beta lactam.
• SOP Preparation.
• Instruments/Equipments Qualification review and preparation of protocol and report of
( DQ,IQ, OQ& PQ of HPLC,UPLC,UV and QC other instruments)
• Analytical method transfer.
• Analytical method validation
• Calibration instrument planning and review the report.
• Stability study planning and review the document.
• Analyst Qualification.
• Analyst training.
• SAP Project Implementation Team member.
• Software Validation of Microsoft excel sheet.
• Responsible for analyzing dosage process validation and optimization samples, using
various chemical and instrumental techniques, in accordance with established compendial
and in-house testing methods.
• QC Sample Management
• QC Retention Sample Management
• Continually review and improve the Quality Control’s operational support and
efficiency.
• Ensure Quality Control policies or procedures are appropriate – Establish and/or revise , as
necessary
EXECUTIVE QUALITY CONTROL
MEDREICH LIMITED BANGALORE
Nov 2009 to Aug 2012
JOB PROFILE:
GLP Head and Finished product.
• Calibrations of instruments,
• Instruments/Equipments Qualification review and preparation of protocol and
report of( DQ,IQ, OQ& PQ of HPLC,UPLC,UV and QC other instruments)
• Qualification of working standard.
• Analyst Qualification.
• Preparation and review of Analytical Method Transfer protocol and Report
• Preparation and review of Analytical Method Validation and verification protocol
and Report Chromatographic column management.
• Training of analyst.
• Preparation of Raw material specification and Analytical work sheet
• Preparation of Finish product specification and Analytical work sheet
Page 4 of 7

5. • According to monthly plan check the specification , AWR, SAP master copy and
Preparation of analytical work record( AWR) of analytical method validation in
process/ finished product
• To maintain the labs with respect to cGMP norms and audit readiness.
• Review of Analytical report of raw material, in process and finished product.
• To trend data using graphing software as well as maintain analytical records on a
daily basis.
• Review of stability data of protocol and report, analytical report and trend results
• Responsible for the preparation of Quality Control annual Budget.
• Responsible for investigation and preparation of initial report on control samples
analysis during the customer complaint.
• Responsible for investigation of OOS.
• Ensure that the calibration of equipment /instrument has been carried out s per
Schedule and the records are in place.
• SAP result entry
• SAP master creation and correction of specification of raw material in process
and finished product.
EXECUTIVE QUALITY CONTROL
FAMY CARE LTD SARIGAM GUJRAT
May 2007 to Oct 2009
Finished Product /Raw Material Section Head:
• Planning, work allocation, review and release of all in process and finish products.
• Planning, work allocation, review and release of Raw material.
• Preparation and review of Analytical Method Transfer protocol and Report
• Preparation and review of Analytical Method Validation and verification protocol and
Report
• Trouble-shooting skills on all major analytical equipments like HPLC, GC, UV,etc.
• Responsible to generate accurate results while following GMP requirements.
• Responsible for analyzing dosage process validation and optimization samples, using
various chemical and instrumental techniques, in accordance with established
compendial and in-house testing methods.
• Review of stability data reports.
• Preparation of Finish product specification and Analytical work sheet.
• Software Validation of Microsoft excel sheet.
QUALITY CONTROL ANALYST
BAVISHYA PHARMACEUTICALS LTD
July 2003 to April 2006
• Analysis of Raw material, packing material, in process and finished product.
• Analysis of stability study sample
• Calibration of instrument.
• Online reporting.
• Stability sample analysis.
Page 5 of 7

6. • Process validation sample analysis.
• Cleaning validation sample analysis.
Dosage Forms Handled:
• Tablets : Combination products, Extended release tablets,
Sustained release tablets.
• Capsules : Tablet in capsule, Pellets in capsules
• Injectable : Small volume (SVP), Dry powders.
• Powders : Dry powder for oral suspensions.
• Food and Cosmetics : Foodstuffs, beverages and Shampoo, cold creams.
SOFT SKILS:
• Superior organizational skills;
• High level of accuracy and strong attention to detail;
• Ability to work independently, while supporting a collaborative, team-based
department;
• Ability to multitask to a high level and remain calm under pressure;
• Ability to consistently meet several simultaneous deadlines on an on-going basis;
• High level of professionalism, maturity, good judgment, and discretion when
dealing in confidential matters;
• Must be proactive, self-disciplined, and able to demonstrate a high level of
productivity;
• Willingness to learn with the ability to retain information quickly and apply
knowledge to various scenarios.
INSTRUMENTS HANDLED:
UPLC, HPLC, GC, UV Spectroscopy, FTIR, Dissolution, Disintegration, Friability,
Polari meter etc
AUDIT FACED;
• Successfully participated in Regulatory audit MHRA, TGA, MCC, USFDA,
UNICEF, Uganda, Kazakhstan, Zimbabwe, Kenya and NPCB Malaysia.
• Customer Audit Mylan, Sandoz, Novartis, Pfizer, GSK. Actives,
ACHIEVEMENTS:
• Independently successfully leading the Quality Control and microbiology
department of SM pharmaceuticals sdn. bhd .
• Set up of two Quality Control laboratories for beta lactum and non-beta lactum at
Flamingo Pharmaceuticals Limited, Nanded.
TECHNICAL CREDENTAILS:
• Exceptional computer skills with a high level of competence with MS Office
(Outlook, Word, Excel) and working with other databases;
Page 6 of 7

7. • Knowledge of implementing or working with SAP or other electronic laboratory
systems
• SAP master creation and correction of specification of raw material in process
• And finished product.
• Software Validation of Microsoft excel sheet (Calculation).
PROFESSINAL CREDENTIALS:
Bachelor of Pharmacy S.V.E.T. College of Pharmacy Humnabad.
Rajeev Gandhi University of Health
Sciences Ban galore. (Karnataka)
PERSONAL DETAILS:
Declaration
I take this opportunity to introduce my candidature with correct and true information as
per my Knowledge.
Place: Sungai Petani Yours Sincerely,
Date: VENKETESH.T.D
Page 7 of 7
Father’s Name : Tukaram. Dubalgundi
Date of Birth : 15/07/1977
Marital status : Married
1Gender : Male
Nationality : Indian
Language known : English, Kannada, Hindi and Telugu.
Permanent Address : Mallikarjun road (syed galli) Humnabad-585330
Dist Bidar. Karnataka INDIA