Quality Control Data Integrity
Resume:
909-***-**** Mahalingam
*********************@*****.**.** Quality Control Head – Formulation Vadodara, Gujarat, India
EXPERIENCE
QC Head – 11 years (with
max team size of 90+)
Section In charge – 11 Yrs
AREAS OF EXPERTISE
Sterile plants - 16 yrs of exp.
OSD- 16 yrs of exp.
Cephalosporin’s- 9 yrs of exp.
Audits: US FDA (12), MHRA(9)
EU GMP (4)
Data Integrity
GMP/GLP/GDP/AQbD.
Method validation & Transfer.
Cleaning Validation.
Process Validation.
OOS/OOT/OOC/Deviations
CAPA/Change control
Chemical & Instrument
Analysis
Root cause analysis (RCA)
Troubleshooting/compliance.
AUDITS
US FDA, UK MHRA, EU GMP
(Finland, Portugal, Netherland),
Denmark, Ireland, Norway,
WHO (Geneva), Brazil-ANVISA,
INVIMA- Columbia Ghana,
Uganda, Tanzania, Kenya,
Nigeria, Yemen, Oman, GCC,
Vietnam, Russia, Ukraine,
ISO9001, Merck Soreno (Italy),
S. Korea, GSK, UNICEF,
PARAXEL, LACHMAN
MAJOR INSTRUMENTS
HPLC, UHPLC, GC, ICP-OES,IC,
Polarograph, Osmometer,
Spectrofluorometer, Flame
photometer, Malvern
mastersizer & Zetasizer, Bottle
rotating apparatus, Dissolution
tester Type IV etc.
SOFTWARE SKILLS
MS Word, Excel & PPT.
Lotus notes & Outlook.
LIMS, QMS, EDMS, LMS,
EWS, SAP, ERP, SCM
SUMMARY
A result-oriented Pharma QC professional with planning, implementation, strong problem-solving skills and follow-up with 22 years of progressive experience needed to execute successful projects within timelines and ensures all standards are met. Led QC teams & sections in Sun pharma, Mankind Pharma, FDC ltd, Macleods Ltd, Wockhardt & USV Ltd with proven record of significant and successful contribution.
PROFESSIONAL EXPERIENCE
Quality Control Head May – 20 to present
FOP LLP Bangalore
Guidance to Site QC for US FDA, MHRA, EU GMP, WHO …. Accreditations.
Support non-conformance investigations to strengthen compliance.
Establishment & improvement of the Quality Control System.
GMP audits, gap analysis & compliance support, key risk & mitigation
Review and assistance to Data integrity evaluation & compliance.
Preparation, Revision of SOPs & other QC documents.
Qualification and validations support and its documentations
Greenfield & Brownfield projects.
Process improvements & Operational excellence
Gap Assessment & Vendor evaluation.
Quality Control Head Aug – 17 to present
Sun Pharma Baska, Halol
Led QC team of 60 + staff which include RM, PM, FG, Stability study, GLP, QMS, & Review section’s.
Release of Raw material, Packing material, In-process, Process validation, Finished goods & Stability study samples.
Investigation of OOS, OOT, OOC, analytical incidences, deviations etc.
Qualification, Calibration, maintenance of equipment’s & software’s.
Stability Study: Ensure studies are being conducted as per protocol.
Chemicals & standards inventory management.
Validation & Transfer of analytical methods.
Maintained cGMP & data integrity to ensure the safety, efficacy & quality of the products.
Product quality, Product recall investigation review & approval.
Review & Approval of QC documents.
Periodic review & updation of key systems & procedures.
Ensure readiness for internal & external audits.
Monthly report, Revenue, Capital Budget requirement review & submission.
Recruitment & Training management
New Lab project management.
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PRODUCT PORTFOLIO
SVP, LVP, Eye drops, Ear drops,
inhalation solution, Dry powder
injectable, Lyophilised products,
Powders, Tablets, Solutions,
Syrups, Suspension, Emulsion,
Hard & Soft gelatin Capsules.
TRAINING
Data Integrity.
AQbD.
OOS, OOT, Deviations, CAPA.
QMS/LIMS/LMS/EDMS
SAP/EWS
GMP/ICH.
Situational Leadership.
Steven covey’s 7 habits of
Highly effective peoples
CERTIFICATION
Certified Lead Investigator
(review & approval) for
OOS, OOT, Deviations &
CAPA
Steven covey’s 7 habits of
Highly effective peoples
LANGUAGES
English & Tamil: fluent
Hindi: intermediate
EDUCATION
B. Pharmacy [1996]
Annamalai University, TN
ACHIEVEMENTS
Set up new lab facility
Introduced new analytical instrument for Unite dose testing.
Achieved a KPI of 9.8/10 in regulatory filings for 3 consecutive yrs.
Reduced Manual error from 70% to 15% in testing in 2 yrs.
Successfully transferred 52 test methods from UK/Ireland to India.
Provided compliance for max of 40 OOS/OOT investigation & 70 Lab incidences within timeline in a month.
Introduced 5 Whys, Change/event analysis, Cause & effect fishbone diagram, FMEA, FTA, DMAIC as tools to find Root Cause.
Reduced, occurrence of
o OOS/OOT - from 1.5 to 0.05 per 100 tests in 3 yrs. o Lab events - from 3.0 to 0.25 per 100 tests in 3 yrs.
Achieved Monthly turn over from 15 crores to 125 crores within a 1 year
(as a part of team).
Given compliance for more than 1000 regulatory queries.
Outstanding contribution in regulatory filings of max of 50 per year.
Implemented of EDMS, LIMS, LMS, EDMS, SAP & EWS.
Achieved a max of about 80 releases in single day.
Introduced more than 70 test methods.
Strengthened data integrity in several companies from Scratch to Success.
Led QC team that never faced any international regulatory audits and cleared US FDA without any observation
Effectively increased utilization of Instruments from 40% to 90%.
Increased efficiency of QC performance by
o Introducing sections like GLP/Review/QMS/Chemicals & Glassware management
o Integration of FG & stability studies Section.
Taken extra responsibility of activities like testing/leading multiple sections like Review, GLP, RM testing, PM testing and Stability study in addition to my assigned responsibility of Section In charge.
Reduced cost of RM/RM retesting/In-process/cleaning validation samples analysis by implementation of reduced testing. WORK HISTORY
Position Company Team
size
QC Head
FDC Ltd, Baddi, HP 06/14 to 06/17 40
Nectar Life Sci, Baddi,HP 08/13 to 06/14 90
Mankind Pharma, HP 12/10 to 07/13 40
Section
Head
Macleods Ltd, Baddi, HP 10/09 to 12/10 20
Wockhardt Ltd, Aurangabad, MH 08/05 to 09/09 5
USV Ltd, Daman 04/02 to 08/05 8
Tablets India Ltd, Chennai, TN 02/98 to 03/02 1
(MAHALINGAM)
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