NIRAJ SHARMA
: +260979157237
QUALITY CONTROL MANAGER
Quality Control ~ Process Improvements ~ People Management
A result-oriented professional with excellence in implementing quality mechanisms to deliver desired output
Permanent Address: Village & Post Office, Reur, Tehsil Balh, District Mandi, (H.P.), India-175023
AN OVERVIEW
Quality Control Manager with 11+ years of work experience majorly in Pharmaceutical Sector. Expertise in quality control activities including audits recommending, implementing corrective actions, providing accurate documentation of statistical reports and ensuring overall compliance. Demonstrated excellence in communication skills with various levels of management, state & federal regulators stakeholders and suppliers. Well conversed with managing hardware & software aspects of Analytical Instruments. Skillful in reviewing & approving quality control records including environmental monitoring, deviations, Incidents, change controls, OOS and lab investigations. Effective communicator with strong analytical, problem solving and team building abilities.
PROFESSIONAL EXPERIANCE
Jun 2019 – Till : Yash Life Sciences Ltd, Kafue Lusaka Zambia MANAGER QUALITY CONTROL.
Mar’2016 – May’ 2019: Sun Pharmaceutical Industries Ltd., Baddi (India) as Sr. Executive – Quality Control
Dec’2014-Dec’2015: Panacea Biotec Ltd., Baddi (India) as Quality Control Executive
Oct’2013 – Feb’2014: Zenufa Laboratories Ltd., Kipawa Industrial Area, Tanzania as Executive
Oct’2010-Jul’2013: Ranbaxy Laboratories Ltd., Toansa (India) as QC Officer – Quality Control Department
Feb’2008-Oct’2010: Panacea Biotec Ltd., Baddi (India) as Quality Control Officer
Key Result Areas:
· Maintaining quality standards in the process, ensuring stringent adherence to quality standards, norms & practices, identifying gaps & taking corrective action
· Project Management of Quality Control Performing Qualification Validations, Analytical Method validation, Technology transfer etc.
· Responsible for rigorous testing of the methods to ensure that they are precise, accurate, reproducible, “fool-proof”
· Working in close coordination in work groups for conducting process audits and detailing on quality requirements and finalizing the quality plan
· Reviewing data, HPLC, SOP’s/ technical specifications / batch manufacturing record / validation protocols, validation reports and other quality documents
· Performing analysis of Raw Materials, Finish Goods and Stability Samples through HPLC (Waters and Agilent 1200) Empower-3 & EZ Chrome Elite Software
· Steering initiatives towards Change Controls & OOS Implementation
· Conducting routine calibrations and maintenance of instrument records as per GLP; including IQ, OQ and PQ of new equipment & technologies
· Taking care of data tabulation, analysis and graphical representation of the data; developing Working Standard Analytical Protocols and Standard Operating Procedures (SOP’s) and other GLP documents
· Accountable for carrying out literature search with conventional, electronic methods & modern analytical techniques, spectral interpretation and computer basics
· Directing, leading & motivating workforce and imparting continuous on job training for accomplishing greater operational effectiveness/ efficiency
INSTRUMENTS PURVIEW AND CALIBRATION
· HPLC, Polarimeter, UV-VIS Spectrophotometer, Analytical Balances, Disintegration Apparatus, Dissolution Apparatus, pH Meter, Tablet Hardness Tester and Refractive Index Apparatus
· UV Visible Spectrophotometer (Pharma Spec 1700) & Perkin Elmer
· FTIR 8400 S with IR Solution Software & Perkin Elmer
· Dissolution Tester 2000 (LABINDIA) and Disintegration Apparatus (Electro Lab)
· Autotitrator (Mettler Toledo)
· Karl Fischer Apparatus (Metler Toledo Dl-32)
· Refractive Index Apparatus
IT Skills
Conversant with Empower-3, EZ Chrome Elite, Learning Management System (LMS), Document Compliance Manager (DCM), LIMS & SAP (GUI), MS Office and Internet Applications
EDUCATION & CREDENTIALS
Masters in Business Administration (MBA)– TQM in 2009 (2 years) Madurai Kamraj University,Tamil Nadu, India (Total Quality Management)
Masters of Science (M.Sc) – Pharmaceutical Chemistry in 2007 (2 years) H.N.B., Garhwal, University, Shrinagar, India
Bachelors in Science in 2005 (3 years) H.P. University, Shimla, India
SUMMER TRAINING
Organisation: ZEE Laboratories Ltd.
Departments: Production and Quality Control
DECLARATION
I hereby declare that the above information is true to the best of my knowledge and belief
Date: 17 Feb, 2020
Place: Lusaka (Zambia) NIRAJ SHARMA
REFERENCES
Following persons may be referred to verify my credentials
Dinesh Singh Hemant Kuril
Sr. Executive, Quality Control Executive Quality Control
Sun Pharmaceutical Industries LTD. Sun Pharmaceutical industries Ltd.
Baddi, District Solan Baddi, District Solan
(H.P.), India (H.P.), India
Mob: +91-9816171557 Mob: +91-9805263861
[email protected] [email protected]
NIRAJ SHARMA
: +260979157237
: [email protected]
QUALITY CONTROL MANAGER
Quality Control ~ Process Improvements ~ People Management
A result-oriented professional with excellence in implementing quality mechanisms to deliver desired output
Permanent Address: Village & Post Office, Reur, Tehsil Balh, District Mandi, (H.P.), India-175023
AN OVERVIEW
Quality Control Manager with 11+ years of work experience majorly in Pharmaceutical Sector. Expertise in quality control activities including audits recommending, implementing corrective actions, providing accurate documentation of statistical reports and ensuring overall compliance. Demonstrated excellence in communication skills with various levels of management, state & federal regulators stakeholders and suppliers. Well conversed with managing hardware & software aspects of Analytical Instruments. Skillful in reviewing & approving quality control records including environmental monitoring, deviations, Incidents, change controls, OOS and lab investigations. Effective communicator with strong analytical, problem solving and team building abilities.
PROFESSIONAL EXPERIANCE
Jun 2019 – Till : Yash Life Sciences Ltd, Kafue Lusaka Zambia MANAGER QUALITY CONTROL.
Mar’2016 – May’ 2019: Sun Pharmaceutical Industries Ltd., Baddi (India) as Sr. Executive – Quality Control
Dec’2014-Dec’2015: Panacea Biotec Ltd., Baddi (India) as Quality Control Executive
Oct’2013 – Feb’2014: Zenufa Laboratories Ltd., Kipawa Industrial Area, Tanzania as Executive
Oct’2010-Jul’2013: Ranbaxy Laboratories Ltd., Toansa (India) as QC Officer – Quality Control Department
Feb’2008-Oct’2010: Panacea Biotec Ltd., Baddi (India) as Quality Control Officer
Key Result Areas:
• Maintaining quality standards in the process, ensuring stringent adherence to quality standards, norms & practices, identifying gaps & taking corrective action
• Project Management of Quality Control Performing Qualification Validations, Analytical Method validation, Technology transfer etc.
• Responsible for rigorous testing of the methods to ensure that they are precise, accurate, reproducible, “fool-proof”
• Working in close coordination in work groups for conducting process audits and detailing on quality requirements and finalizing the quality plan
• Reviewing data, HPLC, SOP’s/ technical specifications / batch manufacturing record / validation protocols, validation reports and other quality documents
• Performing analysis of Raw Materials, Finish Goods and Stability Samples through HPLC (Waters and Agilent 1200) Empower-3 & EZ Chrome Elite Software
• Steering initiatives towards Change Controls & OOS Implementation
• Conducting routine calibrations and maintenance of instrument records as per GLP; including IQ, OQ and PQ of new equipment & technologies
• Taking care of data tabulation, analysis and graphical representation of the data; developing Working Standard Analytical Protocols and Standard Operating Procedures (SOP’s) and other GLP documents
• Accountable for carrying out literature search with conventional, electronic methods & modern analytical techniques, spectral interpretation and computer basics
• Directing, leading & motivating workforce and imparting continuous on job training for accomplishing greater operational effectiveness/ efficiency
INSTRUMENTS PURVIEW AND CALIBRATION
• HPLC, Polarimeter, UV-VIS Spectrophotometer, Analytical Balances, Disintegration Apparatus, Dissolution Apparatus, pH Meter, Tablet Hardness Tester and Refractive Index Apparatus
• UV Visible Spectrophotometer (Pharma Spec 1700) & Perkin Elmer
• FTIR 8400 S with IR Solution Software & Perkin Elmer
• Dissolution Tester 2000 (LABINDIA) and Disintegration Apparatus (Electro Lab)
• Autotitrator (Mettler Toledo)
• Karl Fischer Apparatus (Metler Toledo Dl-32)
• Refractive Index Apparatus
IT Skills
Conversant with Empower-3, EZ Chrome Elite, Learning Management System (LMS), Document Compliance Manager (DCM), LIMS & SAP (GUI), MS Office and Internet Applications
EDUCATION & CREDENTIALS
Masters in Business Administration (MBA)– TQM in 2009 (2 years) Madurai Kamraj University,Tamil Nadu, India (Total Quality Management)
Masters of Science (M.Sc) – Pharmaceutical Chemistry in 2007 (2 years) H.N.B., Garhwal, University, Shrinagar, India
Bachelors in Science in 2005 (3 years) H.P. University, Shimla, India
SUMMER TRAINING
Organisation: ZEE Laboratories Ltd.
Departments: Production and Quality Control
DECLARATION
I hereby declare that the above information is true to the best of my knowledge and belief
Date: 17 Feb, 2020
Place: Lusaka (Zambia) NIRAJ SHARMA
REFERENCES
Following persons may be referred to verify my credentials
Dinesh Singh Hemant Kuril
Sr. Executive, Quality Control Executive Quality Control
Sun Pharmaceutical Industries LTD. Sun Pharmaceutical industries Ltd.
Baddi, District Solan Baddi, District Solan
(H.P.), India (H.P.), India
Mob: +91-9816171557 Mob: +91-9805263861
[email protected] [email protected]