ra****@ya****.co & No phone number available.

Ramesh Chand Dogra

Quality Management System (QMS) professional having rich (More than 16 yrs) and diversified trouble shooting and Audit handling... | Ahmedabad, Gujarat, India

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Ramesh Chand Dogra’s Emails ra****@ya****.co

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Ramesh Chand Dogra’s Location Ahmedabad, Gujarat, India

Ramesh Chand Dogra’s Expertise Quality Management System (QMS) professional having rich (More than 16 yrs) and diversified trouble shooting and Audit handling exposure to Sterile manufacturing (Liquid, Lyophilized and Dry powder for injection) and Non Sterile Manufacturing (Tablets, Capsules -Soft gelatin and Hard gelatin) (Onco and Non Onco). Expert in designing , implementing and monitoring the effectiveness of Quality Systems as per major regulatory expectations on QMS, Aseptic Processing, Media fills, Audit/Compliance, Process validation, Qualification/Validation and Document Management. Expertise in designing the process/ work flows for the usage of IT enabled applications for effective tracking and management of QMS in Track wise, SAP system, LIMS, LMS and SMS -Sample Management System (Successfully implemented TW in Ranbaxy, Strides and Mylan) Vastly experienced in overall QMS management encompasses (Handling Change management, Deviations, Market Complaints, Root cause Analysis, QNR (Quality Notification reports), OOS, OOT & OOL (Out of Level)-Excursions (e.g. Environment, Utilities and Water) and CAPAs as per regulatory and regulators requirements. Successfully lead QMS in all major regulatory inspections like USFDA , MHRA , TGA , ANVISA , MCC , WHO , KFDA ,TPD , PMDA etc. Expertise in designing and executing Remediation Action Plans under regulatory actions like USFDA Warning Letters along with reputed consultants like PRTM, Lachman, Quantic, QUINTILES etc. Identifying areas for quality system improvement needs and designing CAPA in relation with regulatory inspection observations and actions and seamlessly execution the proposed actions end to end as in coordination with different functions. Accustomed with Pharmaceutical Quality System requirement and all major regulatory guidelines and expectations. Good Communication, behavioral skills along with Strong ability in team building and motivation.

Ramesh Chand Dogra’s Current Industry Zydus Group

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Work Experience

Zydus Group

Corporate Compliance Lead: Sterile /OSD/Topical/Biologics/Vaccine/Onco

Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Novartis

Senior Manager- Lead: Investigation/CAPA/QRM/FAR/Recalls/Escalations:OSD Formulations

Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Pfizer

Sr.Manager-Lead: QRM/Change Mgmt/Investigation/System Integration: Sterile and OSD Formulations

Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Hospira

Sr.Manager- Lead Quality Remediation:Aseptic Operations/Shop floor quality :DP/Liquid and Lyo

Sun Mar 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)

Mylan Laboratories Limited

Sr.Team Leader:Quality Lead (Onco:Injectables(Liquid/Lyo/TS) and OSD facility)

Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Feb 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)

Strides Inc.

Team Leader: Lead QMS/Inspection Mgmt/Quality Validation: Onco facility :Sterile/OSD Formulations

Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)

Ranbaxy

Sr.Officer : Manufacturing Quality/QMS/Audit Management

Fri Dec 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jun 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Vardhman Group of Industries

Executive Trainee: Product Development/Shop floor Quality Assurance

Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Him Academy (Hamirpur)

SME: Chemistry :IIT/JEE/AIEEE/PMT

Wed Jun 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

Ramesh Chand Dogra Email Addresses

ra****@ya****.co Work Email

ra****@ya****.co Personal Email

FAQ About Ramesh Chand Dogra

Ramesh Chand Dogra is located at
Ahmedabad, Gujarat, India

Ramesh Chand Dogra is a
Quality Management System (QMS) professional having rich (More than 16 yrs) and diversified trouble shooting and Audit handling exposure to Sterile manufacturing (Liquid, Lyophilized and Dry powder for injection) and Non Sterile Manufacturing (Tablets, Capsules -Soft gelatin and Hard gelatin) (Onco and Non Onco). Expert in designing , implementing and monitoring the effectiveness of Quality Systems as per major regulatory expectations on QMS, Aseptic Processing, Media fills, Audit/Compliance, Process validation, Qualification/Validation and Document Management. Expertise in designing the process/ work flows for the usage of IT enabled applications for effective tracking and management of QMS in Track wise, SAP system, LIMS, LMS and SMS -Sample Management System (Successfully implemented TW in Ranbaxy, Strides and Mylan) Vastly experienced in overall QMS management encompasses (Handling Change management, Deviations, Market Complaints, Root cause Analysis, QNR (Quality Notification reports), OOS, OOT & OOL (Out of Level)-Excursions (e.g. Environment, Utilities and Water) and CAPAs as per regulatory and regulators requirements. Successfully lead QMS in all major regulatory inspections like USFDA , MHRA , TGA , ANVISA , MCC , WHO , KFDA ,TPD , PMDA etc. Expertise in designing and executing Remediation Action Plans under regulatory actions like USFDA Warning Letters along with reputed consultants like PRTM, Lachman, Quantic, QUINTILES etc. Identifying areas for quality system improvement needs and designing CAPA in relation with regulatory inspection observations and actions and seamlessly execution the proposed actions end to end as in coordination with different functions. Accustomed with Pharmaceutical Quality System requirement and all major regulatory guidelines and expectations. Good Communication, behavioral skills along with Strong ability in team building and motivation. Zydus Group

Ramesh Chand Dogra currently works in the
Zydus Group

Ramesh Chand Dogra specializes in
Quality Management System (QMS) professional having rich (More than 16 yrs) and diversified trouble shooting and Audit handling exposure to Sterile manufacturing (Liquid, Lyophilized and Dry powder for injection) and Non Sterile Manufacturing (Tablets, Capsules -Soft gelatin and Hard gelatin) (Onco and Non Onco). Expert in designing , implementing and monitoring the effectiveness of Quality Systems as per major regulatory expectations on QMS, Aseptic Processing, Media fills, Audit/Compliance, Process validation, Qualification/Validation and Document Management. Expertise in designing the process/ work flows for the usage of IT enabled applications for effective tracking and management of QMS in Track wise, SAP system, LIMS, LMS and SMS -Sample Management System (Successfully implemented TW in Ranbaxy, Strides and Mylan) Vastly experienced in overall QMS management encompasses (Handling Change management, Deviations, Market Complaints, Root cause Analysis, QNR (Quality Notification reports), OOS, OOT & OOL (Out of Level)-Excursions (e.g. Environment, Utilities and Water) and CAPAs as per regulatory and regulators requirements. Successfully lead QMS in all major regulatory inspections like USFDA , MHRA , TGA , ANVISA , MCC , WHO , KFDA ,TPD , PMDA etc. Expertise in designing and executing Remediation Action Plans under regulatory actions like USFDA Warning Letters along with reputed consultants like PRTM, Lachman, Quantic, QUINTILES etc. Identifying areas for quality system improvement needs and designing CAPA in relation with regulatory inspection observations and actions and seamlessly execution the proposed actions end to end as in coordination with different functions. Accustomed with Pharmaceutical Quality System requirement and all major regulatory guidelines and expectations. Good Communication, behavioral skills along with Strong ability in team building and motivation.

Ramesh Chand Dogra speaks the following languages:
No languages available.

Ramesh Chand Dogra has prior experience in the following industries:
Novartis , Pfizer , Hospira , Mylan Laboratories Limited , Strides Inc. , Ranbaxy , Vardhman Group of Industries , Him Academy (Hamirpur)

Ramesh Chand Dogra has the following professional experience:
Zydus Group , Novartis , Pfizer , Hospira , Mylan Laboratories Limited , Strides Inc. , Ranbaxy , Vardhman Group of Industries , Him Academy (Hamirpur) .