Shyo Parakash Saharan
Quality Assurance Manager at Indovax Pvt.Ltd.,Gurgaon- Claim this Profile
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Bio
Experience
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Indovax Pvt.Ltd.,Gurgaon
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Biotechnology Research
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1 - 100 Employee
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Quality Assurance Manager
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Dec 2019 - Present
Design and Review of master Documents(BMR, BPR and Testing Records and COAs, SOPs, VMP, SMF, EMP, Process Validation, Stability Studies), Deviation, Change Control, CAPA, OOS and OOT, Validation and Qualification of Equipment , Regulatory requirements Testing of Poultry Vaccines etc. Design and Review of master Documents(BMR, BPR and Testing Records and COAs, SOPs, VMP, SMF, EMP, Process Validation, Stability Studies), Deviation, Change Control, CAPA, OOS and OOT, Validation and Qualification of Equipment , Regulatory requirements Testing of Poultry Vaccines etc.
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Indovax Pvt.Ltd.,Gurgaon
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Biotechnology Research
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1 - 100 Employee
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Assistant Manager Quality Assurance
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Aug 2016 - Aug 2019
Effective implementation of QA SOP’s.Review of SOP’s of all section, validation protocol, BMR, BPR, BTR, COA’s as per master MFR/ specification.Co-ordination with Head QA for preparation/ upgradation/implementation of SMF/QMS/MFR/MVP/EMP/Specification for RM/PM/FP.Co-ordination with Head QA & other department for preparation of training matrix & effective implementation of training calender as per CGMP requirments.Issuance and retrival of documents i.e. BMR, BPR & COA etc.Effective participate in validation activities i.e. HVAC, SHS, DHS, Cold chain validation.Physical verification & check of domestic and export batches.Effective participation in internal & external quality system audit.Effective implementation of QMS systems i.e. Deviation, Change Control, CAPA.Provide support to the various divisions for effective and efficient implementation of the Quality Management System. Show less
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Sr.Officer Quality Assurance
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Dec 2011 - Aug 2016
In-Process QA, Validation, Review of BMR and BPR, SOPs and Protocol, Handling of Deviation and Change Control etc.
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Officer
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Dec 2010 - Dec 2011
IPQA and Design of SOPs, Review of BPR and BMR
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Venus Remedies Limited
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India
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Pharmaceutical Manufacturing
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400 - 500 Employee
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Project Trainee
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Jul 2009 - Jun 2010
Process Validation of Meropenum Injection Process Validation of Meropenum Injection
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Education
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Annmalai University
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Annamalai University
Master of Pharmacy, Quality Assurance