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Jitendra Sengar is listed as Quality Head at Brooks Sterisciences Ltd.( Quality (QA & QC) II Regulatory (US & EU) II Sterile (Injectables, Biologics & API ) II Audit II Microbiology Cipla, Ranbaxy,Wockhardt,Baxter and with Zydus ) at Brooks Sterisciences Ltd., based in Ahmedabad, Gujarat, India. AeroLeads shows a work email signal at ranbaxy.com and a matched LinkedIn profile for Jitendra Sengar.
Jitendra Sengar previously worked as Sr. Manager Quality at Brooks Sterisciences Ltd. and Quality Lead at Zydus Biologics. Jitendra Sengar holds M.Tech, Pharmaceutical Operation And Managements from Birla Institute Of Technology And Science, Pilani.
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I am a young, energetic, dynamic, and result-oriented professional and worked in Microbiology, QA, and in CQA compliance also. I have 17 Yrs of Experience in Pharmaceutical and Faces USFDA audit several Times. I worked relevantly in all fields of pharma like API, DF, and in Aseptic operations (penicillin, Cephalosporin, Penem's} apart from that worked in Terminal sterilization, Oncogenic Drug products, Biologics products, and in Vaccine products Manufacturing's units. I experienced several manufacturing lines and media fills as bellows; Dry powder injections, liquid Injections, Lyophilized drug products, Prefilled syringes, Cartridges, Vials, and Ampoules. I worked in reputed pharmaceutical companies and mixed easily with systems and his CFT members; Cipla Ltd, Ranbaxy Lab Ltd, Wockhardt Ltd, Baxter Ltd, and Zydus Groups. I energetically performed all tasks full of accountability and experienced handling a multicultural diverse team to get the timely expectation of our organization's needs. I academically got the first rank in all exams and am looking for me in the right career (fly High). I am married and have two kids.
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Vadodara, Gujarat, India
Heading Quality Operation for QA, QC and Microbiology, New Lines Developments, ANDA Filings, regulatory supports, Sterility assurance, PDR submissions, Vendor Developments, FAT for Filling Machines and Equipment, QMS, Market Complaints, Third Party managements, Mock recalls, External and internal Inspections and QRB meetings.
India
Quality and Regulatory with New facility establishment ( as a project lead) from facility Qualification to ANDA filings.all software for QMS elements, Monitorings and for validation use and developed time to time i.e Trackwise, SAP, LIMS, mini tabs, Lonza Moda and e-BMRs/BPRs etc
Ahmedabad, Gujarat, India
Team management of the multicultural diverse group and CFT, Human error based investigation, decision or investigational view during the batch release (have OOS, gross failure, media fills), Investigation during validation failure, EMPQ's USFDA exposure with Thomas arista and Massod.
Aurangabad, Maharashtra, India
Market Complaints, Product recalls, Self Inspections, Quality review meetings, Projects plans as per cGMP, water system failure, media fill failure, sterility failure, Pre-Clinical and Clinical batches, ANDA filings, USFDA Responses against EIR, USFDA audits Exposure; the auditor was Mr. alpesh Shah.
Dewas Area, India
Process validations, Media fill operations, exposure of different dosages like liquid Injections, dry Powder injection, antibiotics. USFDA Exposure; the auditor was Thomas arista and Robert. several Ex-USFDA auditors faced like Mike Goga, Anastasia. several consultants Faced; Parexal, Quantec and QCG.
Activities and Societies: Quality assurance and regulatory affairs, Total Quality Management, NDA and ANDA filings, pharmaceutical product.
Activities and Societies: Upstream and Downstream processings, Sterility assurance level, Cleaning and disinfection, Fermentation products.
Activities and Societies: TQM, MIS, QA and RA, HRM. NDA and ANDA filings, clinical studies, GDUFA, PDUFA, Statistical process control.
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Jitendra Sengar works for Brooks Sterisciences Ltd..
Jitendra Sengar is listed as Quality Head at Brooks Sterisciences Ltd.( Quality (QA & QC) II Regulatory (US & EU) II Sterile (Injectables, Biologics & API ) II Audit II Microbiology Cipla, Ranbaxy,Wockhardt,Baxter and with Zydus ) at Brooks Sterisciences Ltd..
AeroLeads has found 1 work email signal at @ranbaxy.com for Jitendra Sengar at Brooks Sterisciences Ltd..
Jitendra Sengar is based in Ahmedabad, Gujarat, India while working with Brooks Sterisciences Ltd..
Jitendra Sengar has worked for Brooks Sterisciences Ltd., Zydus Biologics, Baxter International Inc., Wockhardt Ltd., and Ranbaxy.
You can use AeroLeads to view verified contact signals for Jitendra Sengar at Brooks Sterisciences Ltd., including work email, phone, and LinkedIn data when available.
Jitendra Sengar holds M.Tech, Pharmaceutical Operation And Managements from Birla Institute Of Technology And Science, Pilani.
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