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[QUOTE=Guest-IJT;151154][b]Name [/b]: bhushan.bhamare
[b]Email [/b]: bhushan.bhamare AT rediffmail.com
[b]Designation / Skillset[/b] : asst.manager

[u][b]Resume[/b][/u] :
 
[b]- Career Objective [/b]:
To excel in Pharmaceutical related activities and to acquire a post in an organization where good interpersonal skills are required.
[b]- Educational Qualification [/b]:
CLASS YEAR OF PASSING % SECURED BOARD
MBA Ongoing Ongoing Tripura University
B.Pharm 2003-04 65.75 % Pune University
H.S.C. 1999-00 64.23% Nasik Board
S.S.C.
 1997-98
 62.35 % Nasik Board
COMPANY
 NATURE OF WORK
AUDITS Successfully faced & handled USFDA, MHRA, TGA, MCC, ANVISA ,MCC Audits in Dr.Reddys Lab ,Cipla kurkumbh & Emcure Pharmaceuticals.
Emcure Pharma Limited
as a Asst. Manager
Tech Transfer
From Nov. 2010 to till date Timeline Framework ;
- Prepare task break structure, timelines & manage assigned projects.
- Track man hours & equipment hours for each project.
- Compare projected expenses Vs actual for each project.
- Co-ordinate with R & D & cross functional teams to track the project.
- Lead all documents control for impact on product quality, safety, efficacy and 
impact to the regulatory filing.
- Provide support for manufacturing locations of new product introductions
 or filings.
- Support new product launches.
- Provide support for quality audits, initial site approvals.
[b]Product Quality Investigations & CAPA  [/b]:
- Quality ownership of Product Quality Investigations associated with complaints.
- Manage effective complaint handling, Complaint investigation and CAPA processes in partnership with key stakeholder departments in line with the global procedures.
- Manage Recalls and in Market action.
- Quality and Technical complaint and quality investigations.
Ensure inspection readiness.
- Monitor metrics - validation, complaints, investigations, QC OOS etc.
- Ensure sites are in compliance with the regulatory requirements for management of complaints.
Centaur Pharma Pvt. Ltd., Pune
In QA from Sept. 2009 to Nov. 2010
Dr. Reddys Lab
Hyderabad as a Jr. Manager in Tech Transfer Department
fr om April 2007 to Sept 2009
Cipla Kurkumbh in QA Dept. as Cleaning validation section incharge from Dec. 2004 to Aug 2006 Project
- Currently working on site transfer activities i.e. product transfer from US, Canada, Israel to India.
- Hands on experience on various site transfer and regulatory requirements.
- Hands on experience to manage assigned products to be transfer as per market requirement.
- Responsible for the review of batch manufacturing records and the process of manufacture supporting the decision to release product in compliance with all license and cGMP requirements.
- As technical person, required to review requests to vary the process of manufacture as a result of local events and specify any additional work required in order for product to be safe and efficacious.
- Maintain up to date knowledge of pharmaceutical legislation and best practice.
[b]Qualification [/b]:
- Preparation of Equipment & AHU Qualification protocols in accordance with ISO Standards .
- Preparation of Master Validation Plan summarizing brief introduction of the Organization.
- Preparation of Equipment URS & DQ .
- Preparation of Risk Assessment Document related with Mfg Process & Equipment & related SOP.
- Preparation of Water System Validation Protocol.
- Attended FAT for customized Equipments & Preparation of FAT report.
- Preparation of Qualification & Validation SOP.
- Handling of customer department queries.
[b]Auditing Activities [/b]:
- Provide input into the development and maintenance of a global audit strategy and Quality Assurance function
- Prepare, review and provide input into Quality Assurance processes, and associated documentation.
- Assist in the preparation and maintenance of a global audit schedule.
- Vendor audits schedule preparation & followup.
- Organize, lead and participate in contracted audits (investigator sites, trial master files, database, study reports etc.) and internal audits (systems, processes, vendors, computer system validation etc.) across global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
- Preparation of reports to Senior Management documenting audit activities, metrics, findings and resolutions; and raise significant issues of non-compliance.
- Train, and provide guidance to less experience and/or contract auditors.
- Provide training to employees on ICH GCP, FDA regulations and other applicable regulatory standards.
- Assist in coordinating and conducting company training programs.
- Manage, host and support sponsor audits and Regulatory Authority inspections. 
[b]Technical(Equipment related)  [/b]:
- Independent handling & Troubleshooting of Fluid Bed equipment(PamGlatt,Alliance,Umang),Ganscota(Ganscota),Neocota(Neomachine),Compression machine(Sejong, Legacy),RMG(Saral),Octagonal Blender(Saan),Ointment Mfg vessel ,Blister packing & bottle packing line.
[b]Process Validation [/b]:
- Worked in Beta pharm Product Transfer Project (Phase I & Phase II) of Dr.Reddy’s , involving setup of Pre-Exibit ,Exibit & Commercial Batches. 
- Looking after Process Validation section, including Preparation of Validation Protocols & Review.
- Preparation of Process Validation module including various stages of sampling & their collection.
 Closing of Incidents & Deviations during routine Mfg Process.
- Preparation of Master Production Record & Validation Protocol for Exibit & Commercial Batches.
- Handling of customer department queries.
- Planning, execution & controlling of various activities involved in scale up operation.
[b]Technical (Product related)  [/b]:
- Particle size optimization technique by Sieve analysis & by controlling Granulation (Top Spray) in case of retard formulation.
- Compression Stage Troubleshoot like Sticking, Picking, Capping, weight variation.
[b]Molecules/Projects Handled  [/b]:
- Top Spray granulation Projects
- Wet granulation
- Process time reduction Project
[b]Software Validation  [/b]:
- Preparation of Software Validation Protocols related with Stability chamber .
- Preparation of computer system validation protocol for system interlink with network.
- Have hands on experience related with Gxp systems.
[b]Qualification [/b]:
- Preparation of Equipment & AHU Qualification protocols in accordance with ISO Standards .
- Preparation of Master Validation Plan summarizing brief introduction of the Organization.
- Preparation of Equipment URS & DQ .
- Preparation of Risk Assessment Document related with Mfg Process & Equipment & related SOP.
- Preparation of Water System Validation Protocol.
- Attended FAT for customized Equipments & Preparation of FAT report.
- Preparation of Qualification & Validation SOP.
- Handling of customer department queries.
- Planning, Organizing & controlling of various Qualification activities generated during new Projects.
- Involved in technical discussion of Equipment Purchase at the time of URS preparation in co-ordination with User & Projects department.
[b]Qualification Projects [/b]:
- Worked as a Team leader for Area & Equipment Qualification Project in 
 DRL (Phase-II, Phase-III,TSV Module, Betapharm Module) 
[b]Cleaning Validation  [/b]:
- Looking after Cleaning Validation section, including Worst Case Study of Tablets, Capsules.
- Preparation of QA SOP of Cleaning validation.
- Preparation of Study Protocol & Report for Bioload study of the cleaned & Un cleaned equipments.
- Preparation of Cleaning Validation Matrix (Area wise Vs Product wise) from which Worst case Product gets selected. 
- Preparation of Justification of Swab for Hard to Clean area.
- Preparation of Worst case chain from which worst case product 
Selected for calculation of Dose Criteria & 10 ppm criteria. 
[b]Quality System  [/b]:
- Setup & handling of quality system including change control, Deviation 
 management , CAPA management, Internal audit & compliance.
 [b]Extracurricular activity [/b]: 
- Participated in inter college cricket tournament and carrom.
- Participation in 54th IPC function in pune. 
- Seminar delivered on GATT in AISSMS College of pharmacy
 
Declaration-I hereby declare that all the information furnished above is true to the best of my knowledge and belief and i am confident regarding my ability to work in a team.
[b]DATE [/b]: BHUSHAN BHAMARE
-------------------------------------------------------
[b]More Information about this submission and submitter [/b]:-
___________________________________________________
[b]Submission ID  [/b]: 4455147
[b]Date & Time  [/b]: 7th Aug 2011 3:28 PM (UTC)
[b]IP Address  [/b]: 49.14.17.25
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