Ask Question / Post resume

Post a reply to the thread: www.m3vprojects.com Multi Three Victory Project Pvt Ltd Hyderabad : Project Architect

Your Message

Your Username:

Notes:-
1) You can copy and paste your full resume in the box below.
2) Or you can ask your question. We try to answer, as far as possible.

Title:

[QUOTE=Guest-IJT;139824]Name Amol R Barangule 
Designation Regulatory Affairs & Quality Assurance Executive 
Contact No. +91-9860957256 / 09975296802
Work Experience- 2 years.
E-Mail amol.barangule AT yahoo.com

PROFESSIONAL PROFILE

Objective To utilize the acquired skills and knowledge for carving out  career in Quality & Regulatory system, working towards achieving  organizational goals in hand with personal as well as professional  growth.
Brief Profile - Experience in the field of Quality Assurance and Regulatory Affairs. 
- Expertise of working on Quality Assurance. 
- Review OOS, Deviation, Change Control, CAPA & related documents.
- Equipment Qualification, Calibration and Critical processes validation. 
- Worked during cGMP and Quality audit including Internal & External  Audit (FDA & CDSCO, ISO 13485:2003 ) AATB & cGMP (In process)
- Organized cGMP Training and to Review training documents.
- Coordinate with Regulatory agencies for compilation and review of regulatory submission documents.
- Coordinate with Technology Transfer partner, Korea
Education Masters in Microbiology 
Bachelor of Science in Microbiology 
ADPQAM – Quality Assurance Management 
Work Experience 1. RMS Regrow Pvt, Ltd., Lonavla. Pune. ( Current Organization) 
 (Products are Cell culture, Tissue engineering and Stem Cells Based)
2. Ventribiological Vaccine Division Pune. ( Previous Organization)
 (Products are Cell culture based lyophilized vaccines)

RMS Regrow PVT, LTD., Lonavla, Pune. July 2009 to till date 
Roles and Responsibilities Regulatory Affairs & Quality Assurance Executive 
- Equipment Qualification – To Prepare, Review and Execute IO, OQ, PQ  Protocols for Equipment Qualification and ensure the activity as QA  Representative. 
- Reviewing- Reviewing of OOS, Deviations, Change Controls, CAPA and  other documents such as, QC TDS, Reports, SOPs, Protocols, Calibration  & Validation related documents.
 Reviewing of filled BMRs, BPRs, COA, Test Reports and Production & QA related documents.
- Area Inspection: Follow up of cGMP norms while manufacturing, filling,  packing and printing operation. Area inspection as per cGMP & GTP  norms and supervise the gowning Qualification activity. 
- Quality & Regulatory (cGMP Audit) -. TO Prepare Internal Audit  schedule, check list, observations & Compliances report audit as per  cGMP & Regularity norms or guidelines, Involve in Internal Audit  team as QA representative. 
Worked during various external Regulatory & certification audit  including FDA & CDSCO, ISO 13485:2003 BIS standards), cGMP,AATB  -American Association for Tissue Banking (In Process)
- Regulatory Affairs- Reviewing and maintaining the required Regulatory  documentation within Regulatory Affairs Section as per Regulatory  Requirements.
Issuance of audit observation to respective department & preparation  of External audit compliances report for submitting it to regulatory  agencies. 
To Circulate the updated Regulatory norms to concerned department.
 To maintain & updated External & Internal Audit log Register and related documents. 
- Validation Activities – To Prepare, Review, Execute and verifying  validation activity and documents by comparing it with defined standards  for Process, HVAC system, Autoclave, pass box , Biosafety cabinet &  Critical Processes validation. 
- Training -: To organize and/or impart cGMP training. To Prepare  Training schedule & Syllabus as per regulatory requirement,  coordinate it, document it and archive it. 
- Documents Preparation (Following documents are prepared in draft copy format). 
- To Prepare SOP for Change Control, Deviation, Corrective and  Preventive action, Management Review, Internal Audit and External Audit  Compliance Report.
- To Prepare, Issue, Review & maintain the SOPs as per cGMP & regulatory norms.
- Prepared Documentation for QA in draft copy format including - Tire I -  Quality – Manual as per ISO 13485: 2003, SMF, MFR, BMR, BPR Tire II-  SOPs, and Protocol. Tire III-Records and formats. 
- To Prepared TDS & formats for QC Microbiology including TDS for  GPT, Water testing, Disinfectant Efficacy Test, Gowning Qualification,  Environmental Monitoring and formats for Media preparation, utilization,  and decontamination. 
PREVIOUS WORK EXPERIENCE Aug 2008 to July 2009 
Ventribiological Vaccine division Hinjewadi., Pune Trainee Microbiologist (QA/QC Dept.)
- Drafting and/or preparing and review of Standard Operating procedure  (SOPs), Batch Manufacturing Records (BMRs) , Batch Packaging Records  (BPRs) and specifications.
- Issued SOPs, BMRs, BPRs and Protocols to department making Requisition and maintained records.
- To check the filled ‘BMR’ submitted Production Department and filled  ‘Test Data sheet; submitted file submitted by QC department as per the  checklist.
- Reviewing of COA and other related report and recombining for release of finished product.
- Worked during External Audit - : FDA & CDSCO.
- Performed Analysis & documentation in QC Microbiology section:
a. Environmental Monitoring by Settle plate, Contact plate, Air sampling & Swab method and Gowning Qualification. 
b. Water Sampling & Testing, Media Preparation, GPT, Disinfectant  efficacy test, Microbial culture maintenance and sampling for sterility  test as per cGMP & Regulatory norms. 
c. Operate TOC Analyzer, Autoclave Oven, Biosafety cabinet Incubator & Air Sampler (Merck) 
PROJECT EXPERIENCE SUMMARY (Haffkine Biopharmaceutical, Pune.)

Successfully Completed Project on “Russell’s viper venom Characterization and Antivenom production Studies”

EDUCATIONAL QUALIFICATION

Degree Institution / University Duration Marks Obtained 
ADPQAM IPER Institute Pune 2008-2009 54% 
Masters in Microbiology SRTMU Nanded 2006 - 2008 59%
Bachelors in Microbiology Shivaji University, Kolhapur 2003-2006 64%
HSC Pune, Board 2001-2003 58%

TECHNICAL SKILLS

Operating System MS Windows 2000 and XP
Other Utilities MS Office (Word, Excel, PowerPoint)
Use Software OP Program

MICROBIOLOGY SKILLS

Analysis and documentation for QC Microbiology as per cGMP &  Regulatory norms Sterility test, water sampling & testing,  Environmental Monitoring (viable count), Gowning Qualification,  disinfectant efficacy study, Microbial culture maintenance and GPT of  Microbial culture.

CERTIFICATION AND TRAINING 
Successfully completed certificate courses during academia
- ISO-9000
- Total Quality Management
- Quality Control and Quality Management.
All courses successfully completed in Advanced Training Institute Mumbai. 
(Govt. of India dept. of ministry & Labor Employment) 
PERSONAL DETAILS

Date of Birth 1 Jun 1985
Sex Male
Nationality Indian
Marital Status Unmarried
Hobbies Traveling, Swimming
Current Address Hirkani Society Shinde Nager Sangavi (old) Pune - 411027, Maharashtra, India

REFERENCE

1.0 Dr.Anil Kumane 
 Head QA, Bilcare Limited 1028, Shroli Rajgurunagar, Pune
 Mob.No.09922919018
 E-mail ID – anil.kumane AT bilcare.com / kumanea AT gmail.com

2.0 Sanjaykumar Mande
 Manager, QC Lupin Biotach pune 
 Mob. No.: 09049989181
 E Mail ID- sanjaykumarmande AT lupinpharma.com[/QUOTE]

All times are GMT +5.5. The time now is 02:34 AM.