www.m3vprojects.com Multi Three Victory Project Pvt Ltd Hyderabad : Project Architect

[muthukalee]

Multi Three Victory Hyderabad : Project Architect

Job Description : Project Architect

Architects :
We require motivated, qualified architects dedicated to producing high quality commercial work, having strong conceptual and interpretive skills.
Excellent prospects are available for the right people.

Senior Architect :
With a minimum 5 years relevant experience, the successful candidate will have excellent design, presentation and communication skills.
We are also looking for strong team leadership qualities.

Project Architect :
The successful candidates will have a minimum 2 years post part 2 experience and will be used to working in a demanding team environment.
High quality residential experience and sound building regulation knowledge will be an advantage.
All candidates should be fully proficient in AutoCAD. A working knowledge of 3D Studio is desirable.

Project Managers :
We have vacancies for project managers with a minimum of two years relevant post qualification experience to initially run projects typically in the Rs. 50 Crore to Rs. 150 Crore construction value range.
Candidates will be self-motivated and confident in running multi-disciplinary project teams, commanding the respect of clients and peers. Good communication and accurate reporting skills are essential.
Excellent career development opportunities are available to successful candidates.

Please post your CV (marked confidential) to :
Mr. K. Badrinath
Multi Three Victory Project Pvt. Ltd.
#501, Maruthi Residency,
Street # 15, Himayat Nagar,
Hyderabad - 500 029, India.

Or Email to
badri@m3vprojects.com

About Us :
M3V group is a Multi-Faceted, Multi-Crore conglomerate with interests in Infrastructure, Real Estate, Software Services, Bio-Fuels, Modern Art and Advertising. With a successful portfolio of companies managed by a highly experienced management team, the group is designed to be one of the most trusted and fastest growing corporate entity of its kind in India.

Contact Us :
#501, Maruthi Residency,
Street # 15, Himayat Nagar,
Hyderabad - 500 029, India.
Tel : +91 40 2322 0623
E-Mail : info@m3vprojects.com
www.m3vprojects.com

[Guest-IJT]

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