Pharma Microiologist / Quality Assurance
Resume:
CIRRICULUM VITAE
PRASHANT RAUT
Contact no. Mob. No. +91-921*******
E-Mail: *****.********@*****.***
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Summary statement: 9 years working experience with PROJECT exposure of Oral and Injectable plant (with BFS facility) from Pharmaceutical (Formulation) units. A result oriented challenging person who can achieve the set goal with value addition. Capability of planning and handling of department under tight schedule.
ACADEMIC MEMORANDA.
Post Graduation: M.Sc Microbiology from Amaravati University, Amaravati with 1st division in session April -2002.
PROFESSIONAL MEMORANDA
FDA Approved Chemist: Approval in instrumentation, Chemical and Microbiology from Himichal Pradesh
EMPLOYMENT HISTORY.
Nov 2006 till date. Promed Exports (P) Ltd. Baddi Sr. Executive QA
EU approved, ISO 13485 (CE marking) and ISO9001 (QMS) awarded by DNV company with BFS facility having small volume injection & Ophthalmic with going for future regulatory approvals of USFDA & MHRA. Capturing US & UK markets. Top in Ophthalmic Products in Russia and CIS countries.
Leading IPQA, Documentation and validation sections.
Daily planning and work distribution to team members and resolving their problems.
Handling of all IPQA activity from dispensing up to dispatch of Batches (dispensing and sampling of Material; CIP, SIP, in process checks and line clearance).
Handling of ERP system and follow-up with updating of daily activity.
Preparation of Bilingual COA for different countries.
Handling of Change control, Deviation, Incidence and OOS with investigation and CAPA.
Investigation of Market Complains and effective implementation of its CAPA.
Issuing and controlling all documents to all Departments
Handling of Training and its compliance with Documents.
Preparation and reviving of Master documents, Batch Records (BMR, BFR and BPR), SOPs & STPs.
Preparation and Compilation of Annual Product Review (APR).
Preparation and Compilation of URS, Impact Assessment, Risk Assessment, DQ, IQ, OQ, PQ, Validation protocol and Report.
Water Validation: WFI, Pure steam, Purified and Potable Water validation (Verification of component, P&ID verification, slope measurement, dead leg check, establishment of operating procedure, boroscopic, interlock verification, data compilation, calibration & certificate check)
Compress air validation.
Media fill Validation: Preparation and Compilations of Media fill Protocols and Reports.
Cleaning Validation: Establishment of Cleaning Validation protocol of area & equipment with matrix concept.
Equipment Validation: Execution and Compilation of equipment like as Blow Fill and Seal (BFS) Autoclave, DHS, LAF, Garment cubicle, Terminal sterilizer, Incubators and Stability Chambers etc.
Dip sticks calibration for Manufacturing Tank.
Calibration master plan: Preparation and maintain the record of different equipments.
Conduct customer/regulatory audits: Compilation & review of audit compliance report & response for closing.
Daily Compliance monitoring: Identifying the Gap with gaps analysis of all departments (as per 21 CFR Part 210 and 211), preparation of CAPA and follow-up for compliance.
Carry-out periodic Self-inspection and preparation of CAPA for observation.
Mar 2005 - Nov 2006. Torrent Pharma Ltd, Baddi QC Executive Microbiologist)
Established Microbiology Section and responsible for its functioning.
Day to day planning and work distribution for Microbiology Section.
Active member in UTILITY VALIDAION with QA Dept.
Follow Good Laboratory Practices in the operations of the laboratory
Qualification and validation of instrument and equipment.
Preparation of URS, FRS, DQ, IQ, OQ, PQ document and follow up with the party.
Validation of Microbiological method.
Validation of Micro analyst.
Validation of clean area, Microbiology lab as per Microbial aspect.
Validation of water system and purified water.
Cleaning validation.
Preservative efficacy of Liquid finishes product and Vitamin assay.
Preparation, authorization, implementation and periodic review of SOP / STP/ GTP / Data sheet and Validation Protocol for Microbiology.
Nov 2003-Mar 2005 Sun Pharma Industries Ltd, Silvassa QC Officer (Microbiologist)
Swab collection and personal finger dabs.
Day to day Microbiological analysis of Raw material, Finish product as per Microbial Limit test.
Water analysis of purified water and potable water.
Validation of water (purified and potable water).
Pathogen Testing.
Validation of Autoclave, DHS, Incubator and L.A.F (DOP test).
Environmental monitoring in manufacturing area by plate exposure and air sampling.
Preparation of Indicator, Reagent and Volumetric Solution.
Microbial assay of Antibiotic.
Preservation and maintenances of microbial culture.
ETP analysis.
Aug 2002- Nov 2003 SBL, Dadra Microbiologist.
Water analysis for microbial and chemical aspect.
Independently handling of RO plant.
Environmental monitoring in manufacturing area by plate exposure.
Maintaining of document as per BIS standards.
Audit Exposure:
1) SBL Dadra : BIS
2) Sun Pharmaceutical Ltd. : WHO, ABBOT INDIA, TANZANIA, NIGERIA
3) Torrent Pharmaceutical Ltd: NABL, WHO.
4) Promed Exports (P) Ltd : Pre ANVISA (Brazil), Actavis (UK), Apricot(Canada); EU GMP; WHO; ISO (CE Marketing); PharOS Generics(Greece); Ukraine etc.
Equipment Qualification.
BFS filling m/c, (Weiler, USA) Cartooning m/c (CAM)
Three piece filling m/c (BOSCH) Capping m/c (Kapsall, USA)
Leak testing m/c (WILCO) Autoclave (Pharmlab and Machin Fabrik)
Curricular Activities: Presented research poster at 42nd Micro-Biotech Annual conference of A.M.I. in Nov 2001, Gulbarga (Karnataka) India.
Computer literacy : M.S.Office, Internet.
PERSONAL MEMORANDA
Name : Mr Prashant Raut
Father Name : Mr. K.B. Raut
Permanent Address: Mr. Prashant K. Raut
S/o K.B. Raut
Chetna Nagar Sunderkhed
Buldana - 443001
Ph. No. +91-726*-******
National : Indian.
Martial Status : Married
Date of Birth : 12th August 1979
Sex : Male
Languages known : English, Hindi, Marathi.
Reference:
Mr. SukhvinderSingh Banga
Director Quality
Dr. Reddy’s, Hyderabad
I here by declare that the information given above is correct as per my knowledge and belief.
You’re sincerely
Date : _________________
Place : (Prashant K. Raut)
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