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Emcure Pharmaceuticals Ltd Jammu : EHS Manager
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[QUOTE=Guest;166188]CURRICULUM VITAE Mr. Rahul Nayak [b]E-mail [/b]: rahul1502 AT yahoo.com rahul_1502 AT rediffmail.com , rahual_1502 AT gmail.com [b]Career Objective [/b]: 4.5-years Experience (Quality Assurance) To grow up in the field of Pharmaceuticals and with the concrete contribution to the organization of which I become a part. A Quality Assurance Professional with a global regulatory experience (like USFDA, MHRA, ANVISA (Brazil), TGA, EDQM EUGMP, WHO Geneva) in the Pharma industry. Proven skills involving developing and motivating teams to achieve their objectives. Dedicated to maintaining high quality standards. Able to work on own initiative and as part of a team. [b]Responsibilities Handled [/b]: IPQA (In Process Quality Assurance) [b]- In Process [/b]: Knowledge of Capsule, Tablet , Packing area, Dry Syrup - Knowledge of cream, Ointment other Tropical Product. - Knowledge of all IPQA Activity. - Knowledge of dry injection. - Check environmental monitoring of area as per sop i.e. RH,Temp,.pressure differential - Sampling of all validation batch. - Preparations of IPCS ( INPROCESS CONTROL SPECIFICATION) - Review INPROCESS CONTROL SPECIFICATION(IPCS) - REVIEW of filled BMR &BPR AFTER COMPLETION BATCH. [b]Responsibilities Handled [/b]: [b]Documentation [/b]:( Validation & Qualification) - Preparation of area Qualification Protocol. - Preparation of process validation Protocol & Report - Preparation of cleaning validation Protocol. - Preparation of SOPs - Preparation of APQR (Annual Product Quality Review) - Distribution of SOP & retrieval of SOP as per distribution Records. - Preparation of HVAC Qualification Protocol. - Preparation of Equipment Qualification Protocol (IQ,OQ,PQ) - Review of Document. (BPRs) - SAP batch release after QC Release. - Deviations and Change Control initiation as Per SOPs. - Preparation of APQRs. - Preparation of Water trend. [b]Training Programs Attended [/b]: - Training on cGMP In Plethico Pharmaceutical given by Madhav Apte (2008) - One week program on “Secrets of Success”, by Dr Bharat Chandra (2009) - Training on World Class House Keeping given by Kirit Joshi (2010) - Training on GDP In Concord Biotech given by Kirit Joshi (2010) - Training on 21 CFR Part 11 In Concord Biotech given by Atit Desai (2011) - Training on cleaning validation In Concord Biotech given by Kirit Joshi (2011) [b]Audit Exposure [/b]: [b]- Regulatory Audit [/b]: EDQM, USFDA, TGA, ANVISA (Brazil) [b]- Customer Audit [/b]: Johnson &Johnson, Sanofi Aventis, APOTEX, Ranbaxy Zydus Cadila, GSK, Alkem, Wockhardt.Alembic. Industrial Experience [b]- Company [/b]: Concord Biotech Limited, Ahmedabad India [b]- Duration [/b]: Sept. 2010 to continue. [b]- Position Held [/b]: Senior Chemist Quality Assurance [b]- Functionality [/b]: Responsible to Manager-Q.A. Looking after Validation and Documentation Activity. Industrial Experience [b]- Company [/b]: ZYG Pharmaceutical Limited, Indore (formulation) [b]Duration [/b]: Dec.2009 to Sept. 2010. [b]Position Held [/b]: Q.A officer Documentation [b]Functionality [/b]: Responsible to Manager-Q.A Looking after Qualification [b]- Company [/b]: PLETHICO Pharmaceutical, Indore India (formulation) [b]- Duration [/b]: May 2007- to Dec.2009 [b]Position Held [/b]: Chemist in QA- Department as an IPQA Chemist [b]Functionality [/b]: Responsible to IPQA Executive Looking after In process. [b]Software Skills [/b]: - Operated QA module of SAP system. - Operated QA module of ERP system. - Operated QA module of DMS system. - Knowledge of MS Excel, MS Word, Power Point, Oracle. [b]ACADEMIC QUALIFICATION [/b]: - M.Sc. (Chemistry) (2007) Elective subject analytical Chemistry and Medicinal from DAVV University, Indore - B.Sc. (PCM) (2004) from Bundelkhand University, Jhansi [b]OTHER ACTIVITIES [/b]: - Participated “Seminar on Pericyclic reaction – 2006” in M.R.S.College Indore. - Participated “Seminar on International Congress of chemistry and environment – 2006 (FICCE).Indore - Participated “Seminar on lead compound – 2006-07” in P.M.B. Gujarati Science College, Indore. PROJECT: - Title: IR and NMR Spectroscopy and its interpretation Supervision: Dr. S. Muktibodh in P.M.B. Gujarati Science College, Indore.[/QUOTE]
