Nilambar Rout is seeking an opportunity to utilize his skills and experience to contribute to an organization's success. He has over 4 years of experience in quality assurance roles at various pharmaceutical companies. His responsibilities have included vendor qualification, training management, audit coordination, and ensuring compliance with cGMP guidelines. He holds an MSc in Industrial Biotechnology and BSc in Biotechnology. He is proficient in MS Office, C programming, and has participated in various academic and extracurricular activities.
Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) -which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.
Our group of learned professionals from above mentioned sectors of the pharma and healthcare industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance and e-learning platform provider for pharmaceutical and healthcare professionals in the aeas of GMP, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy online/distance sources of GMP information, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of online seminars, distance/online courses as well as training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma and healthcare GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management etc areas have been approved and certified by Quality Council of India.
The IGMPIs team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and healthcare manufacturing easily accessible, through this platform.
1. CURRICULAM VITAE
Nilambar Rout
Contact No: 9586216672, 09090559833
Email: nilambarrout1989@gmail.com
Correspondence:
Avishek Apartment, In front of the Shiv temple, Ragini.
GIDC, Ankleshwar. Dist.: Baruch. Gujarat.
OBJECTIVE:
I am looking forward to an opportunity where, I can utilize my skills and experience in contributing effectively to
the success of the organization and also further improve my personal skills by taking challenging assignments
with latest development to the field.
PROFESSIONAL EXPIRIENCE:
Total experience: ~ Four years
Currently working in Alkem Laboratories Ltd, Ankleshwar since Jun 2015 as an Officer.
One years and two months experience in Zydus cadilla Healthcare Ltd., Ankleshwar as Chemist in
Quality Assurance Department, From May 2014 to June 2015.
Work experience in Calyx Chemicals & Pharmaceutical Sciences Ltd, Tarapur starting
From Dec-2012 to the year 2014 and as Associate Q.A.
EXPOSURE TO REGULATORY AUDITS
CDSCO(2015)
USFDA(2015)
MAXICAN AUDTS (2014)
EDQM
FDA (Local Indian)
CORPORATE AUDIT.
JOB PROFILE:
Responsibilities handling in current organization (Alkem Laboratories Ltd)
• Vendor Qualification.
• Complete overview of Trainings Management Systems across the site through E-TMS
software”Nichelon” (21 CFR approved)
• Providing cGMP & On the Job trainings.
2. • SOP preparation in coordination with cross functional departments.
• Coordinating for regulatory and customer audits.
• Coordinating implementation of defined procedures across sites.
• Identifying existing gaps in practices versus corresponding SOPs.
• Review of master BPCRs
• Conducting Gap Analysis for written procedure versus actual procedure and evaluating its associated
risk/s.
Complete Accountability of IPQA Activities with IPQA team.
• Performing Finished product sampling.
• Review of executed BPCRs
• Review of Analytical documents.
Responsibilities handled in previous organization (Zydus Cadilla Healthcare Ltd)
• Handling pre shipment end sample and related documents qualification for vendor Qualification.
• Assign source assignment for approved vendor in SAP.
• Arrangement & review training c-GMP, Safety, on the job Training & Unscheduled training.
• Handling of Self inspection
• Review of the master & executed BMR.
• Preparation of APQR.
• Give UD in SAP System.
• To assist Change Control, Out of Specification, Deviation etc.
• To assist in Customers and Regulatory Agency Audits.
Responsibilities handled in Calyx chemicals and pharmaceuticals ltd
Monitoring the IPQA activity in all departments in order to comply the parameter accordance with standard
specification.
• Giving line clearance to the production department for product change over cleaning or facility modification.
• Reviewing BMR, Protocol & Report.
• Preparation of final release order.
• To verify the finished goods during DISPATCH and review of the dispatch documents.
• Checking the online documentation in the plant. (Online BMR, BPR, BCR etc.)
• Monitoring of Critical process parameters
3. • Verifying the differential pressure, daily balance performance, labeling procedure in the plant and reviewing the
cleaning records, equipment’s, instruments log books etc.
PROFESSIONAL QUALIFICATION:
• M.Sc in Industrial Biotechnology with C.G.P.A. - 8.1 from School of pharmaceutical
sciences, S ‘O’A University, Bhubaneswar, Odisha ( Division-First Class )
• BSc. Biotechnology with 64% from MITS School Of Biotechnology, Utkal University,
Bhubaneswar ( Division-First Class )
ACADEMIC QUALIFICATION:
• 12th from, Baba Panchalingeswar collage, C.H.S.E, Odisha.
• 10th
from, Kailash Chandra High School, HSC, Odisha.
PROJECTS UNDERTAKEN
• Project work done on “Microbial Diversity” from NIIT University, Rajasthan.
STRENGTHS
• Good Team Sprit, willingness to learn , group management,
• Logical initiation, Positive thinking.
HOBBIES:
• Playing Chess, Practice Yoga, Taekwondo, Gym.
• Reading Spiritual Books.
• Reading magazine of Pharm & Biotech express.
• Reading pharmaceutical guidelines.
COMPUTER PROFIENCY:
• Proficient in MS Office (Power Point, Excel, Word etc.)
• C Programming
EXTRA CURRICULAR ACCOLADES:
• Awarded as Best Alumni from SOA University, Bhubaneswar behalf of Center of Biotechnology in the
4. year 2015.
• Got Silver coin From Zydus Cadilla Healthcare Ltd for actively participate in Annual function as well
as sports in 2015.
• Won 2nd prize in “Safety quiz" contest held at Calyx Chemicals & Pharmaceutical Ltd. ’in the safety
month in the year 2013.
• Participate State level fight in Taekwondo in the year 2012.
• Won 1st prize in “Chess at college level competition” in the year 2010.
• Attended international conference on Biotechnology advances: Omics approaches & way forward
(ICBA-2012)
LEAVE PERIOD:
• Notice Period 1 month.
PASSPORT DETAILS:
• NO :- M6701107
• RPO:- Bhubaneswar
• DOI :- 04/2015
• DOE:- 04/2025
• Pan Detail:- BCFPR5230K
PERSONAL DETAILS:
Father’s Name : Jayakrushna Rout
Date of Birth : 3rd
may 1991
Gender : Male
Marital Status : Unmarried
Nationality : Indian
Languages Known : Odiya, Hindi & English
Religion : Hindu
PERMANENT ADDRESS:
At : Gujadiha
Post : Singakhunta
Ps : Soro
Dist. : Balasore
State : Odisha
Pin no : 756045
DECLARATION:
5. I hereby declare that the above information is true to the best of my knowledge and belief. I hope that you may
give me a chance to serve under your keen and loving guidance.
Date:
Place: Signature:
Nilambar Rout
6. I hereby declare that the above information is true to the best of my knowledge and belief. I hope that you may
give me a chance to serve under your keen and loving guidance.
Date:
Place: Signature:
Nilambar Rout