SUBHAM BANERJEE

Contact No.: +919*********

E-Mail: acsgce@r.postjobfree.com

Seeking assignments in Quality Assurance of a pharmaceutical organisation of high repute.

PROFILE SUMMARY

Offering 5.5 years of professional experience in Pharmaceutical and ITeS industries.

Domain expertise entails formulation development and drug regulatory guidelines.

Abilities in development and validation of pharmaceutical formulation and process.

Exposure in different aspects of pharmaceutical quality assurance documentation.

An effective communicator with excellent interpersonal and analytical skills.

TECHNICAL SKILLS

Instruments handled – UV spectrophotometer, FTIR, Tablet disintegration test apparatus, Tablet friability test apparatus, Tablet hardness tester, Leak test apparatus, Digital vernier caliper, Digital pH meter and Electronic balance.

Exposure in handling various laboratory scale formulation manufacturing equipments.

Conversant with Microsoft Office package and Internet tools.

Operating Systems – MS Windows 7 and 8.

Well versed with pharmaceutical formulation development and quality assurance.

EMPLOYMENT DETAILS

February 2012 – July 2015: Martina Bio Genics Pvt. Ltd. (Kolkata) as

Officer – Research and Development

Job Responsibilities:

oTo conduct literature review, different patent search and preformulation studies.

oTo develop, monitor and validate new formulations and provide support for existing products.

oTo conduct the trouble shooting of formulations in terms of composition and process issues.

oTo generate and revise various documents like standard operating procedures, formats, protocols, reports, master formula records, etc for the formulation development laboratory.

oTo conduct development trials, achieving desired dissolution profile and manufacturing the stability batches and bioequivalent batches.

oTo carry out the stability studies as per the relevant procedures and protocols.

oInteraction with sales and marketing team, quality and production department to resolve quality related issues.

oTo provide technical support in the commercial batches as and when required.

oWell conversant in operation and calibration of different laboratory analytical instruments and laboratory scale formulation manufacturing equipments.

March 2010 – March 2011: Datacore India Pvt. Ltd. (Kolkata) as

Functional Team Leader

Job Responsibilities:

oMaintain electronic medical records database and manage patients' health information data.

oCodify patients' medical information for reimbursement purpose.

oReview patient records for timeliness, completeness, accuracy, and appropriateness of the abstracted patient data.

oProtect patients’ health information for confidentiality, authorized access for treatment

and data security.

oCommunicate and provide EMR customization requirements to the offshore team.

oEvaluate clients’ workflow, documents and procedures for EMR implementation and customized training.

oParticipate in the evaluation of team members’ level of performance and to provide performance management.

oEnsure training, documentation, policies and procedures are up to date, compliance and consistent across the project.

October 2009 – February 2010: Sun Knowledge Pvt. Ltd. (Kolkata) as

Clinical Analyst

Job Responsibilities:

oProvide on call clinical support to the overseas beneficiaries of a health insurance company as per their respective formulary plans and suggesting formulary alternatives.

oReceiving inbound calls of beneficiaries, caregivers, physicians and pharmacies and maintenance of beneficiary database in the client software.

oReview Medicare Part D coverage determination requests according to the established treatment protocols, clinical criteria and member benefits.

oConduct the drug utilization review and Medication Therapy Management programs to meet Medicare Part D and HIPAA requirements.

oDefine and coordinate prior authorization issues and investigate fraud and abuse reporting.

oDefine business requirements and manage implementation of new CMS requirements

oProvide clinical guidance, support and oversight to the assigned pharmacy technicians.

August 2006 – March 2007: Srushti Pharmaceuticals Pvt. Ltd. (Bangalore) as

Quality Assurance Executive

Job Responsibilities:

oPreparation of validation master plan, site master file and quality manual.

oPreparation of standard operating procedures, standard test procedures, process validation protocols and summary reports.

oTo conduct the qualification and validation of the instruments and equipments.

oActive participation in regulatory inspections like Schedule M and WHO GMP.

oTo control the inventory of control samples.

oPerforming in process quality assurance checks.

oIssuing of line clearance at every step of batch manufacturing.

oDocumentation of log books, calibration records, temperature and humidity records.

oConduct internal quality assurance audits.

oHandling of change control, product recall and vendor validation issues.

EDUCATION

M. Pharm (Pharmaceutics) from Calcutta Institute of Pharmaceutical Technology & AHS, Uluberia (West Bengal University of Technology) in 2009 with 78.70% marks.

B. Pharm from Acharya & BM Reddy College of Pharmacy, Bangalore

(Rajiv Gandhi University of Health Sciences) in 2006 with 72.14% marks.

Advance Diploma in Information Technology Application from Youth Computer Training Centre, Rampurhat in 2015 with 83.00% marks.

12th (Science) from AG Church School, Ukhra (ISC) in 2001 with 69.30% marks.

10th (Science) from AG Church School, Ukhra (ICSE) in 1998 with 75.20% marks.

DISSERTATION WORK IN M. PHARM

Product development studies on design and evaluation of Salbutamol Sulphate microspheres, using Ethylcellulose as the polymer and solvent evaporation as the preparation technique.

EXTRA CURRICULAR ACTIVITIES

Class topper while pursuing M. Pharm and B. Pharm curriculum.

Life member of Indian Pharmaceutical Association, Mumbai.

Trained in international and national pharmaceutical regulatory guidelines by CDSCO (North Zone) and NIPER (Mohali).

PERSONAL DETAILS

Date of Birth: 03/02/1982.

Languages Known: English, Hindi and Bengali.

Address: 19/7, Jahura Bazar Lane, Kasba Rathtala, Kolkata – 700042, West Bengal.

Nationality: Indian.

Marital Status: Single.

Hobbies: Sports and Music.

DECLARATION

I hereby declare that the particulars furnished above are correct and true to the best of my knowledge and belief.

Date:

Place: (SUBHAM BANERJEE)

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