Bhumika DC

http://www.linkedin.com/in/bhumikadcwww.linke

**** ****** ***** #**** 347-***-****

Irving, TX acvnhm@r.postjobfree.com

SUMMARY:

Over 5 years of experience in Pharmaceutical Industry in accordance with FDA regulations and company policies and procedures.

As a QA analyst in areas like Method Validation, Method Development, Equipment validation in accordance with FDA regulations and company policies and procedures.

As a QC analyst tested and calibrated analytical tests using instruments such as HPLC, IR, UV, KF, Refractive Index, wet chemistry technique (titrations & heavy metals) and dissolution system.

As a Production Scientist knowledge about supervising staffs, comprehensively familiar with pharmaceutical productions-fabrication process, elementary process, GMP process and In Process Quality Control.

Prepared Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR), Potency calculation of formulation.

Familiar with Electronic Document Management System (EDMS), Track wise (Change Control, CAPA, Complaint Investigation workflows), Root Cause Analysis (RCA), Laboratory Information Management System (LIMS).

Knowledge about Total Quality Management (TQM), Quality Risk Management (QRM), Risk assessment, ICH Guidelines and Regulatory Affairs.

Experience in drafting/updating/reviewing the following validation lifecycle deliverables User Requirements Specification (URS), Master Validation Plan, Qualification Protocols, IQ/OQ/PQ, Deviations, and Summary Reports.

Familiar with FDA regulations, GxP (GCP/GLP/GMP) guidelines and work experience with 21 CFR Part 11, 820, 210 and 211.

PROFESSIONAL EXPERIENCE

Izeen Pharma Inc., Frederick, Maryland (Jun 2015–Feb 2016)

Quality Assurance Analyst

Reviewed and checked stability chart recording file of Real time and Accelerated stability.

Preparation, review approval, distribution and management of controlled documents or revised QA SOPs.

Approved incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.

Assignments of part number, product code and NDC number of product.

Ensured that the procedures and specifications of firms under contract are also appropriate and releasing of finished product with third party.

Requesting and completing of change request.

Knowledge of validation master plan, IQ, OQ, PQ, and ICH regulations.

Generation, issues and review of Manufacturing Batch Record (MBR), Batch Manufacturing Record (BPR) and assignment of batch number.

Material status Change Notification (MSCN).

Room/Area and Equipment clearance for GMP associated manufacturing operations.

Assist in the development and implementation of effective CAPA, Deviation and RCA analysis management that support company objectives.

To ensured in-process controls are performed during manufacturing operations and results are satisfactory or not and, if necessary, adjust the process to ensured that the product conforms to its specifications.

Served as a technical liaison with other departments, vendors or contractors, and QC teams as well as participated in interdepartmental meetings as assigned.

Deurali Janta Pharmaceuticals Pvt Ltd, Nepal (Nov 2009–Aug 2014)

(ISO 14001, ISO 9001 and WHO GMP CERTIFIED).

Production Scientist (Nov 2013–Aug 2014)

Experienced and worked in complete cGMP environment on API's, drug manufacturing, pharmaceutical composition, formulation process, Packaging and In process Quality control.

Involved in process of giving intimation to QC for sampling and analysis and procedure of writing for swab test of penicillin and cephalosporin product.

Performed documentation, including preparation and revision of Batch Manufacturing Record and Batch Packaging Record of drug formulations.

Verified maintaining cleanliness of change room and assigned line clearance certificate.

Responsible for filling of ‘Remarks’ and ‘Deviation’ especially during the manufacturing process loss and packaging process loss if the expected yield falls outside the limit.

Performed counter checking of the dispense active pharmaceutical ingredient and starting material.

Knowledge about hydration and compounding of liquid syrup, suspension, mixing and lubrication of powder during tablet formulations.

Monitored and involved in mixing of Dry syrup or suspension in both Penicillin and Cephalosporin section.

QA Analyst (Aug 2012–Oct 2013)

Validated analytical laboratory equipment and developed summary reports such HPLC, UV –VIS, in compliance with FDA regulations.

Participated for internal process audits to ensure compliance to quality management system requirements and relevant standards and SOPs.

Worked with all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the company maintains a state of readiness for inspection by Regulatory agencies.

Involved in Change Control Processes in reviewing and approving change controls and handle market complain investigations.

Developed validation plans, qualification protocols, risk/regulatory assessments, and validation reports and released memos.

Collaborate with customer group (Validation, Engineering, Facilities, IT, QC) to ensure quality systems are monitored and established metrics are met.

Approved or rejected production batch records and make the final decision to release a product lot into commerce.

Developed qualification and Validation Summary Reports for Lab and manufacturing equipment

Performed ER/ES assessment for equipment in Analytical laboratory.

Controlled, monitored and checked the quality of the product as it is processed and up to completion of manufacturing i.e. begins with raw materials and component testing and includes in-process packaging, labeling and finished product testing as well as batch auditing and stability.

Conducted manual testing, compared actual results with expected results and reported defects while installing new equipments.

QC Analyst (Nov 2009- Jul 2012)

Analyzed and carried out analytical test using instruments such as HPLC, IR, UV, KF, Refractive Index, wet chemistry technique (titrations & heavy metals) and dissolution system to meet the standards required for cGMP operations.

Ensured that all samples are tested in accordance with written standard procedures and revised Standard operating procedures (SOP) to describe QC activities.

Analyzed in-process, raw material, intermediate, and finished packaged products in compliance with authorized test procedures and relevant reference literature i.e. Pharmacopoeias (USP, BP and IP).

Identifies and troubleshoots equipment problems and reviews data obtained for compliance to specifications and reports abnormalities.

Trained other analysts, lab assistants, and freshly graduated pharmacists on Good Documentation Practices and laboratory procedure.

Ensured that laboratory productivity and goals are met through timely completion as specified by the production and other departments.

Performed in sampling of raw & active materials, bulk and finished product by sampling tool.

Conducted testing on packaging materials, bottle labels, stability testing of finished products and research samples.

Changed internal SOPs, recommending modifications for SOPs, reviewed and edited documents, protocols, product reviews, change controls.

Developed secondary reference standards from primary standards and assisted in the management of product retain and reference standard inventories and distribution request.

Ensured that laboratory equipment’s are calibrated or verified / prior to use.

Developed and qualified new testing methods and techniques.

Authorized in establishing the transfer of methodology from R&D department.

EDUCATION

Kathmandu University, Dhulikhel, Nepal (Internationally Collaborated University)

http://www.ku.edu.np/university/

Masters in Pharmaceutical Science 2011-2013

Thesis: Formulation and Invitro Evaluation of Vinpocetine sublingual tablets by inclusion complexion with ternary kneaded system

Bachelor of Pharmacy 2005-2009

Thesis: Formulation of Mouth dissolving Tablet of Famotidine and comparing with Lyophilized Famotidine

TECHNICAL SKILLS

Computer: Microsoft Office, MS Excel, PowerPoint, and Minitab 16.0.

Quality Tools: DOE, SWOT Analysis, Gantt chart

Languages: English, Nepali, Hindi, Urdu (spoken only)

PROFESSIONAL TRAININGS AND SEMINARS

In plant Training about pharmaceuticals manufacturing in Deurali Janta Pharmaceuticals Nepal. (2009)

Seminars about Analytical Method Validation in Deurali Janta Pharmaceuticals Pvt Ltd, Nepal (2012)

Attended Seminars on Total Quality Management in Kathmandu University (2012)

Recent Pharmaceutical Technologies” held by Nepal Pharmaceuticals Association (2014)

WORK AUTHORIZATION: U.S. Permanent Resident (Green card)

References provided upon request

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