CAREER ASPIRATION

My career goal is to obtain broad base of experience in pharmaceutical industry and looking forward for a suitable position in a dynamic work environment where I can utilize my experience, skills and expertise gained over the years to achieve organization objective and career growth. INTERESTED SKILLS & EXPETISE:

• Familiar with cGMP, 21 CFR guidelines and its regulatory Compliance.

• Regulatory Audits Handled- USFDA, MHRA, MCC, WHO, TGA, FDA etc.

• Preparation of SOP’s, Summary reports, presentations & Qualification protocol.

• Expertise is Root cause analysis, Impact assessments, and its documentation.

• Development and implementation standard operating procedure(sop) for Quality System required for pharmaceutical products manufacturing, packaging and distribution.

• Manage and oversees procedure for change control, deviation/investigation, CAPA, labeling, retain samples, vendor qualification, customer complain, batch packing records, stability studies, Regulatory agency inspection, product recall &Annual product Quality Review(APQR)

• Online review of BMR, BPR and Protocols

• Review and collection of different documents from plant for Regulatory submissions.

• Maintain documentation of compliance activities and file appropriate compliance reports with Regulatory agencies.

• Ensure customer complaints are timely investigated and adequate CAPA is implemented.

• Working as a training coordinator and giving the training to new employees. CAREER SUMMURY:7 Years Experience

Worked with Lincoln parenteral limited(sterile)Ahmedabad. as Sr. executive Quality Assurance from july 2018 to February 2019

Worked with MYLAN LABORATORIES LTD,Sff, Bangalore. as Sr. Associate Quality Assurance from July 2015 to June 2017.

Worked with Lincoln parenteral limited,Ahmedabad. as executive Quality Assurance from Aug 2014 to july 2015

Worked with Micro Labs Limited (oral dosage form), GOA as Officer Quality Assurance from October 2012 to July 2014

Worked with in Marksans Pharma Limited (oral dosage form), GOA as Officer Quality Assurance from July 2011to October 2012

JOB & RESPONSIBILITY IN MYLAN LABORATORIES LTD:

• handle change controls, Incidents, investigations and CAPA using trackwise. To coordinate with the cross functional team for any changes and assess the impact on the shop floor.

• Trending and Preparation of Change controls, Deviations, CAPA & Quarterly metrics of visual inspection of qualification & Requalification protocol.

• Involve in audit compliance – preparation of response, involve in implementation of CAPA’s proposed within the timeline given line clearances for Dispensing, X-ray, Leak test, Visual inspection and Packing.

• Performing in process QA activities in Dispensing, X-ray, Leak test, visual inspection packing.

• Monitoring and verification of all online critical activities and documentation.

• routine inspection for various departments to maintain GMP compliance at all levels. SABITARANI SAHOO

Bachelor in Pharmacy. Mobile No: +1-262-***-**** E-Mail: ad2les@r.postjobfree.com

+91-798*******

CURRICULUM VITAE

• Preparation of Rogue sample test kit, Qualification and Re-qualification of visual inspectors.

• to develop innovative training solutions to meet the training and developmental needs.

• Successfully implemented My University at for better compliance. JOB & RESPONSIBILITY IN LINCOLN PARENTREAL:

• Giving line clearances for Dispensing, Visual inspection and Packing. & OINTMENT.

• Preparation of protocols related to the Visual inspection, Packing and warehouse.

• Sampling of Finished samples, Control samples & stability samples

• Daily check manufacturing facilities by taking around in the plant and inspect the relevant records at random the parameters.

• Review of master BPR & BMR, also online BPR & BMR.

• Handling of Breakdowns.

• Preparation & Review of qualification document of visual inspector and rouge sample kit. JOB & RESPONSIBILITY IN MICROLABS LTD:

• for collection and review of various documents (Spec, STP, CoAs, Analytical method validation reports, BMRs, BPRs, Stability Protocol and reports etc.) for Regulatory submissions.

• Responsible for overall compliance to Training’s & GMP’s

• Identifying training needs as per JD, analysis and its compliance.

• Preparation of presentations, Training modules, lesson plans, Audio and video Sop’s, Training Calendar and maintain assets of Training division.

• Performance evaluation of Persons involved in Critical activities

• Monitoring Training Performance Metrics and reporting the same to senior management.

• Monitoring the performance of the Training to suggest and implement appropriate measures to improve its effectiveness.

• Examine the effectiveness of established procedures, standards, identify & assisting in their obligation to comply with all regulatory guidelines.

• Review of training Systems as part remediation plan and liaise with Global team in implementation of action items identified as part of continuous quality improvement plan . JOB & RESPONSIBILITY IN MARKSANS LTD:

• Giving line clearances for Dispensing, Granulation, compression, capsule filling, coating and packing

(oral solid formulations).

• Issuance of shop floor related document.

• Handling of Breakdowns and SAP transactions

• Revision of SOP’s

• Responsible for Overall Compliance to Training at Shop floor

• Ensuring Compliance to Procedures by monitoring of shop floor activities

• Responsible for routine inspection for various departments to maintain GMP compliance at all levels.

• Preparation of protocols related to the Packing and warehouse

• Daily check manufacturing facilities by taking around in the plant and inspect the relevant records at random the parameters.

• Monitoring and verification of all online critical activities and documentation

• Preparation and handling of standard operating procedures. AREA OF EXPERIENCE :

• Worked as a Training coordinator

• Regulatory Affairs

• Clinical Research

• QMS (Track wise)

• Handling of QMS elements (Change controls, Deviations, CAPA)

• Handling of Breakdowns and SAP transactions.

• Inspection (X-ray, Leak testing and Visual inspection) & Packing

• Dispensing, Granulation, compression, capsule filling, coating and packing (oral solid formulations).

• Sampling of Intermediate bulks, Finished Product. AUDITS FACED

• USFDA

• GMP AUDIT

• MAX HEALTH CARE, U.K

• VARIOUS CUSTMOR AUDITS - GHANA, GSK, UNICEF, NOVARTIS, ETHOPIA AND SANOFI.

• MCC

• MHRA.

EDUCATIONAL QUALIFICATION

• B. Pharmacy at BPUT University, Odisha with 69%.

• Intermediate (+2) from CHSE Board with 45%.

• S.S.C from Board of Secondary Education with 70%. RESEARCH WORK

• Pharmacognocy effect of Gastric -peptic ulcer.

• Clarity of visual Inspection

ACHIEVEMENTS

• One of the leading team members participated in shop floor activities for USFDA, MCC audit PERSONAL TRIATS

Strong Desire to Learn and Grow

Adaptability

Good Time Management

Can work independently

Confidence

Can work under pressure

PERSONAL DOSSIER

Nationality : Indian

Date of Birth : 12th Aug 1988

Sex: Female

Marita Status : Married

Language Known : English, Hindi, Odia

Address : 1130 Links Ct, Apt#1, Brookfield, Wisconsin, 53005 DECLARATION:

I hereby declare that the information furnished above is true, the best of my knowledge. Sabitarani sahoo.

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