Quality Assurance Manager

CAREER OBJECTIVE

> Comprehensive Knowledge in ICH Guidelines and CFR 210 & 211

> Worked in Quality Assurance department of organizations having cGMP

and regulatory compliance

> Have audit exposure to multiple regulatory agencies. Willing to

travel. Willing to relocate.

> Self-motivated, detail oriented, and good industrial and

interpersonal skills.

> To associate with an organization where I can utilize my knowledge and

skills which will help to improve my potential as well as the

organization

EDUCATIONAL QUALIFICATIONS

> Completed B.Pharma (First Class) from Utkal University in 2009.

> Completed D. Parma(First Class) from I.MT.,Puri

EXPERINCE

Olive Healthcare, Daman, India (US FDA Approved)

Senior Quality Assurance Officer (Documentation) From July 2011-

Present

Baader schulz lab, Daman, India (WHO GMP, NAFDC Approved)

QA Officer from( Jan-2010 to July-2011)

JOB PROFILE (OLIVE HEALTH CARE)

> Preparation of Batch Manufacturing Record

> Preparation of SOP.

> Handling all the documents related to Vendor

> Controlling Documentation issuance and retrieval

including BMR, SOPs, and other

controlled Documents.

> Actively Participating during Process validation

> Preparing the Internal Audit schedule and coordinated

with the team for Self Inspection.

> Preparation of APQR

> Preparation of MFR

> Checking of Art Work

> Investigation of Incidence and implementation of the

corrective actions.

> Investigation of market complaint, preparing the

response for the complainant and closure of

the Market complaint through proper Documentation

> Evaluation and Closure of Deviation with proper

Documentation

> Evaluation and Closure of Change control with proper

Documentation

> Responsible for preparation, execution of validation

protocols and preparation of

validation report

> Assist to prepare VMP,SMF & Dossier

> Preparation of Specifications of finished Product.

> Periodic Monitoring of control samples and their

Documentation

> Regularly Monitoring the Qualification Activity.

> Handling all the documents related to Vendor.

Reporting to Manager QA

JOB PROFILE (Baader Schulz Lab)

> Preparation of Batch Manufacturing Record

> Maintain record in Log Book of all Issued BMR & BPR

issue

> Preparing Annual Product Review

> Checking of Art Work

> Preparation of Specifications of finished Product

> Issuance of Specification and Controlled SOP.

> Issuance of Log Books And Annexure Formats and Party

Documents.

> Maintaining Record of all Control Samples Details.

> To perform in process checks at various Manufacturing

Stage

> To give line clearance at various manufacturing stage

> To collect and send sample to QC for analysis

> To release the product for next stage after receiving QC

release report

> Collect control sample and Stability sample

> To ensure correct labeling at various stages of

manufacturing

> To collect and analyze swab/water samples

> Operating and calibration of IPQA instruments

> Maintenance of log book and documents control.

Reporting to Asst-Manager QA

AUDIT FACED

> USFDA

> WHO GMP

> ISO

> NAFDAC

AREA OF INTREST

> QMS

> VALIDATION

> STABILITY

> TRAINING

HONORS AND ACHIEVEMENTS

> Awarded as Best Employee from the Month of July-September 2012

> Got the First prize in the quiz Competition for the Year 2012

> Awarded as Best Attendee for QA From October-December 2011

MY STRENGTHS

> Confident, smart working, positive Attitude, Co-operative and

Dedicated.

> Able to work independently or in a team producing results within

a time frame.

> I am a good strategist and having the commanding power

PERSONAL PROFILE

Name : Partha Tathagat Dash

Father's Name : Mr. Manamohan Dash

Nationality : Indian

Date of Birth : 14th May 1984

Gender : Male

Language Known : English, Hindi and Oriya

Daman

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Date :25/04/2013

Partha Tathagat Dash

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