Quality Assurance Manager

Objective:

To work in a professional and result oriented environment and look for

continuous growth and learning opportunities, preferably in a progressive

and competitive work culture in a research driven company and to contribute

to pharmaceutical Industry.

Working Experience:

. Presently working in Quality Assurance department in Cipla Ltd. and

having 7 years' experience, from April 2007 to Till Date. Having

Exposure in Tablet, Capsules and Nasal Spray.

. In Goa Location 3years and 3 months and in Sikkim Location from

Aug.2010 to till date.

Current Designation:

. As a management staff in USFDA (Apr 2009), MHRA (Jun 2008) WHO (Mar

2008 and Feb 2009), TGA (Nov 2007) and MCC (Dec 2009) approved

facility of Cipla Ltd, Goa from Apr. 2007 to Jul.2010.

. Working as Section Head of QA Documentation and Responsible for all QA

activities in absence of QA Manager at Cipla Ltd., Sikkim.

Current Job Profile:

> Handling of Market Complaints.

> Review of Change Control.

> Review of Deviation and CAPA

> Handling of Batch failure Investigation.

> OOS/OOT Investigations and review.

> To perform Risk Assessment Study

> Handling of Raw material and Packing material Rejection

> Approval of Batch Release.

1. Handling of Market Complaints:

V Handling of Market Complaint, Complaint investigation, Preparation of

complaint investigation report and approval of the same.

V Handling Product Recall.

V Coordination with other department for CAPA's and Compliances.

V Preparation, Training and execution of general study protocol related

to market complaints.

V Co-ordination with Production, QC, Packaging department with respect

to complaints investigation, CAPA and product recall (if applicable).

V Preparation of the Complaint trends and complaints summary reports.

V Responsible to impart training on market complaints received related

to Quality Defects.

2. OOS/OOT Investigation and Review:

V Review of Investigation of OOS results, summary of manufacturing

review. Evaluation and approval of batch failure.

V Investigation of OOT results, by 5 sigma or 3 sigma tool, related to

the product analysis by co-ordination with the production.

V Review and approval of OOT investigation report.

3. Review of Change Control, Deviation and CAPA:

V Review of Change control related to product, facility, system and

document, approval from concerned department and corporate QA (if

applicable) and ensure closeout within due time. If delay review of

rational behind it.

V Review of Deviations, evaluation of proper root cause by fish bone

diagram and why-why analysis and effective CAPA with impact

assessment.

V Review of Deviation trend analysis and evaluation of repetitive

deviation (if any).

4. Handling of Raw material and Packing material rejection:

V Review of OOS investigation and responsible for coordination with

purchase and corporate QA for effective CAPA from supplier end.

V Responsible for getting CAPA review from corporate QA and closeout of

rejection within time frame.

V Responsible for rejected material management and to ensure proper

segregation and labeling on rejected material.

5. Review of Master Documents:

V Review of Master Batch Manufacturing Record, Batch Packaging Record,

Validation protocol and packaging protocols.

V Review of validation report and summary report.

V Review of Annual Product Quality Review (APQR).

6. On shop floor:

V To ensure all activities at shop floor are performed as per cGMP

norms.

V To monitor in-process activities (Sampling, Line Clearance, In-process

Checks and Calibration of IPQA instruments).

V To ensure the review of batch manufacturing record and batch packaging

records of validation as well as commercial products.

V Responsible for risk assessment study of new products and periodic

review of risk assessment of existing products and equipment.

V Monitoring of production operations and suspending any operation that

is not in compliance with applicable SOP's, specification or written

procedures of batch document.

V Responsible for periodic review of SOP's and qualification documents.

V To ensure validation and stability samples are withdrawn in time.

V To conduct the self-inspection and/or quality audit that regularly

appraises the effectiveness and applicability of the quality assurance

system.

V To assure that appropriate calibration and preventive maintenance of

manufacturing equipments and laboratory instruments are conducted as

scheduled.

V Participation in vendor audit for vendor qualification.

V Control on batch release system i.e. assembling and review all

documentation related to the processing, packaging and testing of each

batch of the product before authorizing for sale. And responsible for

batch release approval.

V Co-ordination with the Production Department for new product

application to FDA also all other applications to FDA related to

Certificates of Pharmaceutical products, Free Sale Certificates,

Export certificates, GMP Certificates, etc.

Participated in customer Audits:

V Sandoz - Germany, Kyorin Remedio - Japan, Pharmascience - Canada, Teva

- US, Perrigo - US and Neolab - UK.

Professional Skills:

V Adaptivity with the environment.

V Adaptivity with coordinator.

V Adaptivity and flexibility with the changing system.

Qualification Details:

* Diploma in Pharmacy passed from Bangalore, with 62.17% in the year

2000.

* Bachelor in Pharmacy passed from Bangalore, with 60.81% in the year

2004.

* Master of Pharmacy (Pharmaceutics) passed from Vinayaka Mission's

College of Pharmacy, Salem (T.N.) with 65% in the year 2007.

. M.Pharm project entitled "Formulation and Evaluation of

Gastroprokinetic Itopride Hydrochloride Floating Tablets" carried out

from R&D division of Micro Labs Pvt. Ltd., Hosur, T.N.

Personal Profile:

Date of birth : April 10th 1979

Sex : Male

Marital Status : Married

Language Known : English, Hindi, Bengali

Strength : Honest, Confident, Hard working, Punctual to

work.

Current address: Permanent Address:

IBM Colony, S/O Mr. Kali Charan Dutta

Rangpo, East Sikkim Vill + PO - Simulia

Sikkim - 737132 Murshidabad - 713123 (WB)

Declaration:

I solemnly declare that the above information is true and correct to the

best of my knowledge.

Atanu Dutta

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