Quality Assurance Manager

RESUME

Nandkishor B. Adhao.

***, ****** *****, ********, *******.

Cell No. : 096********

E mail: **********.*****@*****.***

*******@*****.***

SNAP SHOT

-Currently working at Sun Pharmaceutical Industries Limited, Vadodara (Gujarat) as Manager in Manufacturing Science &Technology department.

-Leading the global implementation of Cross-Contamination Risk Management in multiproduct manufacturing facilities of Sun Pharma.

-Implementation of Health based limits (ADE/PDE) Cleaning Validation.

-Implementation software based (Documentum) issuance, retrieval and control of formats.

-Proficient in Cleaning Validation, Process Validation, HVAC/Equipment/Area/Utility Qualification, Quality Management System, cGMP maintenance on shop floor, Master document Preparation like MFR, BMR & BPR, Computer System Validation, PLC/HMI verification, Life cycle management of Product and Equipment.

-Gap assessment of site practices with respect to current regulatory standards, warning letters, GMP Trends, observations made by various regulatory agencies during inspections at Sun sites.

-Initiation of Global CAPA based on gap assessment and effective implementation at sites.

-Review of audit reports of regulatory agencies, customer audits, and corporate audit team; assist the sites in response preparation.

EDUCATIONAL QUALIFICATION

M.Pharm.in Quality Assurance (68.29%). from Sharad Pawar College of Pharmacy, RSTM Nagpur University (M.S) Year 2005-2007.

B.Pharm. (60.50%) from Nagpur College of Pharmacy, Nagpur University (M.S) Year 2001-2004.

D.Pharm. (74.80 %), M.S.B.T.E. Mumbai.

PAPER/POSTER PRESENTED:

1. Preparation and evaluation of Metformin hydrochloride microcapsules

Presented in: National Convention-Association of Pharmaceutical Teachers of India

Conducted by: University department of Pharmaceutical sciences, Nagpur in Sept .2005

2. Bio-degradable antibiotic implants for post-operative site delivery

Presented in: National symposium on Current Trends in Drug Designing

Conducted by: Sharad Pawar college of Pharmacy, Nagpur, in Sept. 2006

SEMINARS/CONFERENCES ATTENDED:

National Convention-Association of Pharmaceutical Teachers of India

National symposium on Current Trends in Drug Designing.

Two days training programme on “Validation Techniques” by Jaysheel Hegde.

Two Days training program on “Cleaning Validation” by Mr. Atul Shirgaonkar.

PROFESSIONAL EXPERIENCE

Areas of Exposure (Corporate Quality)

Active participation in development and execution of cross containment study at Sun Pharma Sites.

Development of Cleaning Validation policy as per EMA guidance- Guideline on setting health based exposure limits.

Review of Audit readiness of sites and assistance in audit preparaton.

Review of Quality Metrics reports, site response for regulatory, customer audits.

Active participation in computer software validation FMS based on Documentum.

Review of warning letters and gap assessment with current quality systems.

Preparation of CAPA, Directives based on audit observations, consultant inspections etc.

Areas of Exposure (Related to Quality Assurance activities)

Monitoring the cGMP in plant & maintaining the areas.

Hold Time Study

Preparation, revision & issuance of SOPs & protocols.

Preparation and Review of MFR, BMR & BPR.

FMEA based risk assessment for processes.

Compliance of internal and external audit observation.

Ensuring adequate transfer of systems and documentation to all new facilities.

Areas of Exposure (Related to Validation activities)

Process Validation of Commercial batches and exhibit batches

Cleaning Validation

Equipment Qualification

HVAC Qualification

Area Qualification

Temperature mapping

Training on validation documentation.

Investigation & report preparation in case of failure during the qualification.

Documentation/Quality Compliance

Ensuring compliance of various quality measures by maintenance of appropriate requisite documentation.

Preparation of Process validation protocol, Cleaning Validation Protocol, execution of activity with coordination of Production, Quality Control and IPQA department.

Prepare / Review of VMP, DQ, URS, FAT, IQ, OQ and PQ documents.

Preparation and execution of the Revalidation Protocol, Validation Schedule, Calendar and maintaining their records

Preparation and review of Master Calibration Schedule and follow-up for calibration activities for instruments, gauges etc.

Review of Validation data, compilation of report and preparation of recommendations based on the validation data.

Actively participated in preparation for regulatory audits like WHO-India & WHO-Geneva, ANVISA-brazil, MHRA and USFDA.

EXPERIENCE DETAILS

Cleaning validation (Tablet, Capsule, Dry syrup).

Protocol Preparation, Execution of Cleaning validation and compilation of result.

Selection of critical swab sample points and to prepare justification for selection of swab locations.

Review of cleaning validation documents. Assessment of new product as per worst case criteria.

Periodic review for the worst case product selection.

Coordination with Q.A., Q.C., and Production for execution of activity.

Cleaning verification of Exhibit batches.

Equipment Qualification

Coordination with Engineering, Production and QA activity.

Preparation, Review and execution of DQ/ IQ/OQ/PQ protocol & report of equipments in the solid oral facility (like RMG, FBD, blender, compression machine, Auto coater, Bottle packing line, Induction sealing machine).

Review of Equipment Operation and Cleaning SOP for correctness.

Ensuring the recommendations based on qualification are captured in SOP/BMR/BPR.

Review of PLC validation/HMI verification.

Facility Validation (Utility & Area Qualification)

Preparation, Review and execution of validation of utilities such as HVAC System and Compressed air.

Review, updating and ensuring facility set up, drawings such as area classification, area differential pressure, air flow direction, AHU location, man & material movement, civil lay out, purified water generation and distribution system.

Preparation of Area qualification protocol and Report.

HVAC Qualification

Monitoring & review the all test parameters reports of HVAC validation

Air velocity measurement & air changes per hour in room, Filter integrity test

Air flow visualization test, Duct leakage test,

Environmental monitoring- Physical parameters (Temperature, RH and differential Pressure of Room), Non viable particle count & microbial monitoring),

Room Recovery test, Power failure test

Illumination level measurement

Process validation (Tablet, Capsule, Dry syrup).

Preparation of process validation SOP, protocol, sampling plan.

Provide training to all concerned personnel and Co-ordination with different departments for execution of process validation & cleaning validation protocol.

Monitoring & Sampling at all stages of process validation & cleaning validation batches.

Compilation of data and report preparation as per regulatory requirement.

CARRIER SUMMARY

Company

Designation

Experience

Sun Pharmaceutical Industries Limited

Manager – MSTG

May 2014 to till date

U.S.V. Limited. Daman

Sr. Executive – Quality Assurance

July 2013 to May 2014

Wockhardt Ltd., EOU Tablet, Biotech Park, Aurangabad, Maharashtra.

Sr. Officer-Validation

Dec. 2010 to July 2013

Glenmark Pharmaceuticals Pvt. Ltd., Nasik

Sr. Officer – Quality Assurance

Aug .2009 to Dec 2010.

Flamingo Pharma Pvt. Ltd. Taloja, Mumbai

Officer – Quality Assurance

Jan. 2009 to July 2009

Cipla, Patalganga, Mumbai

Management Staff - Quality Assurance

March.2008 to Nov.2008

Sekhsaria Chemicals Private Limited

Trainee officer - Quality Assurance

Sep.2007 to Mar. 2008

DECLARATION

I hereby declare that the above-mentioned information is authentic and true to the best of my knowledge.

DATE: . PLACE: .

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