Quality Assurance Management

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

Mobile No.: 081********, 088********

OBJECTIVE

To seek challenging position that offer opportunity to explore my qualification, experience and skill in the quality assurance department of pharmaceutical industries, in such organization that provide a work environment that foster teamwork and allows independent responsibilities.

JOB STATUS:

Currently joined company:

Renown Pharmaceutical Pvt. Ltd., Ranu, Vadodara, Gujrat. – As a senior executive QA

Duration – August 2013 to till date.

(TGA Approved plant and plan for MHRA & USFDA audit)

Previous company Experience:

Lupin Ltd., Pithampur, Indore - Executive – quality Assurance (hormonal section of solid dosage - Tablets)

Duration – August 2011 – Aug 2013 (USFDA and MHRA approved plant).

OKASA PHARMA PVT. LTD., Satara (under the guidelines of CIPLA)- Q.A. Officer (Solid dosage form – Tablets & Capsules)

Duration - Aug. 2010 to July 2011.

(TGA Approved Plant)

Themis Labs. Pvt. Ltd. (Inventia Healthcare), Thane - QA trainee (Solid dosage form – Tablets & Capsules)

Duration - June 2006 to Sep. 2007.

EDUCATIONAL PROFILE

M. Pharm. (QA) : Institution of Pharmaceutical Education & Research, Wardha in 2007- 2009, Secured 69.83%

B. Pharm.: S. K. Bhoyar College of pharmacy, Kamptee in 2003-2006, Secured 67% marks.

HONORS AND AWARDS

Qualified in GATE-2007 with 83% percentile.

Research Fellowship from AICTE, Mumbai for postgraduate studies.

Responsibilities Handled

Quality Risk Assessment

Responsible to Implement and carry out Quality Risk Assessment at formulation site associated with equipment, procedures and systems as per ICH Q9 guidelines.

Internal &external Audits:

Responsible for preparation of internal Audit schedule and to carry out internal audits in production, Warehouse, Engineering and QC departments. Fulfil the non-conformance as per GMP with proper change management and CAPA management.

Responsible to carry out self-inspection in QA department to ensure the GDP and online documentation.

Preparation for the audit of USFDA, MHRA, SANDOZ and QP.

Quality Management System

SOPs:

Responsible for preparation and review of standard operating procedures (SOPs) related to QA, production, engineering department and distribution and retrieval of the same.

Responsible to conduct SOP training before implementation in related departments.

Responsible to monitor distribution and retrieval of SOPs.

Review of documents:

Responsible for review of master of intended and commercial BMR, BPR and QC data prior to batch release.

Responsible for review of SOPs.

Responsible for preparation and review of site master file.

Simplification of SOPs, BMR and BPR as per regulatory requirement.

Investigation

To monitor change control, deviations, market complaint, incident and OOS. To perform the failure investigation of the same with proper CAPA and to ensure the proper close out within specified timeline.

Annual product Quality Review (APQR)

To prepare APQR in coordination with production and QC departments

Validation & Qualification

To prepare and review qualification protocol and reports of equipment like blister packing machine, wallet packing machine, checkweigher, OCR and BCR scanner, Pharma check for tablets.

To carry out process validation and cleaning validation. Compilation and review of report.

To ensure periodic calibration activity by external calibration agency

Monitoring the IPQA activities in manufacturing and packing area.

Line clearance at different stages of manufacturing and packing of solid dosage form like dispensing, granulation, medicament preparation, compression, coating & packing

Retention Sample Management in SAP.

Sampling at blending stage, compression stage, AQL sampling at Compression, coating and packing stage.

Handle the project for the simplification of SOPs, Batch Records, and Reduce the Rejection of Packing Material during Activity by the preparation of trend analysis.

Other Skills

Expert in Computer knowledge, easily understood software required for pharmaceutical industry & Typing (passed 30 wpm English).

TRAINING PROGRAMMES ATTENDED

National Symposium on “Chromatography: An important tool for herbal pharmaceutical industry” organized by Association of Pharmaceutical Teachers of India and Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha, M.S.

PERSONAL PROFILE

Nationality : Indian

Date of Birth : Feb. 26, 1984.

Marital status : Single

Languages known : English, Hindi, Marathi

Communication address : Shree Chandra complex, near N. N. Bank, Juni oli, Kamptee (M.S.).

Current Address : C/o. Mr. Nilesh Solanki, Behind Vadodara Central Mall, Wadiwaadi, Alkapuri, Vadodara

I, the undersigned, certify that all the information provided by me is true to the best of my knowledge and beliefs.

Date:

Place: Vadodara (SANDEEP P. NAGPUREY)

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