Quality Assurance Training

Arun Joshi

Address: *** ****** *****, *********- *****, CA

Contact: 951-***-****. E-mail: *********@*****.***

Prologue: Nine years of experience in Pharmaceutical Manufacturing with a BS in Pharmacy from India. 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.

EDUCATION:

KMIPScs, Sambalpur University Rourkela, Orissa, India

B. Pharmacy (First Class, GPA equivalent to 4.0/4.0) April 2001

EXPERIENCE

Glenmark Pharmaceuticals Ltd., India

Senior executive, Quality assurance May 2010 – Present

• Documentation cell in-charge, lead a team of 6

• Product Failure Investigation, Compilation of investigation reports and related documents for their closure with prescribed documentation

• Root cause analysis of Quality related issue and Implementation of CAPA (Corrective and Preventive Action) through proper documentation

• Batch record review and final Release of batches for dispatch in SAP system

• Investigation of market complaint, preparing the response for the complainant and closure of the Market complaint through proper documentation

• Investigation of Incidence and implementation of the corrective actions

• Evaluation and Closure of Deviation with proper documentation

• Evaluation and Closure of Change control with proper documentation

• Audit of Contract manufacturers

• Audit of Vendors for Packaging material, Raw Material and Finished Goods distributors

• Audit of service providers such as healthcare, food, and laundry.

• Imparting Self Inspection and assuring implementation of the required change for improvement in Quality System

• Assuring cGMP compliance on Shop floor by solving product related issue and proper co-ordination with other departments for smooth functioning of system

• Preparing training calendar and matrix after assessing individual’s training need and maintaining all the training records

• Planning, co-ordination and conducting training program on cGMP topics as well as on job SOPs training as per training schedule and Calendar

• To develop and train subordinates and trainees to achieve desired performance level

• Ensuring periodic validation and Re-Validation related to process and Equipments/Instruments whenever required

• Co-ordination with Technology Transfer Group, Production and Quality Control for validation of new products

Abbott (Previously Piramal Healthcare Ltd.) India

Executive, Quality assurance Oct 2006 - May 2010

• Was an active member of the team of e-CAPA and CAPA activities for root cause analysis, investigation and implementation of CAPA.

• Was responsible for preparation of response (compliance report) to various regulatory and customer audit observations and sending the compliance report to the respective auditing agency

• Handled Critical documents like Market complaint, Deviation, Change control (Logging, investigation and their closure)

• Was an active member of GMP Compliance team in solving product related issue and proper co-ordination with other departments for smooth functioning of system

• Audited different vendors for Packaging material and Finished Goods distributors

• Prepared the Internal Audit schedule and coordinated with the team for Self Inspection. Prepared the observation and compliance report for improvement in Quality System

• Prepared Batch Manufacturing Records (BMR), Batch Packing Records (BPR) and SOPs

• Prepared Annual Product Quality Review Reports

• Reviewed BMR, BPR and test reports from QC and timely release of batches for distribution

• Was responsible for preparation and updating of Site Master File

• Was responsible for preparation, execution of validation protocols and preparation of validation reports

• Ensured periodic validation and Re-Validation related to process and Equipments/Instruments whenever required

• Imparted training to sub ordinates on cGMP topics as well as on job SOPs training to comply the training schedule and Calendar

• Assisted department head in developing Systems, SOPs and documents as per GMP requirements

• Was responsible for Preparing monthly report and submitting to CQA and Management as per MIS (Management Information System)

• Ensured optimum productivity in term of work in the department

Bharat Biotech International Ltd. India

Executive, Quality assurance May 2005–Sept 2006

• Did In-process checking and sampling of Intermediate, Bulk Finished and Finished Product

• Reviewed BMR and BPR and did final release of batches for distribution

• Implemented on-line inspection system and procedures

• Executed of process validation for new products

• Prepared of daily observation report by visiting different areas and departments

• Controlled documentation issuance and retrieval including BMR, SOPs, and other controlled documents

• Was responsible for qualification and training of Visual Inspectors

• Did Periodic Monitoring of control samples and their documentation

• Did Terminal Inspection of finished goods at warehouse before final dispatches to various regulatory and domestic markets

Torrent Pharmaceuticals Ltd India

Senior Technical Assistant, Quality assurance Feb 2004-May 2005

• Did In-process checking and sampling for Intermediate, Bulk Finished and Finished Product

• Controlled the issuance and retrieval of documents including BMR, SOPs, and other controlled documents

• Did Terminal Inspection of finished goods at warehouse before final dispatches to various regulatory and domestic markets

• Actively participated in Process validation, execution of validation protocols and sampling as per plan

• Addressed client grievances related to quality issues

USV Ltd. India

Officer, Quality assurance Aug 2001-Feb 2004

• Did In-process checking and sampling for Intermediate, Bulk Finished and Finished Product

• Reviewed BMR and BPR, stage wise to facilitate timely release of batches

• Did Terminal Inspection of finished goods at warehouse before final dispatches to various regulatory and semi-regulatory countries

• Actively participated during Process validation

• Did issuance and retrieval of documents including BMR, SOPs, and other controlled documents

• Was responsible for periodic Monitoring of control samples and their documentation

Trainings attended:

• cGMP, GDP, Pharmaceutical products validation

• Workshop on CAPA held by Health Quest Foundation, India

• Schedule L1 and QMS held by ISPE, India

Audit Exposure:

WHO India, USFDA, ANVISA Brazil, MHRA UK, TGA Australia, MCC South Africa, FDA Tanzania, FDA Uganda, FDA Kenya, Customer Audits from MERCK, NOVARTIS, GSK and ROCHE

Skills:

Microsoft Excel, Word, PowerPoint, Paint, FTP, adobe, Photoshop, Internet and familiarity with SAP Enterprise Resource Planning systems.

Honors and Achievements:

• Glenmark Pharmaceuticals Ltd.:

Awarded the Extra Mile Achievement Card as a token of appreciation for proposing the idea of Retrospective Process validation and executing the same in a stipulated Target time in Aug.2010.

• Piramal Healthcare Ltd.:

1) Awarded Certificate of Appreciation for initiative taken during transfer of new Products (2008-2009)

2) Honored as ‘Executive of the month’ for the month of November 2009 and found a full-page coverage in the Quarterly published magazine ‘Kshitiz’ for Oct-Dec 2009

3) Awarded the Certificate of Appreciation for meeting Plant Target (2007-2008)

4) Awarded the Certificate of Appreciation for meeting Plant Target (2006-2007)

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