Highlights:A professional with 8+ years of experience in Quality Assurance and over 9 months in Analytical development. Working as Sr. Executive Quality Assurance in middle management with Novartis Vaccines, Ankleshwar, Gujarat, India. Worked as Management staff in CQA department of Cipla Ltd. Verna Goa. (India). Worked as Sr. Executive-QA in parenteral department of cadila healthcare ltd, Ahmedabad, Gujarat (India). Worked as Executive-QA in Sterile product Division of Strides Arcolab, Bangalore, Karnataka (India). Possess insightful experience in IPQA activities, QMS system, involving software like SAP, Sentry Track wise Application. Comprehensive knowledge and experience in HPLC (manual & auto sampler), IR, FT-IR, UV-Visible spectrophotometer (single and double beam) and many analytical instruments. Excellent communication & interpersonal skills with proven abilities in resolving complex issues. Possesses a strong commitment to the workplace and to responsibilities. Good knowledge & experience over ERP related applications like SAP.

Skills:quality Assurance in drug manufacturing

Goal:To seek a challenging position in a progressive organization that gives scope to update my knowledge and skills in accordance with the latest technologies.

Certification:Crtified Lead investigator and quality assurance approver for the deviation management system.

Senior Executive Quality operation 09/2013 - current
Novartis Vaccine, Ankleshwar, Gujarat India
Industry: Pharmaceutical
Management of Quality Management Systems Review of Manufacturing, packaging and supply chain activities. Review of SOPs Support self-inspections and health authority audits Reviewing the facility / systems with respect to current regulatory guidelines
? Responsible manufacturing Quality Assurance associate for Primary manufacturing process for production of Rabies Drug Substance, packaging and supply chain activities. ? Role involves activities like review of Master formula records, manufacturing instructions, process validation documentation, review and approval of change controls & deviations. ? Single point of Contact for Batch release and distribution within Asia Pacific region – Support to regional quality team for batch release – In transit data review and review of distribution chain. ? Involved in review, roll out and implementation of best practices for quality on shop floor and batch release process. ? Trained for Deviation management process, Novartis certified Lead investigator for process related deviations. ? Support quality team for review of qualification, process validation and stability documentation. ? Support self-inspections and health authority audits--
Management staff (quality auditor) 07/2012 - 09/2013
Cipla Ltd, verna, Goa India
Industry: Pharmaceutical
Self-inspection Management of Quality Systems Review and harmonization of equipment and process validation documents across the location Review of SOPs Audit compliance Reviewing the facility / systems with respect to current regulatory guidelines
? Reviewing the Quality Documents and in process records, resolving quality related problems associated with it. ? Executing the final check and release of Batch for distribution. ? Troubleshooting all technical problems, conducting various inspections to ensure that products developed are in compliance with pre-set quality specifications. ? Updating the existing Procedure as well as reviewing & checking the technical details of Process and approving it. ? Conducting internal audits of plant and implementing current changes and implementation of value added techniques--
Senior Executive Quality operation 01/2009 - 07/2012
zydus cadila (CAdila healthcare Ltd.), Ahmedabad, Gujarat India
Industry: Pharmaceutical
? Reviewing the Quality Documents and in process records, resolving quality related problems associated with it. ? Executing the final check and release of Batch for distribution. ? Troubleshooting all technical problems, conducting various inspections to ensure that products developed are in compliance with pre-set quality specifications. ? Updating the existing Procedure as well as reviewing & checking the technical details of Process and approving it. ? Conducting internal audits of plant and implementing current changes and implementation of value added techniques
? Review of QMS documentation like Deviations, incidents, change controls. ? Evaluation and investigation of Out of specifications results & product failure. ? Investigation of system / product deviation. ? Tending of product Quality parameters. ? Co-ordination with Regulatory department for collection review primary data received from different departments towards regulatory dossier compilation. ? Final Review of BHR of parenterals, lyophilization facility, aerosol and transdermal department, and product release for distribution. ? Review and approval of BMR, BPR. ? Executing process validation in co-ordination with manufacturing and F&D. ? Export batch certification. ? Participated with the audit team of the company during the regulatory audits from, USFDA, WHO Ministry of Health-Ukrain And EU (Hungary).--
Executive quality operation 03/2007 - 12/2008
Strides arcolab, bangalore, karnataka India
Industry: pharmaceutical
involved in the shop foor activity like production of batch and inprocess quality checks.
? Preparation and retrieving of SOPs and batch records. Review of cross functional departmental documents. ? Co-ordination with Regulatory department for primary data documents, certificates, & sample required for submission collection and review primary data received from different departments. ? Preparations of Cleaning Validation matrix, protocol, execute same and creation of reports. ? Preparations of System Validation protocol execute same and creation of reports. ? Participated with the audit team of the company during the regulatory audits from MHRA, TGA, ANVISA, WHO, Ministry of Health-Ukrain. And our customer’s audits like Aspen from South Africa, Cardinal from UK and USA, Actavis from UK, Sandoz US, B-Brown UK, Teva UK and US. ? Undergone on job training for CLEANING VALIDATION by Destin A. LeBlanc from cleaning validation technologies USA. at Strides Arco Lab. Bangalore--

KLES college of pharmacy 03/2005 - 04/2007
Belgaum, Karnataka, India
Degree: Master's Degree
Major:Pharmaceutical chemistry
completed the masters degree with 72%

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