SUMMARY:

• Experience in generating and revising SOPs pertaining to quality and several other departments.
• Strong working experience in reviewing batch documentation for both packaging and manufacturing.
• Proficient with 21CFR 210 and 211 and 21CFR (Good Manufacturing Practices) and 21CFR11 (Electronic records and reports).
• Experience in handling of deviations, conducting investigations and CAPAs and conducting root cause analysis.
• Experienced in conducting line inspections, line clearances and in-process inspections during manufacturing and packaging.
• Proficient with good documentation practices and pharmaceutical industrial regulations.
• Conducted training programs and internal audits.
• Proficient in dealing with Customer Complaints.
• Experience in handling customer audits and vendor audits and assisted in a FDA audit.
• Excellent communication and refined verbal and written skills.
• Hands on experience using Microsoft office and LIMS.
• Strong technical skills along with management and leadership qualities.

EDUCATION:

• Master of Science, Pharmaceutical Chemistry
• Bachelor of Pharmacy

PROFESSIONAL EXPERIENCE:

Confidential- Sayreville, NJMar 2012 - Oct 2012
Quality Specialist

• Generate and Revise Standard Operating Procedures (SOPs) pertaining to Quality and all other departments.
• Generate equipment qualification protocols (IQ/OQ and PQ).
• Develop master documents like Batch Records, Cleaning validation and Method validation protocols.
• Review executed batch documentation for accuracy, completeness and adherence with respective SOPs.
• Conduct Annual Product Review (APR)
• Issue and log new change controls and ensure they are complete and closed out.
• Handle deviations and investigations. Conduct root cause analysis and follow up with a CAPA.
• Monitor day to day packaging operations and work with the operations Manager to resolve any issues found.
• Monitor final releases and shipments of the finished product.
• Conduct vendor audits as necessary and create summary reports for the same.
• Maintain files and binders for all original documents under strict control.
• Maintain and timely update trackers for all the documentation.
• Conduct inspections and internal audits of the facility.

Confidential-Cranbury, NJ July 2011 - Jan 2012
Quality Assurance Specialist (GLP)

• Assisting in the development of templates for selected quality metrics GLP as needed (e.g. CAPA reports, monthly QA-metrics reports, etc.)
• Receive and investigate product complaints and initiate Investigation and CAPA reports for the same
• Maintaining department tracking logs (e.g. Quality Metrics, Audits, etc.).
• Organization and maintenance of assigned QA-GMP department documentation (e.g. Internal and vendor-based Change Controls, Non-Conformance Reports, Deviations, Audit Documentation, SOPs and supporting CMC files).
• Reviewed executed documents (productionrecords,packaging records, process validation protocol,cleaning validation protocol,production investigationsand production SOPs).
• Assisting in the development of graphs and charts of all Quality metrics for presentation to senior management
• Execute any other assignments or projects as directed by the Quality Director.
• Issue of tracking numbers as applicable and filing of in-process and finished reports.
• Assist with organizing and cataloging the physical training files according to QA plan.
• Supervised a team of a QA Intern and QA Associate.
• Assisting with the preparation, updating and tracking of audit/inspection reports/CAPA Plans as directed.
• Working knowledge of quality assurance codes (GMP, GLP, CFR, and ICH) and standards.

Confidential - Lawrenceville, NJ Jun 2009 - Jun 2011
Quality Assurance Associate

• Preparation and issue of batch records, both Manufacturing (MBR) and Packaging (PBR).
• Review of Manufacturing Batch Records for accuracy, completeness and compliance with effective SOPs.
• Review of batch production records with respect to stage wise yield reconciliation, in-process checks, sampling details, line clearance and analytical reports.
• Maintain files and binders pertaining to all QA related documentation like change controls, batch records, deviations and Investigations.
• Create and Maintain trackers, for tracking the completeness of all the documents.
• Prepared Annual Product Review (APR) of various products.
• Initiate Change controls, deviations and maintain an e-document system for the same.
• Conducting training programs on Current good manufacturing practices for other QA personnel.
• Report Non-conformances, conduct the root cause analysis and document any corrective and preventive actions (CAPA) taken.
• Assign numbering for deviations and change controls. Assign unique batch numbers for each product.
• Review of QC data (Analytical reports and COA's) against the established specs.
• Issue of batch records to Manufacturing and packaging departments.
• Sampling of in-coming raw materials, in-process and finished products.
• Monitor releases and shipments of finished products.
• Timely conduct internal QA Inspections by walking in to all other departments.
• Manage change controls and deviations. Ensure their completeness and document the reports.
• Verification of data and report any deviations from approved procedures, and initiate respective deviation reports on a timely basis.
• Preparation and Revision of SOP's.
• Knowledge of c GMP (21 CFR 211 and 21 CFR 210), GLP and ICH guidelines.
• Handling of stability samples (Long term and Accelerated).