Dhara Vora , M.Pharm Email & Phone Number

Mississauga, Ontario, Canada

Scarborough, Ontario, Canada

• Responsible for disposition of imported products in the market by assessing documentation not limited to batch records, certificate of manufacture, certificate of analysis, unique ID, temperature data of imported.
• Spearheaded projects targeted at integrating Legacy Actavis quality systems with current third-party Teva quality systems to reduce operating costs.
• Collaborated with various stakeholders to maintain quality system activities such as batch release, executed batch reviews, annual confirmatory testing, stability/compendia/ APQR reviews, CAPA & deviation management.
• Promptly supported Health Canada requests, assist in investigation or recall situations.
• Ensure on-time product launches in Canadian market by evaluating launch documentation not limited to raw material specification, finished product specification, stability data, product pack artwork, validation data, etc.
• Create/revise, maintain SOPs for various clients following regulatory requirements and at the same time considering individual client’s policies and procedures.

Mumbai, Maharashtra, India

• Site lead for ensuring QA policies, systems and procedures are adhered to, assuring compliance with domestic and international GxP regulations.
• Proven expertise in writing and formalizing affiliate level SOPs.
• “Quality Responsible” personnel responsible for release and compliant distribution of imported biotechnological product shipments within very tight timelines.
• “QA SAP Lead” with expertise in MM and QM Module designed i.e. SAP P30 and SAP P57 for affiliate.
• “Affiliate Complaint Manager” responsible for handling product complaints and suspected counterfeit cases at market level using Trackwise tool.
• Extensive experience in monitoring, controlling & approving the quality agreements; analyze discrepancies and provide appropriate Corrective and Preventive Actions (CAPA), change control, product returns, risk.

Mumbai Area, India

• I worked on a Contract position in Roche India Affiliate for the following responsibilities:
• Preparation and time-to-time revision of local SOPs as per the PQS timelines.
• Oversight on redressing Activities.
• Responsible to conduct trainings for Warehouse and carrying and Forwarding Agents on Quality System.
• Assist in preparation of upcoming Audit requirements.

Mumbai Area, India

• Acquaintance with cGMP requirements pertaining to QA, Analytical testing, Warehouse and manufacturing of IND batches.
• Preparation of new and renewal of existing test licenses and import licenses for API & formulations.
• Preparation and review of existing GMP documents like SOP’s and raw data related to the calibration annexure, protocols, reports, batch manufacturing records, method / process transfer data.
• Issue and control of GMP related formats like but not limited to change control, deviations- Planned/Unplanned, out of specification investigation, training, document review forms, logbooks, general records and.

Mumbai

• Research work on “Development and Validation of Analytical Method for Assay of Anthelminthic drug in Pharmaceutical Dosage form”

Master'S Degree, Quality Assurance [Wes Verified - Equivalent To Masters Degree In Canada]

Bachelor’S Degree [Wes Verified - Equivalent To Bachelors Degree In Canada], Pharmaceutical Sciences