Shwetha Divakar Email & Phone Number

Philadelphia, Pennsylvania

• Author, execute and perform sampling for Process Validation, IOQ, Packaging Qualification and Cleaning Validation protocols.• Author new and update existing equipment and quality SOPs.• Manage metrology of calibrated equipment.• Working with the Validation Manager, collect samples and oversee all testing data from Process/Packaging/Cleaning Validation to ensure data is accurate and within acceptance criteria.• Provide statistical analysis of data as directed by the Validation Manager.• At the direction of the Validation Manager, oversee laboratory studies conducted in support of validation.• Assist in summarizing studies for validation reports in compliance with the cGMP standards. • Assist the Validation Department in completing all validation documentation in a timely and compliant manner.• Assist in any validation investigation and close-out exception reports and non-conformances, associated with the validation studies.• Assist in the investigation and trouble-shooting technical issues.• Perform environmental monitoring for the pharmaceutical warehouse and manufacturing area which includes air monitoring and settle plate method for microbial limit test analysis

Greater Philadelphia Area

• Performs QA in process check and complete line clearance between changeovers of two different products.• Checks printed and non-printed components, match Item and Lot number with work order.• After batch completion, perform reconciliation. • Reviews logbooks of scale, equipments as well as room logbooks.• Reviews of executed batch records and release of finished products using software• Provides direct Quality support to a production area as part of a Quality Integrated Production Team.• Ensures product / process quality and performs activities to facilitate the release of product to the marketplace.• Performs process document / log book audits for accuracy and completeness and works closely with the assigned manufacturing in a team environment to ensure timely review and documentation is done right first time.• Coordinates with Production to discuss, resolve, and eliminate documentation observations• Collaborates with production team in the identification and implementation of continuous improvement initiatives and action plans.• Prioritizes review of process documents / log books in order to maximize cycle-time efficiency.

Bachelor’S Degree

Education record

Education record