Dharti Patel

Task Assignment and Workflow Management

Progress Monitoring and Deadline Compliance

Team Member Coaching and Conflict Resolution

Stakeholder Reporting

Team Progress Tracking and Improvement Identification

Conflict Resolution (Constructive and Fair)

• Open and Closed the store, Which included Counting Cash drawers and making bank deposits
• Maintained visually appealing and effective display for the entire store
• Helped customers select product that fit their personal needs
• Offered exceptional customer service to differential and promote the company brand
• Kept the station clean and maintained neat, sanitized, orderly product displays
• Communicated merchandise needs issues to appropriate supervisors in a timely fashion
• Processed shipments and maintained organized stock shelves
• Operating Drive Thru customer service.

• Assisting Manager and Supervisor in investigating deviation’s and ensures that CAPA are identified and implemented
• Assisting FDA inspections and audits
• Review BMR, PMR and Protocol documents in each stage of manufacturing and packaging
• Assisting to ensure non-conformances are investigated for the root cause and product impact
• Investigate deviations and customer complaints
• Approving and Issuing Batch records
• Review batch documentation and disposition products
• Providing cGMP training
• Creating Controlled forms and archival of documents
• Approving and rejecting containers, closures and related materials
• Making sure that employees follow documented procedures and standards
• Discussing inspection results with QA and Production Managers
• Major and Minor Clearance, Start-ups
• Monitoring each stage of Manufacturing and Packaging
• Ensuring that all testing is performed to highest standards
• Checking production method meets relevant legislation
• Conducting quality audit, AQL, final inspections
• Looking out for defects in the product, accuracy of labels
• Performing inspection results with purchased parts
• Review raw materials and packaging component records and disposition accordingly
• Blend Uniformity and Composite Sampling
• DI, Reverse Osmosis Water Reading
• Cleaning Validation and Verification for Manufacturing and Packaging equipments
• Computer skills with knowledge of Excel, Word etc
• Any other duties assigned.

• Proficiently handling In-process quality assurance (IPQA) testing for finished products in Manufacturing and Packaging department in cGMP environment as per established procedures
• Verifying raw materials status in pharmacy and warehouse department; review, release and issuing the raw materials/documents for production use
• Experience in issuing of line clearance for Manufacturing, Inspection, and Packaging department including verification of room/equipment cleaning and swab analysis to ensure rooms are adequately clean and ready for production run
• Perform AQL for final product for the inspection; Finished Tablet/Capsule testing as a physical testing and fill the record in final testing sheet
• Collect all Samples for heavy metal, quality control, sample for micro, control sample, and sample for AQL
• Excellent at reviewing and maintaining Batch Manufacturing Records (BMRs), CoA and other related documents
• Assisting in the performance verification (PV) of production equipment including but not limited to weighing scales/balances, disintegration apparatus, friability apparatus etc
• Possess knowledge of USP/NF, cGMP, regulation and risk management requirement to allow for independent assessment of information in accordance with standard operating procedure
• Highly involved in interdepartmental activities between manufacturing, QC, and QA departments.

• Hands on experience on performing in process quality assurance testing for finished Products such as Particle size, Bulk Density, Tap density etc
• Checking of Physicochemical Properties such as pH, Viscosity, and Specific Gravity
• Experience in issuing of line clearance at every step of batch manufacturing
• Maintaining Temperature for whole process and required speed for the mixture
• Expert at review Arranged all record sheets in Batch record and reviewing Whole Batch record according to established SOPs.