PINKAL PATEL

Develop and implement quality assurance (QA) systems to ensure compliance with food safety regulations (HACCP, GMP, ISO).
Conduct internal and external audits to verify adherence to food safety standards and prepare for certification inspections.
Oversee documentation of quality records, product specifications, and compliance reports to ensure traceability and accountability.
Lead supplier quality management programs, including raw material audits and supplier qualification processes.
Implement corrective actions for non-conformances, driving continual improvement in production and safety standards.
Manage product development, including recipe formulation, ingredient testing, and sensory evaluation to enhance product quality.
Optimize production processes, improving efficiency, consistency, and cost-effectiveness while maintaining high product standards.
Perform shelf-life and stability testing to ensure product safety, quality, and compliance with regulations.
Ensure accurate and compliant labeling, including nutritional facts and allergen information, in line with food safety standards.
Collaborate cross-functionally with R&D, production, and regulatory teams to drive innovation, product improvement, and quality assurance strategies.

• Regulatory and Quality assurance procedures.
• For the EU market, extensive knowledge of the EMA is required for batch release, QP paperwork, RP evaluations, commercial regulatory requirements, post-approval activities, and dossier preparation and submission through eCTD.
• In the USFDA market, worked on commercial release, including labelling and post-approval work. In addition, I assisted with critical revision activities related to non-compliances and pharmacovigilance updates.
• For the TGA Market, Files were submitted for clearance and marketing for commercial distribution. TGO92, ARGPM, risk management plan, and e-submission expertise are required. Approximately eight pharmaceutical items were successfully submitted to the TGA.
• Worked on post-approval and safety variation operations for commercial release for the health Canada market.
• Managed over 19 people in team and over 300 critical Email communication per day with medical regulatory bodies.
• review regulatory documents like validation of specifications, stability and quality control for batch release.
• Depth knowledge of EMS, US FDA, TGA, Health Canada for medication label practice in accordance with regulatory body.
• Operate and troubleshoot various pharmaceutical instruments and prepared SOP for operational in line with regulatory guideline.
• Team management and work allocation to meet market objectives.
• Change control procedure and authorized change implementation within timeline for compliance/control purposes to reduce unplanned incidents.
• In QA software, increase CAPA, Deviation, DRF, or CRF to support regulatory requirements or minimize market compliance, and submit to authorities.
• Thorough understanding of agency notification for discrepancy or noncompliance, batch recall or exception to support business model, regulatory documentation submission, National and International Guidelines, marketing authorization, batch release process, SAP operation, pre-approval and post-approval activities.
• Conducted weekly staff meetings to motivate staff members, address concerns and questions, plan improvements and evaluate progress toward goals
  Created employee schedules to align coverage with forecasted demands

• Samples from several departments are being analyzed.
• Dissolutions, HPLC, method validation, method development, and stability are all areas of expertise.
• Data interpretation and strict adherence to guidelines.
• Preparation of product specifications for method development.
• Using a variety of analytical techniques such as gas chromatography (GC), HPLC (Waters, Shimadzu), UV (Perkin Elmer), FTIR (Perkin Elmer), dissolution with auto sampler (Lab India, Distek, and Electro Lab), Auto Titrator (Metro ohm), KF Titrator (Metro ohm), and other instruments and software on a regular basis in the analytical development department.
• API verification and method and certificate preparation for regulatory submission.
• Examine all documents presented to the authorities for approval.
• Conducted risk assessments for research where applicable

• Developing new techniques for the analysis of drug products
• Conduct Dissolution, stability and release QC study for the exhibit batch.
• Working collaboratively in cross-functional teams.
• Validating methods and equipment and developing new analytical methods.
• Knowledge of IVIVC (In vivo - In vitro co relationship).
• Work with GLP compliances and knowledge of QbD.
• Calibration and Trouble shooting in routine instrument in Analytical work.
• Method Development for Cleaning, Assay, CU, BU and Related compound Validation.
• Analysis of Raw material and API verification.
• Identified issues, analyzed information and provided solutions to problems.

• Bio-Analytical methods (LLE.SPE and PPT) as Analyst.
• Wet analysis Processing with plasma or serum, blood and urine-based BA/BE studies.
• Instrumentation of LC/ MS/ MS, HPLC and ICP as Operator.
• Documentation of project by following GCLP, GLP, GDP, WHO and FDA guidelines.
• Records of Calibration and Maintenance of Various Experimental instrument like PH Meter.
• Operator of Evaporator, Centrifuge, Vortexes, weigh Balance, pipette, Wake-in-freezer, Ultrahigh Temperature, Freezers etc.
• Documentation of maintenance of Reference Standers and Clinical Sample handling.
• Preparation of COA for new drugs and SOP.

• Assist in preparation and dispensing of medications.
• Re-Package and label products and extemporaneous doses
• Package and label medications and pharmaceutical products
• Consulted with insurance company representatives to complete claims processing, resolve concerns and reconcile payments
• Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists
• Maintained proper drug storage procedures, registries and records for controlled drugs
• Entered and processed patients' prescriptions into internal system
• Communicated with prescribers to verify medication dosages, refill authorizations and patient information
• Resolved non-routine issues like third-party billing, computer system and customer service issues
• Counseled customers on medications, appropriate dosage and potential side effects
• Restocked pharmacy shelves with current merchandise to drive consistent peripheral sales
• Counted, measured and compounded medications following standard procedures
• Located and measured medications according to prescription information, making modifications as instructed by pharmacists and providers