Kunjan Shah Email & Phone Number

Charlotte, Nc, Us

Charlotte, Nc, Us

Mumbai, Maharashtra, In

Mumbai, Maharashtra, In

• Promoted to a Leadership position in recognition of strong work ethic and exceptional performance.• Function as a subject matter expert for Media Filling and Aseptic Practice.• Plan, & Communicate clear updates, goals, and directions to support daily & weekly schedules.• Ensuring a safe working environment by following safety rules and developing a safety culture. • Ensure manufacturing activities are performed in compliance with GDP, GMP, & Regulatory Standards.• Communicate departmental & team performance updates to the Site Management.• Motivate & support team members to achieve organizational goals.• Collaborate cross-functionally with Quality, Supply Chain, EH&S, Maintenance, and Facility.• Facilitate Training to ensure that the team can perform operations Correctly, Safely & Compliantly.• Support in Troubleshooting by providing expert opinions related to Materials, Processes & Equipment.• Regularly Audit the manufacturing area to ensure it is always Inspection Ready.• Review Process, & Equipment-related Technical Documents to identify the Scope of Improvements. • Review Batch Records & other Related Documents to ensure their completeness. • Report Incidence & Deviation to the competent team for necessary actions. • Support in finalizing Investigations, Identifying Root Cause & implementing CAPA.• Evaluate procedural Change Control requests to ensure compliance with applicable standards.• Conduct timely performance reviews for all team members.

Mumbai, Maharashtra, In

• Supervised Operation Activities in absence of the Supervisor. • Lead the Production personnel to achieve assigned goals in compliance with BPR, SOP, GMP & GDP.• Communicated shift priorities & schedules to shift personnel during daily team meetings.• Performed seamless transfer of information to incoming shift and to the Area Management.• Supported technician in Aseptic Preparation & Operation of Compounding, Holding & Filling Equipment.• Responsible for the safe operation of equipment in the Production Area.• Lead Troubleshooting efforts to Resolve, Equipment, Process, and Material-related problems.• Motivated & Empowered team members with skills to improve their confidence and product knowledge.• Reviewed activity records during and at the end of the process to ensure their completeness.• Assisted Technical writer in the investigation to identify the Root Cause and Implementation of CAPA.• Revised BPRs, SOPs, Forms, and Training materials as a part of Continuous Process Improvement.• Collaborated with Process Engineer in Developing new processes & Improving existing processes.• Created matrix for Requalification, Calibration, & Preventive Maintenance of Equipment & Instrument. • Performed Gap Assessment on GMP documents like URS, DQ, FAT, SAT, IQ, OQ, PQ, etc.• Authored, Reviewed & Executed Protocols & Reports for Validation and Study Activities.• Successfully conducted the Projects from Commissioning to Qualification of equipment.• Regularly perform GAMBA walk with Quality Assurance to keep area Inspection ready.

Mumbai, Maharashtra, In

• Acquired Technical Expertise in Equipment & Processes by understanding Process Flow, Critical Process Parameters, and Master Formula Instructions. • Safely & Accurately Operated Equipment like Blow-Fill-Seal (BFS), Pre-Filled Syringe, Vial (washing, Sterilization Tunnel & Filling) machine, (Compounding & Holding) skids, Filter Integrity Tester, (Steam & Dry Heat) Sterilizer, in compliance with GMP, BPR, & SOPs. • Used Aseptic Techniques for Component Preparation, Assembling, Operations, and Sampling Process.• Performed Real-Time Documentation for the process in compliance with GDP.• Assisted Maintenance Engineers in the Troubleshooting of Equipment-Related Problems.• Assisted Process Engineers in Identifying and Improving Processes-Related Problems.• Assisted Validation Technicians in executing IQ, OQ, PQ & Requalification of Equipment.

Woonsocket, Rhode Island, Us

• Calculated dosage, prepared labels, and filled prescriptions with absolute accuracy.• Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.• Discussed with insurance company representatives to complete claims processing, resolve concerns and reconcile payments.• Resolved non-routine issues like third-party billing, computer system, and customer service issues.• Processed incoming drug orders by checking deliveries against paperwork and updating the computer system.• Worked alongside the licensed pharmacist to provide excellent customer service.

Mumbai , Maharashtra, In

• Acquired Technical Expertise in Equipment & Processes by understanding Process Flow, Critical Process Parameters, and Master Formula Instructions. • Safely & Accurately Operated Equipment like Blow-Fill-Seal (BFS), Pre-Filled Syringe, Vial (washing, Sterilization Tunnel & Filling) machine, (Compounding & Holding) skids, Filter Integrity Tester, (Steam & Dry Heat) Sterilizer, in compliance with GMP, BPR, & SOPs. • Used Aseptic Techniques for Component Preparation, Assembling, Operations, and Sampling Process.• Performed Real-Time Documentation for the process in compliance with GDP.• Assisted Maintenance Engineers in the Troubleshooting of Equipment-Related Problems.• Assisted Process Engineers in Identifying and Improving Processes-Related Problems.• Assisted Validation Technicians in executing IQ, OQ, PQ & Requalification of Equipment.

Mumbai , Maharashtra, In

• Ensured a safe working environment while applying fast-paced operations schedules.• Coordinated with the cross-functional team for the smooth running of production.• Revised SOPs, Batch Records, Forms, and Checklists, as a part of Continuous Process Improvement.• Participated in FAT, SAT, IQ, OQ, and PQ, for equipment in collaboration with engineering and quality.• Applied safe fast-paced operations schedules, resulting in 5 million+ unit output within a month.• Reduced GDP errors by more than 80% just by conducting regular GDP training.• Reduced downtime by ~4 hours/line/day, which resulted in increased productivity.• Achieved 20% growth in Packaging output by redesigning packaging activity.• Updated SOPs, Batch Records, Forms, and Checklists, as a part of Continuous Process Improvement.• Assigned Additional Responsibility for Production Planning & Inventory Control.

• Managed day-to-day business operations.• Helped Students in searching universities for higher education. followed by admission, Visa, and Accommodation procedures in countries like the USA, UK, Australia, New Zealand, etc.

Mumbai, Maharastra, In

• Supervised & Performed activities of Equipment preparation (CIP, PHT & SIP) Compounding (Suspension, Solution, lyophilized product), Aseptic Activities of Filtration & Filling (Vial, Glass Ampoules, PFS, Cartridge) for Engineering, Scale-Up, Exhibit, Process Validation & Commercial Batches & Media-fill Validation.• Followed applicable SOPs & cGMP and other regulatory standards to perform assigned duties and tasks, including clear and accurate documentation activities.• Conducted Regular refresher training, which reduces the recurrence of common mistakes by 95%.

• Oversaw production of Sterile and non-Sterile semisolid dosage form. Along with Injectables, oral & topical dosage form on ad-hoc bases.

• Learned all aspects of Pharmaceutical Operations i.e., Dispensing, Compounding, Filtration, Filling, Visual Inspection, Labeling & Packaging along with Manpower Management

Bachelor Of Pharmacy - Bpharm, Pharmacy

Diploma In Pharmacy