Ripal Patel

My department at Atomvie involve in the discovery, development and distribution of next generation Radiopharmaceuticals. The products are customized and used daily for the detection and treatment of human diseases such as cancer

• Working experience in clinical trials and development with Radiopharmaceutical research and process development in grade A cleanrooms with given protocols and procedures
• Support formulation development for analytical testing related to stability, compatibility and pre-validation studies
• Ensure, in collaboration with the production staff, consistent production of radiopharmaceuticals according to operational expectations
• Maintaining weekly scheduling, meetings, planning work; appraising and coaching performance as well as any relevant training
• Act as point of contact for other departments and team members for matters related to the GMP Production Facility
• Working in scaling up current processes and improving for new and current formulations with research and development team
• Trained to dispense and handle radioactive substance like Iodine-131, Iodine-124, Lu-177, In-111 and Ac-225
• Experienced in Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing
• Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable International regulatory requirements relating to nuclear safety and cGMP manufacturing
• Experience in Health Canada and FDA GMP requirements for sterile pharmaceuticals
• Working knowledge and experience with Quality Systems; along with local and global regulatory guidelines (e.g
• ICH, GMP, GCP and GLP)
• Professionally trained for root cause analysis including OOS and OOT using risk-based assessment tools, quality by design tools and independently troubleshoot method related problems in GXP systems.

• Scheduled monthly production to meet the customer order and ensure smooth supply plan
• Used Minotaur ERP system for generation of work orders, production runs and inventory reports
• Issued required production records/master manufacturing documents and generated product labels
• Complete internal audit course for ISO 13485:2016/MDSAP and ISO 19011:2018(audit standards), and serves as a current internal auditor for the company
• Understanding and working knowledge of Health Canada and FDA requirements for Cosmetics and Medical Devices and regulations for importing and distribution
• Initiated and investigated deviations related to the product, procedure, equipment and operator and completed disposition of affected product and participated in design of corrective action plan and preventive action plan
• Experienced in Formulation of Rabbit plasma Coagulase and involved in antibody purification techniques
• Perform validation for new as well as for existing equipment with production supervisor
• Trained in root cause analysis including OOS and OOT using risk-based assessment tools, quality by design tools and independently troubleshoot method related problems in GXP systems
• Reviewed and updated manufacturing instructions, standard operating procedure for equipment, processing units, for necessary changes and updates reflecting current usage
• Worked in conjunction with the Production Supervisor and QC Supervisor to advise Customer Service of regular and custom orders product released for final packaging based on customer order
• Act as a bridge between production technician and production supervisor and timely delivery of trainings to technicians regarding updated SOPs, Manufacturing Instructions, and Corrective Actions following deviation / non-conformance investigation.

• Performed all duties in accordance with the applicable SOPs and company policies following Good documentation practices for the production of oral solid dosage forms
• Safely operated all equipment and machinery to process batches within specifications to meet department batch execution targets
• Performed SAP entries in a timely manner to execute a batch production
• Maintained equipment, tools and inventory of consumables and ordered needed items in a timely manner to ensure smooth manufacturing process
• Dismantled, cleaned, sanitized and assembled manufacturing equipment according to established SOPs and meet department changeover targets
• Mentored new employees in the department as per departmental requirement for equipment setup, operation, dismantling and cleaning, proper tools selection, task prioritization, pharmaceutical waste classification and documentation.

• Develop and execute microbiology testing methods, interpret data, and provide insights that drive decision-making
• Accurately follow SOP’s and improve SOP’s as necessary
• Prepare sample for analysis by recording, weighing and blending
• Perform physical testing on QC samples
• Testing includes: Microbial Enumeration Tests, Membrane filtration, TOC analysis, Coliform testing
• Experience operating an autoclave, incubator, laminar flow hoods
• Excellent plating and streaking skills
• Pipette sample solution into tubes or plates according to the analysis process being performed
• Perform method validation/ suitability for microbiological tests, specifically bioburden and endotoxin testing.