Maulik Dadhania

• Led daily operations of the QAIP department on a temporary basis, overseeing workflow, staffing assignments, and execution of in-process quality functions to ensure compliance with GMP, GLP, SOPs, and safety standards. • Reviewed and approved all major non-conformances generated within the QAIP department; led investigations, provided guidance to non-conformance investigators, and implemented CAPAs to prevent recurrence. • Reviewed, approved, and guided implementation of Change Controls and SOPs; authored, reviewed, and approved new/revised SOPs to maintain regulatory compliance. • Scheduled and assigned staff as appropriate to ensure efficient daily operations; coordinated projects/activities and generated reports in conjunction with QAIP staff and the Manager. • Ensured QAIP department was properly equipped and in good working condition; trained and qualified staff to execute their duties. • Conducted monthly one-on-one performance conversations with direct reports; delivered annual Performance Reviews and conducted Interim Performance Reviews/Discussions. • Recruited, trained, developed, and managed ongoing performance of direct reports (Coordinator, QAIP QS5/QS6/QS7 roles; 5–10 total). • Covered duties of the Manager, QAIP Manufacturing & Packaging in their absence to maintain operational continuity.

• Provide QA oversight for all Production line activities, ensuring compliance with documented procedures and standards. • Conduct sampling, inspection, and physical testing of in-process and investigational samples, reporting results in SAP and LIMS. • Perform reserved sample inspections and manage waste disposal as required. • Conduct regular inspections and audits of production and packaging areas to verify adherence to established standards. • Assess production line impacts and authorize resumption of processes following stoppages or deviations. • Review and approve sterile and non-sterile Production Batch Records based on established priorities and standards. • Manage the control, archiving, and completeness review of Production Room, Process and Equipment logbooks. • Authorize decisions for processing, reworking, or manufacturing at risk based on quality assessments. • Initiate, review, and approve Deviations, CAPAs, and Change Controls within QA and Production departments. • Perform time-sensitive viscosity testing for bulk materials. • Support the cleaning validation program by coordinating equipment sampling and releasing equipment for validation, verification, and monitoring per GMP and procedural requirements. • Assist with AQPIC-related requirements for controlled substance transactions. • Train new QA Coordinators, ensuring training records are accurate and GMP-compliant. • Analyze data and gather information for annual product reviews. • Act as a substitute for the Supervisor, performing their duties during absences.

• Author, coordinate, execute, and summarize protocols for Commissioning, Qualification, and Validation (Equipment, Facility, Sterilization, and Process), including Media Fills and Smoke Studies. • Assess proposed changes to validated production equipment and processes, providing technical evaluations and recommendations. • Prepare Sterilization Process Validation reports and other documentation for regulatory submissions (FDA, Health Canada, EU), including deficiency responses, comparability protocols, new submissions, and supplements. • Conduct temperature mapping and monitor Vaporized Hydrogen Peroxide (VHP) processes. • Operate and maintain validation equipment/instruments (e.g., Kaye Validator, HPVM, LTR, HTR, SIM, TCs, IRTD), assisting with calibration as needed. • Develop and update SOPs and Change Control Forms within areas of expertise. • Evaluate and perform requalification following significant changes to products or manufacturing processes. • Execute annual revalidation of sterile equipment (e.g., Autoclaves, SIP systems, Isolators, VHP, AHP). • Review execution data, perform statistical analysis, and prepare summary reports for validation activities. • Collaborate with suppliers to obtain necessary technical documentation and information. • Provide technical support to other departments as required, leveraging validation expertise. • Conduct peer reviews of validation documentation to ensure accuracy, completeness, and compliance with cGMP and SOPs. • Work safely and collaboratively as a team member to achieve departmental and organizational goals.