DIPTI PATEL

Core Responsibilities.

• Act as the primary contact for client quality-related topics, managing a portfolio of clients.
• Oversee quality plans and performance to support product transfers between pharmaceutical development services (PDS), external sites, and commercial operations.
• Prepare and present quality presentations for client meetings, ensuring clear communication of compliance strategies.
• Approve and oversee quality-related deviations, out-of-specifications (OOS), out-of-trends (OOT), validation protocols, change controls, and technical transfers.

Leadership and Risk Management

• Facilitate Quality Huddles and represent quality in RAPIDs (critical decision-making forums).
• Lead or participate in risk analysis, identifying potential quality and compliance risks.
• Recommend and implement quality improvements based on trends from quality systems and audits.
• Drive process improvement activities such as Mini Transformations and Kaizens, leading quality initiatives that enhance operational efficiency.

Team and Decision-Making Responsibilities

• Work with management to resolve project issues and resource constraints within the team.
• Support strategic decision-making on projects and future process directions.
• Manage team interactions, ensuring efficient collaboration and problem resolution.
• Participate in departmental huddles as needed.

Compliance, Audits, and Client Relations

• Support Pre-Approval Inspections (PAI) and client audits, ensuring compliance readiness.
• Assist in negotiating quality agreements with clients when necessary.
• Coordinate internal functional resources to resolve significant quality issues, protecting product quality and patient safety.

Staff Management and Administrative Duties

• Select, develop, and evaluate staff to ensure the efficient operation of the quality function.
• Advise staff on administrative policies and procedures, ensuring alignment with quality standards.

• Led investigations into compliance issues across manufacturing, packaging, and quality sectors.
• Conducted thorough customer complaint investigations for timely resolutions.
• Evaluated laboratory investigations on product failures and completed Phase III analyses.
• Performed risk assessments on quality issues, recommending corrective actions.
• Reviewed GMP documentation to identify procedural gaps and improvement opportunities.
• Assisted in supplier investigations addressing raw material and production challenges.
• Managed Supplier Corrective Action Reports (SCARs) to ensure quality compliance.
• Developed and updated standard operating procedures (SOPs) for continuous improvement.
• Prepared technical presentations for review by internal staff members or external stakeholders.

• Perform disposition of drug products and release/reject of various product stages.
• Conduct audit trail reviews and support master production documentation approvals.
• Review validation protocols, stability studies, and other GMP documents.

• Participate in Data Integrity projects and review technical reports.
• Approve test results and ensure compliance with specifications and regulations.
• Write and update SOPs and manage change control and deviation reports.

• Supervise staff workload, productivity, and quality.
• Provide technical knowledge and support for audits.
• Lead continuous improvement projects and staff performance evaluations.

• Supervise staff workload, productivity, and quality.
• Provide technical knowledge and support for audits.
• Lead continuous improvement projects and staff performance evaluations.

• Assist in product development projects and maintain laboratory equipment.
• Document experiments and ensure safety procedure adherence.

• Prepare and analyze samples using laboratory instruments.
• Perform microbiological analysis and ensure compliance with GMP standards.
• Conduct daily calibration of laboratory instruments.