Pooja Vaghela

Development and Maintain Quality Agreements:

Collaborate with Internal and External stakeholders, such as contract manufacturers, suppliers and partners, to

develop comprehensive QTA. This includes defining Quality expectations, roles and responsibilities as well as establishing communication.

• Compliance with Regulatory Requirements: Ensure that QTA comply with applicable regulatory requirements, such as GMP, GDP and other regulations. To identify and address any deviations or Noncompliance issues.

• Quality Risk Oversight: Provide oversight and ensure to Quality Assurance Activities outlined in QTA, such as batch records reviews, change control, deviation management and Quality Investigation.

• Participate/Facilitate cross functional investigations.

• Tracking and trending of deviations and CAPAs.

• Follow-up and verification of completion of Corrective and Preventive Actions.

• Promoting Right First Time and Continuous Improvement culture by using analytical tools, introduction / updating of site systems and solutions.

• Monitoring applicable Quality Systems, compiling metrics and reports on a regular basis.

• Preparation and review of Vendor Approval documentation.

• Support / represent systems during regulatory audits, assisting and supporting cGMP audits.

• Completion of in-house GMP Inspections and Internal Audits.

• Producing and reviewing of documents (SOPs, training modules / materials) in compliance with site procedures and regulatory requirements.

To prepare Product Quality Reviews: Evaluate Product Quality,Identify Trends and Deviations Support Continuous Improvement.

• Conducted internal audits to assess adherence to regulatory requirements, company policies.

• Collaborated with cross-functional teams to identify areas for process improvement and implemented corrective actions to enhance operational efficiency.

• Prepared detailed audit reports, highlighting findings,recommendations and risk mitigation strategies for senior management and external stakeholders.

• Established and maintained strong relationships with key stakeholders, fostering a culture of transparency and accountability.

• Led external audits engagements, liaising with regulatory bodies and ensuring compliance with GMP, GLP and other relevant standards.

• Be self-motivated, flexible, organized and a good team player with the ability to prioritize own work based on departmental and site requirements.

• Created documentation templates for tracking inspection results, corrective actions taken.
• Coordinated with other departments to resolve problems related to product design or manufacturing process.
• Developed and implemented quality control systems to monitor production processes.
• Performed root cause analysis investigations on defective products using statistical techniques such as SPC.
• Evaluated vendors' capabilities by conducting periodic visits at their facilities.
• Conducted quality assurance inspections of incoming materials and products to ensure compliance with established standards.
• Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
• Identified quality problems and recommended solutions.
• Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.