Manali Vilas Pingale

Supplier Quality Management.

• Audit planning and CAPA management service: Developed a comprehensive supplier annual audit plan for ESO and NTO sites.
• Executed QARP and FURP roles in AQWA-A to audit CAPA activities for external supplier audits.
• Served as key user in AQWA-A for ESO and NTO.
• Maintained audit tracking, performed reconciliation, and prepared GMP schedules.
• Facilitated communication between site, supplier, and services under QOP to ensure business needs were met.
• Handled audit reports and managed CAPA and ECA closure in the system.
• Coordinated audit support for BP with local time considerations.
• Supporting new service transitions.

QMS Document Maintenance Coordinator:

• Supported GTx site as coordinator to ensure the new STD, SOP, WP, and FRM have been effectively implemented through proper gap analysis and training, if needed, through QE.

Quality Performance Monitoring:

• Providing details to Quality Management reports.

Product/Batch release service:

• Supporting the batch release service for the ESO RCC sites (SAP, Dragon).

• Expertise in method development and validation for OSD, liquids, creams, ointments, and injectables with HPLC/UPLC.
• Preparation and review of analytical method development protocols, validation reports, and method transfer reports.
• Skilled in the method of transferring different dosage forms from R&D to Quality or CMO with a risk-based approach.
• Ability to convert HPLC methods into UPLC methods to reduce run time and provide. Experience in cleaning method development and validation, as well as dissolution method development and validation for finished products.
• Assistance and troubleshooting support for analytical methods in Quality Labs and external sites.
• Coordination with Quality Control laboratories during investigations of lab incidents and deviation investigations.
• Handling of OOS and atypical results generated during analytical testing.
• Management, planning, and execution of stability testing as per ICH guidelines for product development until shelf life.
• To drive QIP for the improvement of selected quality systems.
• Laboratory Instrument Qualification, Calibration, Investigations, Analytical Validation, Stability Testing (Pharmaceutical), and Reports Writing.
• Perform routine GEMBA and ensure timely closure of GEMBA observations for audit readiness.
• Performed L1 and L2 audits according to the approved schedule.
• Ensured the QMS compliance with the timely closure of actions in Track wise arising from deviations, change control, and self-inspection audits.

• Analytical testing, method development, and stability analysis.
• Analytical Skills, Stability Testing (Pharmaceutical), Stability Management.
• Finished product testing.

• Analytical testing, method development, stability analysis, and SOP preparation.
• Data compilation and reporting.
• Calibrations and validations

• Calibrations of analytical instruments, SOP preparation, CAPA action implementation, finished product testing, and stability testing,
• Analytical testing as per PQS.
• Supported site for the remediation program for continuous improvement.
• Hold time study for dosage forms.
• Cleaning validations.
• Review of analytical methods and PQS.

• IPQC checks, line clearance.
• Testing and reporting for raw materials and finished products.
• SOP preparation.
• Calibrations of instruments.