SOWMYASHREE C R

• Supported the Quality team by developing and executing CSV validation protocols, impact assessments and risk management documentation to comply with regulatory standards (GXP, 21 CFR Part 11, EU Annexure 11).
• To ensure that digital systems comply with regulatory standards.
• Faced compliance audits by major regulatory bodies: US FDA, MHRA, ANVISA, TGA, JFDA, KFDA, EMEA, WHO, CDSCO and customer audits.
• Handling of deviation management, change control management, and CAPA management in EQMS track-wise software.
• Providing compliance with appropriate CAPA for audit findings.
• Approached customers and engaged in conversation through use of effective interpersonal and people skills.
• Conducted testing of software and systems (DMS, LMS, FMS, Allyone, Pharmameditech, LIMS, SAP-MM, QM, WM modules, EQMS Trackwise, and lab solution) to ensure quality and reliability.
• Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
• Worked with cross-functional teams to achieve goals.

• Handled the Greenfield project to implement Labvantage LIMS in the QC team, in coordination with the TCS team.
• Supported the QC team by developing and executing CSV protocols, impact assessments, and risk assessments.
• PLC Validations.
• Worked effectively in team environments to make the workplace more productive.
• Managed inventory and supplies to ensure materials were available when needed.
• Provided support and guidance to colleagues to maintain a collaborative work environment.
• Completed day-to-day duties accurately and efficiently.
• Collaborated closely with team members to achieve project objectives and meet deadlines.
• Conducted testing of software and systems to ensure quality and reliability.

• Responsible for the supervision of the team members within the QC Microbiology laboratory. Includes scheduling of work assignments based on department priorities, reviewing analytical data and documents generated by team members, coaching, and managing the development and performance evaluation of direct reports to align with business functions. Reporting to the QC Manager for department top priorities, I managed a maximum team size of 10 employees and monitored projects to ensure progress.
• Conduct third-party audits, and manage the remediation of third-party audit findings and management responses.
• Responsible for providing the Quality Manager and department management team with audit results, and leading in closing out corrective and preventive actions.
• To review and approve specific qualification and validation documentation (IQ, OQ, PQ).
• Faced major regulatory and customer audits.

Handling of deviations, change control, and CAPA in EQMS track-wise.

Handling of lab incidents.

Handling of OOS and OOT in the Microbiology Laboratory.

Preparation, review, approval of SOP, SWI, MOA, specifications, qualification, and validation documents.

Qualification of all critical and non-critical equipment in Microbiology.