Hemanth Hemanth

• Reviewed production activities, including forms and batch records, for compliance with procedure requirements and product specifications.
• Oversaw quality monitoring and testing activities, including environmental monitoring and product surveillance.
• Conducted review and release of raw materials and finished goods, ensuring compliance with quality standards and regulatory requirements.
• Evaluated compliance of inspection reports, test records, and Device History Records with procedures.
• Supported CAPA investigations and managed corrective and preventive actions.
• Initiated Nonconforming Material reports and supported nonconformance investigations.
• Assisted in audits and inspections by customers and regulatory agencies; compiled corrective and preventative action responses.
• Played a key role in the archival project of Batch Manufacturing Records (BMR) and Device History Records (DHR), ensuring proper documentation and record maintenance.
• Performed additional duties as assigned.

· Conducted regulatory research and literature reviews to ensure compliance with medical device regulatory requirements for the US FDA.

· Developed regulatory strategy for the US market by executing higher-level, chronologically ordered processes and procedures.

· Developed a clinical study design and a risk/hazard analysis plan for the expanded formal human-use trial to determine device significance.

· Provided input and feedback on various regulatory activities, such as labeling and other promotional materials.

· Coordinated with cross-functional teams to ensure the timely completion of regulatory activities.

· Interpreted regulations, guidelines, and compliance requirements, effectively communicating them to team members and departments within the organization.

· Collaborated closely with the RA management team to execute regulatory strategies and ensure timely submissions to Health Authorities.

· Tracked and expedited post-approval change controls and filing status by working with regional regulatory teams and cross-functional teams at the manufacturing facility.

· Liaised with internal and external stakeholders to gather quality documents for regulatory submissions related to ANDAs.

· Prepared annual reports, amendments, supplements, change controls, CBE-0, CBE-30, PAS, and SPLs.

· Reviewed and approved verification & validation results as per standard regulations and performed In-process quality assurance Analysis.

· Managed bona fide Master Hard copy and PDF soft copy and issued batch records using the ERP program. Reviewed, approved & maintained batch records of manufacturing & packaging.

· Maintained Training Records, SOPs and archived additional QA documentation using pharmaREADY TRMS.

· Handle various Change Control requests, deviations, Corrective and Preventive Action (CAPA) from various departments.

· Worked cross-functionally to ensure all SOP, Specifications, and protocols are effective and up to date.