Bharathi Paramasivam Email & Phone Number

Chennai Area, India

• Leading the team of Investigation( non-conformities like deviations,OOS, OOT, failures, Market complains).• Responsible for review of change control, deviation, CAPA, incident, Reprocess in QAMS and for review of Effective Monitoring of CAPA.• Responsible for review and approval of SOPs, GTPs, specification, Protocols.• To oversee elements of Training Quality System.

Sriperumandhur

Investigation and Stability Management:• Managed investigations:LIRs and MIRs(OOS,OOT ,Incidents, Events,QARs)• Practitioner for Human Errors investigation.• M1-Practitioner:M1- investigation (DMAIC Approach).• Practiced applying Quality Risk Management (QRM)principles and identifying appropriate CAPA to mitigate recurrence.• Provided direct input or coaching support by performing peer review.• Actively conducting weekly review meetings and working closely with the Quality management groups to ensure timely closure of investigations.

Hyderabad Area, India

Key Responsibilities:• Approved technical staff(DCA-AP) responsible for product release. • Handling of OOS , OOTs , incidents, deviations and market complaints ( in QC), completing and ensuring their timely closure.• Effective utilization of Manpower in meeting compliance and timeline as per management requirement.• Prepared and executed Control limits ,trend charts for test parameters to facilitate OOT investigations.• Conducted gap analysis on test methods to meet regulatory requirements.• Supported, advised on trouble shooting matters to analytical staffs when required. • Coordinate wIth MSAT on resolving analytical issues,Review of product Dossier(QC review). Review of Annual Review of Drug Product Quality Reports. .• Involved in method validations and method transfers.• Ensure the training adherence of departmental employees as training coordinator.