KALITHAS SEENIVASAN

Dynamic manager and analytical problem-solver with a proven track record in team building, leadership, and motivation, complemented by exceptional customer relations and relationship-building skills. Expertise in independent decision-making and sound judgment drives positive outcomes for organizational success. Committed to leveraging training, monitoring, and morale-boosting strategies to enhance employee engagement and elevate overall performance. Passionate about fostering a collaborative work environment that empowers teams to excel.

• Six sigma and the organisations (Advanced) by Coursera
• Project Management principles, performance domains, tailoring by Coursera
• Project management models, methods, and artifacts by Coursera
• Project Management Knowledge Areas by Coursera
• GMP training

• Handled OOS (Out of Specification), OOT (Out of Trend), and laboratory investigations with complete documentation and compliance to regulatory standards.
• Prepared and provided CAPA reports and supporting documentation for customer and regulatory audits.
• Reviewed and updated SOPs, IOPs, and QC specifications, ensuring compliance and timely implementation.
• Reviewed and monitored method validation protocols, analytical reports, and validation/cleaning validation reports.
• Oversaw quality systems to ensure adherence to cGMP requirements for sampling plans, design control, and documentation.
• Supervised analytical work and documentation in alignment with global regulatory guidelines.
• Coordinated with cross-functional teams for internal quality audits (self-inspections) and ensured timely closure of identified gaps.
• Addressed regulatory authority queries with proper documentation and scientific justifications.
• Conducted gap analysis for SOPs, IOPs, and QC specifications to ensure completeness and compliance.
• Reviewed GMP documentation and verified audit trail reports for instruments and raw data integrity.

• Performed analysis of Raw Materials (RM) as per documented procedures.
• Conducted analysis of In-Process (IP) samples to support manufacturing operations.
• Carried out analysis of Finished Products (FP) and Stability samples in compliance with cGMP requirements.
• Performed calibration and routine maintenance of analytical instruments.

• Managed Quality Control (QC) department operations and provided support to Production.
• Oversaw raw material, in-process control (IPC), and finished product sample analysis to ensure compliance with quality standards.
• Directed stability studies for Active Pharmaceutical Ingredients (APIs), enzyme tablets and biopharmaceutical products.
• Managed instrument qualification and calibration activities to maintain accuracy and regulatory compliance.
• Led and completed analytical method validation activities in accordance with industry guidelines.
• Coordinated with cross-functional teams (CFT) to support new product launches and ensured timely completion of analyses.
• Supervised team members and oversaw dispatch activities.
• Supported Production in process validation and cleaning validation by planning and executing timely analyses.

• Investigating incidents, reviewing specifications, managing team and analysis
• Investigating the incident, OOS, OOT documents
• Reviewing the specification, SOP
• Trouble shooting of instruments
• Managing team
• Strong in analysis
• Discussing with the Cross functional team to resolve the product problem

• Team member of the Overall Equipment Effectiveness (OEE) with CF team
• Team member in the internal audit Certified as Internal auditor