Vinod Khaire

• Executed internal audits across departments to uphold quality standards.
• Developed and implemented strategic plans to achieve company objectives.
• Reviewed completed work to verify consistency, quality, and conformance.
• Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
• Assigned work and monitored performance of project personnel.
• Planned and led team meetings to review business results and communicate new and ongoing priorities.
• Resolved customer inquiries and complaints requiring management-level escalation.
• Remained calm and professional in stressful circumstances and effectively diffused tense situations.
• Analyzed business performance data and forecasted business results for upper management.
• Coordinated cross-functional teams to streamline processes and improve efficiencies.
• Implemented quality control measures to uphold company standards.
• Completed day-to-day duties accurately and efficiently.
• Managed quality control laboratory operations, ensuring compliance with cGxP regulations.
• Handled QMS processes including deviations, OOS, CAPA, and lab incidents effectively.
• Ensured batch release adhered to registration requirements and compliance mandates.
• Escalated critical events such as batch failures and technical complaints for management review.
• Reviewed study and qualification protocols alongside validation documentation efficiently.
• Collaborated with teams to gather information for timely documentation updates.
• Trained team members on compliance procedures while providing constructive feedback for improvement.

Performed CE-SDS, CEX, SEC, HPLC, and UV analyses to ensure accurate results.

• Qualified laboratory instruments and equipment in compliance with industry standards.
• Planned, monitored, and released In-process, DS, and DP data with precision.
• Reviewed online chromatographic sample sets and conducted audit trail assessments.
• Developed standard operating procedures for analytical instruments to enhance consistency.
• Coordinated cross-functional teams to streamline processes and improve efficiencies.
• Produced thorough, accurate and timely reports of project activities.
• Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
• Reviewed completed work to verify consistency, quality, and conformance.
• Worked effectively in team environments to make the workplace more productive.
• Managed QMS activities including OOS, OOT, incidents, change control, deviations, and CAPA.
• Prepared qualification protocols and reports, covering IQ, OQ, and PQ processes.
• Participated in GMP audits and client audits to uphold quality assurance standards.

• Performed routine and non-routine quality control testing of finished products, and stability testing of drug substances and drug products using various analytical tools of chromatographic and non-chromatographic techniques as per specifications.
• Calibration of instruments (like HPLC, UV-Visible spectrophotometer, pH meter, auto titrator, etc.).
• Performed container closure integrity testing, assay by HPLC, and on-time support for process forwarding sample testing.
• Participate in laboratory investigations, OOS, OOT, incidents, deviations, and the implementation of CAPA.
• Qualification protocols and reports preparation (IQ, OQ, PQ).
• Collection of analytical data and preparation of COA, ROA.
• Handled LIMS for the online recording of test results.
• Enforced compliance with regulatory standards and company policies.

• Contributed precision and accuracy to quality control department's instrumentation section.
• Operated various analytical instruments, including AAS, IR, UV, melting point apparatus, and osmometer.
• Provided timely support for diverse testing using multiple analytical instruments.
• Delivered accurate results while troubleshooting failures in accordance with QMS.
• Managed LIMS and LMS to ensure effective data tracking and regulatory compliance.
• Participated in CSV activities involving review of IQ, OQ, and PQ protocols and script testing.
• Ensured adherence to data integrity and good documentation practices in chromatographic processes.

• Conducted titrimetric analysis to ensure product quality and compliance.
• Calibrated instruments daily, including weighing balances, pH meters, and conductivity meters.
• Managed sample testing flow and tracked material release effectively.
• Executed raw material sample testing for loss on drying and gravimetric analysis.
• Performed assay and residual solvent testing using HPLC.
• Utilized atomic absorption spectrophotometer for precise measurements.