SAIKISHORE PINAKANA

A result-oriented professional with excellence in implementing quality mechanisms to deliver Quality output PROFILE SUMMARY Competent professional with over 15 years of experience in Quality Control in the Pharmaceutical industry. Proficient to enhance operational effectiveness and meet operational goals within the Quality and Time. Skilled at carrying out Finished product & Process validation analysis, Analytical method transfers, Analytical method validations, Analytical method verifications & Cleaning method verifications for various formulated products like Tablets, Capsules and Sachets. Comprehensive knowledge on QMS, LIMS (Caliber) and Empower software. To provide support to Regulatory and Quality Assurance for data required during submission (like Dissolution profile compilation/CDP with RLD). Trouble shooting to the analytical issues. Handling of OOS, Process non-conformances (Incidents), OTHER related issues of QC. Handling of Audit compliance in Tier-I, Tier-II and Tier –III audits. Achievement: Played LEAD USER role during the Qualifications of instruments and preparation of SOPs in QC Laboratory while setup the Lab. Played a key role in Regulatory audits like USFDA, Malta, Anvisa-Brazil, Belarus Regulatory, National Drug authority-Uganda and customer audits and acted as a team member for successful completion of audits.