M. Sakthivel

Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

• Perform biannual trending of Change controls, deviations, OOS, OOT and Human error investigations and reporting.
• Stability Protocol Review and drafting of stability protocols, Double check of stability protocols.
• Responsible for review and approval of analytical reports and corresponding documents to release the batches through SAP and maintenance of analytical trend, verification of In-process and Finished products.
• Responsible for review of process performance qualification and cleaning validation protocol and reports.
• Responsible for addressing of Incidents, OOT and OOS including investigation, Corrective actions and preventive action follow up and closure.
• Review and approval of Analytical technical documents of the in-house developed analytical methods, standard testing procedures and specifications for routine use by QC personnel as well as Managing post authorization activities: revisions, change control for approved methods, validation protocols & reports, etc.
• Reducing Lead Time, Improvement Projects, Kaizens undertakings.
• Responsible for gap identification on SOP and ensuring compliance w.r.to procedure vs practices.
• Responsible for review and approval of Product Quality Review Reports & Continuous Process.
• Responsible for review of Method transfer and internal calibration Documents.
• Responsible for review of Working standards and related documents.
• Responsible for review and approval of Change controls and verification of Action plans.
• Responsible for Compilation of Stability data and its verification/Exhibit batch sampling protocols.
• Responsible for Verification of Standard operating procedures/ Standard testing procedures/Analytical reports/ Work sheets before approval.
• Author and contribute in maintaining the Quality compliance trackers in timely manner for Corrective actions and preventive actions and follow up and closure.
• Responsible to escalate any GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
• Impact assessment reports, Risk Assessment reports, Justifications for Skipping pre-validations, validations, trials, hold time study, reduced testing proposal evaluation for the Critical Quality Attributes.
• Responsible for audit trail verification for LabSolutions and standalone instruments in QC and responsible for administrator activities for QC instruments and various software.
• Experienced in analyzing, Review of Raw Material & Finished Goods for Compliance limits.
• Experienced in operation and of HPLC, GC, FTIR, UV and other QC Instruments and Equipment’s.
• Experienced for analyzing compounds as given and interpretation of those results and analyzing and investigating the Out of Specification and Out of Trend samples.
• Experience for Documentation of Instruments (Qualifications, AMC, GLP Documents).
• Experienced Documentation like Maintaining Records of Analytical Data of Raw Materials and Certificate of Analysis Preparation and Trend Data
• Experience in internal audits and prepare audit report of various department as per the planner.

• HPLC –Waters 2695, Agilent 1100, 1200 series, Shimadzu with Empower 3.
• UV-Visible Spectrophotometer -Shimadzu 1601
• Particle size analyzer- Malvern 3000
• FTIR-Shimadzu and Agilent with IR-Solution Software
• Auto titrator -Metrohm 809+
• GC with head space- Agilent and Shimadzu with Empower and LabSolutions

2

• Date of Birth: 30/11/91
• Marital Status: Unmarried

• English
• Kannada
• Tamil

I hereby declare that the information furnished above is true to the best of my knowledge.