Sivaji Magham Email & Phone Number

Mississauga, ON, Canada

• Prepared stability protocols for commercial products, generated associated change controls for different markets and clients with global stability regulations and ICH guidelines.
• Requested stability batches and stability samples as required for stability programs for global markets.
• Prepared new and revised stability protocols for Formulation and development products.
• Ensured that all regulated operations in the area of responsibility are adequately described by writtenprocedures and that all operations are performed according to the written procedures (SOPs, Protocols, Quality.
• Organized meetings to finalize creation, review and approval of Stability documents.
• Effectively participated in global regulatory agencies inspections, including FDA, Health Canada and other regulatory agencies.

Mississauga, ON, Canada

• Performed daily stability sample pull as per pull list.
• Assigned samples for Analytical and Microbiological testing.
• Prepared required documentation and allocated samples for outsourced testing.
• Performed stability sample incubation, including labelling placing samples in chambers, verifying sample count, updated logbooks.
• Consolidated completed stability study protocols and Stability interim summary Reports.
• Monitored stability chamber charts on a daily basis and reported non-compliance.

Toronto, Canada Area

• Precision set up of printing and vision inspection system for serialization products.
• Follow defined process for MES and SAP.
• Developed and executed continuous improvement projects with a focus on improving safety, quality and efficiency.
• Assisted with the training of new hires line service technicians, operators and mechanics.
• Provided training and guidance to line operators and line technicians ensuring the equipment is operated in a safe manner.
• Provided troubleshooting training to line service technicians and operators to minimize intermittent downtime.

Mississauga, ON, Canada

• Knowledge of laser labeller, Langden Cartoner, Scandia Overwrap and Edson case packer.
• Operating equipment, visual line inspection, starting and stopping machine, line clearance.

Mississauga, Canada

• Maintained, controlled and update stability samples for marketed and R&D batches in the chamber to ensure effective and accurate distribution of stability samples.
• Registered, reviewed and approved marketed and R&D products in the stability database using Laboratory Information Management System (LIMS) program to ensure accurate data entry and reports for different departments.
• Coordinated and attended product meetings to finalize draft protocols for new and revise stability protocols for marketed and R&D products and generated change controls.
• Updated and tallied inventory of stability samples of marketed and R&D products using LIMS program and Excel database spread sheets.
• Generated monthly and weekly retrieval schedules for effective delivery of samples to analytical laboratory.
• Initiated Deviation Reporting (DR) for the deviations in the stability program for corrective actions to be taken.

Toronto, Canada

• Maintained Front Office, Cash Register and Customer Service.
• Effectively handled high customer volumes of approximately 150-200 per day to ensure customer loyalty and repeat business.
• Maintained good housekeeping procedures.

India

• Worked in Tablets department and was responsible for Manufacturing and Packaging Line process controls, Documentation and implementation of cGMP norms.
• Preparing a Monthly Material requirement plan (MRP) according to rolling production plan for procurement of materials.
• Handling Non-Compliance reports from QA if any and rectifying the same.

India

• Involved in manufacturing activities, troubleshooting, stage wise yield calculation, label and, weigh finished products as per SOP’s and Documentation.
• Well experienced in Cleaning, Setting, Operating and labeling of various machinery.
• Performed In -process quality control checks (IPQC) in manufacturing and Packaging with respect to appearance, Weight variation,Hardness, Thickness, Friability, Disintegration sealing, batch coding details, leak test.
• Perform daily maintenance as required of pharmaceutical manufacturing equipment and premises to ensure GMP compliance.
• Provide feedback on process and procedure to facilitate efficiency improvement.
• Involved in daily and reviews of plan (vs.) actual within the department and peers.