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 Agreement, etc.). ● 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.● Allocated samples and documentation for analytical and microbiological testing as according to stability pull schedule. Maintained stability testing schedules to allow revenue forecasts and prediction of laboratory team workload.● Verified that all methods and revisions specified for test or stability samples correspondto those that have been appropriately transferred to or validated by the company. Identified discrepancies and reported on the same to the manager.● Acquired information from internal and external cross-functional teams (clients, PDS, Account Managers and Project Leaders) as applicable for the preparation of stability protocols.● Wrote stability deviations, assessed sample impact and delivered the information to the appropriate department to gain approval from the clients.● Participated in the creation and implementation of Lean initiative and continuous improvement strategies to measure and improve the efficiency of the stability program and testing.● Maintained awareness of upcoming work and provided information to Stability Supervisor to allow for optimum allocation of resources to meet commitments.

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.● Organized stability chamber and stability documents.● Performed stability sample reconciliation and disposal.● Performed photostability, Freeze and Thaw, Thermal cycling and in-use-studies.● Handled control substance.

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.• Assisted with the design review and FAT for new equipment and upgrade legacy equipment.• Executed Validation protocols.• Monitored and advised management /mechanic lead hand regarding low stock for critical spare parts as well as consumable inventory items.• Complete GMP documentation right first time in batch records and other relevant GMP documents

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.• Attended product meetings for TPD Clarifax, FDA Amendments, other regulatory agency deficiency responses and generated change controls to revise all necessary documents.• Timely response to the queries as requested by the regulatory, QA and analytical departments. • Hands on training in Over The Counter (OTC) Products, checking labels, sending samples for retest, shipping and receiving of samples and release of samples to the market.

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 and documenting to ensure GMP compliance. • 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.