Limax C.

Associate, Pharmatech @SUN PHARMA

Brampton, ON, CA

As part of the Alternate Vendor Development program team, coordinated the production of exhibit batches to qualify new alternate APIs, Excipients and Packaging materials and the documentation for regulatory submissions- Led New Product Launch of Metronidazole Cream in the US Market. Prepared Regulatory Submission Documents, carried out Submission batches and Validation batches to support the Launch- Prepared Placebo/Sensitivity Batches at Lab Scale for QCD, In-Vitro Release Tests and PharmaTech Studies- Managed the preparation of Bills of Materials (BOM) and Master Recipes within SAP for new & existing products at the Brampton manufacturing facility- Raised Change Controls for New Products/Site Transfers and Scale-ups- Created Study Protocols and Reports to study critical process parameters and process operations to control Out-of-Specification investigations- Used MINITAB and Excel\'s data analysis tool package for statistical inference to provide various justifications and for decision-making in case of OOS and OOT batches- Primarily responsible for packaging serialization and open site master database management of Prescription Products manufactured in Canada- Prepared Assessment Reports to assess the shelf life of all the packaging materials to balance the supply chain risks while maintaining quality standards- Created/updated paper-based Master Formulas and reviewed MES Recipes for various products to support Plant Automation and OpEX goals.