Saeed Emon

* Prepare, submit, and maintain Product Listing applications to the Therapeutic Goods Administration (TGA) * Preparation of Evidence package to TGA * Label development as per updated TGO 92 * Submission documentation including Declarations of Conformity in alignment with the TGA's requirements. * Assist the team with ad hoc projects in alignment with Critical Success Factors. * Support post-market activities including drafting adverse event reports for submission to the TGA. * Maintain current product registrations and assist to process registration changes when required. * Maintain regulatory trackers and manage the filing and record keeping of regulatory documentation including registration certificates.

* Team Lead of In-Process Quality Assurance (IPQA) function. * Perform all necessary tests if raw materials/packaging materials/finished product with proper documentation * Perform and monitor Process validation of solid products. * Monitor and report qualification activities of new production machine, solid facility and requalification schedule. * Prepare Process Validation/Cleaning Validation protocols and ensure/maintain its execution. * Perform internal audit and vendor audit. * Ensure GMP compliance and continuous quality improvement in the production floor. * Ensure verification of weight variation and/or other physical parameters of product from start to end of batch to comply with SOP. * Conduct Batch release and Batch History Review * Handling of Non Conformity Report (NCR) and customer complaint * Out of Specification (OOS), Deviation and Change control management. * Preparation of Quality Assurance Standard Operating Procedures (QA SOP) as per requirement * Preparation of Product Quality Review

* Prescription screening and monitoring. Review each prescription with all relevant patient information to handle and individualize drug therapy according to- the appropriateness of the drug, dose, frequency, route administration, therapeutic duplication, potential allergies/sensitiveness, potential interactions between medications or food, weight and other physiological information * Medication error Reporting- identify the medication error by checking correct drug, strength, dose, route and frequency, and report on regular basis * Prepare and/or oversee the preparation and dispensing of prescription medications * Monitor, stock and indent availability of medication, and report accordingly

* Preparation of course related documents * Co-ordinate supervisor with semester curriculum execution. * Tutoring course students on lectures and assignments * Invigilator course exams and quizzes.

Global Regulatory Affairs at Square Pharmaceuticals Limited

Activities and Societies: Official Organizing Member of Asian University of Debating Championship(AUDC)