Aasefa Shaikh Email & Phone Number

Whitby, On, Ca

Mississauga, On, Ca

• Providing guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance.• Ensure regulatory compliance of the operation with current government regulations, agency guidelines and internal policies through internal inspections and audits.• Identify risks and develop risk mitigation plans and project plans.• Create, review, and/or approve quality reviews and regulatory submissions including license renewals, permit applications etc.• Classify new and existing products according to controlled substance regulations.• Submit monthly inventory report for controlled substances and monthly inventory reports and B-300 reports for cannabis• Maintain inventory and transfers of controlled substances and cannabis • Create and reviews internal documents for e.g. Standard Operating Procedures (SOP), etc. to ensure alignment with current practices and to ensure quality across internal operations. • Lead audit team member during health Canada inspections

120 Newkirk Rd., Richmondhill, On

• Develop, establish and maintain quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of compounds substance conform to established standards, specifications and regulatory requirements through internal audits; quality documentation review; root cause analysis & CAPA resolutions.• Conduct laboratory documentation compliance audits on all projects (organic compounds and cannabis) and instrument performance verification/ qualification reports. • Ensure regulatory compliance of the operation with current government regulations, agency guidelines and internal policies• Ensure compliance with current ISO 9001 & ISO 17025 standards.• Lead audit team member during external quality audits and site inspections by regulatory agencies; host external audits by license partners. • Ensure that internal inspections and internal audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. • Create, review, and/or approve quality reviews including COA, reports, methods, specifications etc.• Maintain document change control system• Create and/or reviews and/or approves internal documents for e.g. Standard Operating Procedures (SOP), etc. to ensure alignment with current practices and to ensure quality across internal operations. • Organize TWI training for new employees and maintain training plan and training record.

Implementation of GMP guidelinesMaintain and monitor GMP documentation, change control and training record systems. Assist in generation, review, approval and distribution of CCRF and GMP documents (SOP, GM, CP, TM, Protocols, and Specifications)AQL inspectionAudit and inspect laboratory operation and activities Audit laboratory equipment log books, documentation and chart recordersAudit preparation of qualification solutionsAudit equipment calibration, qualification/verification documents and annual qualification/validation of HPLCRelease laboratory equipmentMonitor, maintain, oversee removal of and keep inventory of standards (calibration, reference), samples, API/ExcipientPrepare and issue CofAsMaintain DMFsOversee removal of samples from stability chambers Review internal logbooks for incoming samples, standards, reagents, equipment etc.Self-inspection of standards, documentation, equipment and laboratoryQualifications of technical personnel Preparing for FDA and Health Canada audit (project and GMP based) Manage electronic filing of calibration and validation results sheets, certificates of calibration, CofAs and any other quality documentationReview GMP document (CofAs, specification, test methods) from CMOs

Perform all work in compliance with current SOPs and GMPsPreparation of documents (SOPs, TM, GM, CP, Reports etc.)Filing of DocumentsGenerate certified copiesPrepare Certificate of AnalysisPrepare shipping documentation and ship samples for testing, and calibration standards for calibration Scan laboratory and inventory log books, calibration and validation results sheets Perform additional duties as assigned

• Respond to customer complaints and diffuse problematic situations ensuring safety and customer satisfaction• Supervise floor staff ensuring operations and flow of work is efficient and safe• Balance cash at end of shifts and prepare bank deposits• Open and close restaurant including necessary paperwork and cash settlements

Conducting research focusing on the dynamics of Schizosaccharomyces pombe La in the absence and presence of RNA, using Electrospray Ionization Mass Spectrometry and microfluidics enabled Hydrogen-Deuterium Exchange

• Making patients feel comfortable and at ease. • Administered pre meds to patients 45 min prior to examination• Help deliver nitrous oxide and sedation• Preparation of the surgery prior to patient’s arrival.• Assisted in amalgam and composite resin restorations, crown and bridge, invisalign, veneers, sealants, root canal therapy, implants, • Mixing fillings and materials. • Constructing dental impressions, bite registrations and pouring up models• Took, developed and mounted x-rays using x-ray machine and the panoramic machine. • Sterilizing equipment and ensuring all equipment is ready and the waiting area is clean. • Amending patient records and taking down notes that are dictated by the dentist. • Organizing and filing patient records. • Calling patients for post op check up• Prepared patients for dental care service, executed laboratory works, maintained dental equipment in good condition

Bachelor Of Science (B.Sc.), Biochemistry

• On Deans Honor Roll • Recipient of York University Continuing Student Scholarship • Completed full year thesis in the dynamics.

Dental Assistant, Dental Assisting/Assistant

• On Deans Honor Roll • Completed 70 hours in dental practice