Amit Agarwal Email & Phone Number

Brampton, On, Ca

Vaughan, Ontario, Canada

Vaughan, Ontario, Canada

* Oversees all aspects of Quality functions to provide products of the highest quality.* Hosted HC audits, Medical Device audits, PMRA audits, Pharmacovigilance audits.* Hosted 3rd party audits (OTC, Cosmetic, ISO) with all the major audit firms.* Ensures Product compliance with market authorization, specifications or monographs, as applicable.* Incorporate Quality requirements and applicable local Quality standards (e.g. GMP, cGMP, ICH) and regulations into policies and procedures (SOP).* Monitors and ensures third party compliance on an ongoing basis. e.g. QA agreements, audits with appropriate follow up, risk assessments, and follow up stability.* Maintains company's DEL, Site Licence and Product Licence.* Handles Ingredients and Product testing and approvals for new and existing products.* Oversees the planning, communication and execution of QA Audits and Self - inspections and approves sub-contract manufacturers.* Manages Product Recalls.* Ensures timely compilation and thorough assessment of APQR.* Ensures technical complaints are timely investigated and follow-up actions (e.g. CAPAs, change control, market actions) are timely implemented and their effectiveness assessed.* Provides QA support for allocated projects, related to Quality, Operational effectiveness and current GMP compliance.

* Ensured departmental compliance with HC & FDA and internal policies and procedures, and that all industry regulatory announcements are received as issued.* Supports review and approval of Ingredient labeling requirements for Canadian and US market products by ensuring those used in Finished Product will meet safety and purity standards.* Coordinate and review batch documentation from factories and test lab.* Perform warehouse product inspection and coordinate off-site product inspection program.* Assemble and review post-approval changes to ensure compliance throughout product life cycle.* Responsible for on-line FDA drug product listing.* Responsible for on-line cosmetic notification to Health Canada.* Contribute essential expertise to the development of testing program structures across products and parameters to be tested by 3rd party laboratories, reviewing results and performing trending analysis.* Approves or Rejects products for sale including the initiation and follow up of investigation, relying upon communication with management, carrier and manufacturers to deduce the root cause of non-compliance.* Manage Stability program includes Sampling, tracking and Analysis.* Responsible for essential and logical planning and auditing of suppliers (schedule and follow-up).* Performs product label review and participate in change control and the quality program.* Prepare and maintain master product files and review retailer product specifications.* Coordinates production samples for retention, conformatory and stability testing.* Performs all work in accordance with established regulatory, compliance and safety requirements.

Quality checks on Raw Materials and Finished productsFollow the HACCP Plans and Pre-requisite programsPerform Inspections / Internal Audits according to written programs and documents results and corrective action in prescribed formatPerforms Pre-Op inspection of all equipment in manufacturing rooms prior to production start upPerforms Pre-op inspection of all coolers, freezers and areas that support production prior to production start upResponsible for writing daily Pre-Op reports to the Plant Management teamAnalyze/Trends the data from Pre-Op, ATP testingPerforms SSOP AuditsPerforms Organoleptic EvaluationImplements the Hold procedures for suspect product and or product evaluations and testingMaintain all Pre-requisite and CCP monitoring formsPerform various HACCP related verification activitiesFollow up on any necessary corrective action items associated with the auditsCo-ordinate with orientation training, CCP training and annual GMP training

Sampling of Materials as per the SOP.Conduct Testing and Documentation of product quality as required.Inspection of any Damaged/Cracked components, holes in bottle/leakers, damaged threads broken or missing, dented bottles, part line mis-match, discoloration, small carbon spots of the Bottles, Caps and Plugs and reporting to the Supervisor and Documentation as per the SOP (Major/Critical/Minor)Sampling of Caps and Plugs in the Sampling Booth with wearing proper gowning as per the SOP.After Sterilization of Bottles doing Heightened Test as per the SOP. Looking for any Particles, irons, metal pieces and reporting to the Supervisor.

Trained employees for CNC machine operationsSet up and maintained tools of different sizes and shapesResponsible for meeting customer requirements as per product qualityResponsible for ensuring the daily production activity reports are accurate and completed in a timely mannerResponsible for continuously improving production

Produced analytical reports that are documented in accurate and lucid format Reviewed documentation, analyze historical data (deviations, analytical failures, OOS) to detect / establish trendsEnsured records of all investigations are properly and adequately maintained and filed appropriately in accordance with approved company proceduresInterpreted data and completed written reportsImplemented Standard Operating Procedures (SOP) for various instruments Maintained proper documentation for instrument maintenance and Sample ProcessingPrepared Supplier Quality Assessment (SQA) reports, SPC and control chartsPrepared NCMR(Non Conformance Material Request) and QAR(Quality Action Request) for Quality related issuesPrepared Daily, Monthly and Yearly reportsInvolved in Internal Audits and as well as ISO Audits

Post Graduate, Pharmaceutical Quality Assurance & Quality Control And Regulatory Affairs

B.Sc, Chemistry