Muhammad Majid Email & Phone Number

Toronto, On, Ca

Mississauga, Ontario, Canada

Client Management for the market release of Natural Health Product (NHP) & Drug products (DIN) as per Health Canada regulations. Preparation/ review of Master batch records, Approved artworks, Standard Operating Procedures, product specifications & stability protocol/ reports for regulatory submission as well as product launch in Canadian market for NHP & DIN products. Conduct self inspection & audits of client’s sites with report writing & CAPA implementation. Preparation & review of change Control, Deviation, Risk Assessment, OOS investigation, CAPA Management for regulatory & quality compliance.Document preparations for Health Canada applications to support the product licensing (PLAs), Information Request Notices (IRN’s) & Clarification requests (CRs) of natural health products in accordance with the Natural Health Products Regulation.Assists & implement label revisions due to regulatory changes, formulation changes and filing amendment and notification forms (ANF) to Health Canada.Assist Regulatory team in preparation and submission of Drug Establishment License (DEL) and Annual Drug Notification Form (ANDF).

Karāchi, Sindh, Pakistan

- Assurance of QMS & GMP Compliance at contract manufacturing sites through process monitoring & Inspections. - Plan & conduct formal audits of all technical areas with report writing, issuance & follow up for CAPA. - Plan & conduct formal audits of Raw and PKG material vendors/ suppliers with report writing, issuance & follow up for CAPA. - Plan & conduct Distributor & stockiest audits and follow up of their relevant corrective and preventive actions. - Plan & conduct audits of third Party Service Providers to ensure compliance of quality standards. - Develop & maintain quality agreements for all outsource business activities including Contract Manufacturers, raw & packaging material vendors, Distributors, sub-contracting laboratories & service agencies. - Approval of finished pharmaceutical products through batch records & analytical reports audits for timely market dispatch. - Transportation & Distribution studies of marketed products to evaluate product quality, integrity & stability throughout the transportation & distribution chain. - Product quality defects handling & investigation with implementation of Corrective & Preventive Actions. - Development, revision & review of the relevant Standard Operating Procedures, Policies & manual to ensure compliance with GMP & updated international guidelines. - Coordinate with all other technical departments for regulatory inspections (Local & International).- Training and certification of team members/ direct report’s for the execution of their job independently after completion of successful training. - Change control management with Risk Assessment at contract manufacturing sites to ensure compliance of regulatory & quality requirements.- Ensure CAPA (Corrective and Preventive Actions) are appropriately determined in response to audits, self-inspections, incidents, customer complaints and deviations.

Karachi, Pakistan

- Ensure the compliance of GMP at Contract Manufacturer Sites during production activities, Storage & warehousing, Quality control testing & documentation. - Improvement in Quality Management system with the development, review & follow up at Contract Manufacturing sites. - Conduct audits of Packaging Materia Vendors to ensure compliance with GMP, GSP (Good Storage Practices) and other regulatory requirements. - Evaluation of product quality, integrity & safety throughout the transportation & distribution chain through transportation studies. - Product technical complaints investigation & correspondence. - Auditing of batch records & dispatch to the market through verification of critical process parameters. - Development, revision & review of the relevant SOP’s to ensure compliance with GMP & International standards- Assessment & control of Risk in critical areas & processes with the utilization of Risk tools. - Root Cause Analysis & CAPA Implementation for their progress monitoring and regular reporting of the required actions. - Failure Investigation Management with their impact assessment, and closing within defined time frame with the required corrective & preventive actions. - Deviation handling & Change Control Management for appropriate handling, evaluation, documentation and authorization of the required changes. - Product technical complaint investigation in coordination of technical departments and implementation of recommended CAPA.- To coordinate with technical departments for Regulatory Inspections (local and international).- Review & rectification of Annual Product Review findings for continuous improvement.- Change control assessment & implementation of required changes at production areas.

Karāchi, Sindh, Pakistan

- Lead the QA & Compliance in Production Areas of Oral Solid Dosage, Sterile, and Penicillin & Cephalosporin Manufacturing & Packaging Areas for In-Process Monitoring & control. - Assure GMP in Manufacturing, Packaging, Warehouse & storage areas through self-inspections & routine inspections.- Product Failure & non-compliance investigation with root cause analysis and implementation of CAPA through proper documentation.- Develop annual training calendar & conduct training as per plan for all SOP’s & GMP topics. - Development of In-Process specifications & standards for all production areas. - Development & revision of Standard Operating Procedures (SOP’s) to ensure compliance with GMP standards. - Batch Manufacturing Records (BMR) & Batch Packaging Record auditing & reviewing.- Critical monitoring, sampling & reporting of validation batches as per standard protocols.- Conduction & assessment of Area & Equipment Qualification studies & Machine Trials for packing components.- Collection of in-process, validation, stability & reference samples. - Ensure Compliance of SOP’s in production areas and timely reporting & rectification of non-compliances. - Calibration and daily verification of all In-Process lab Equipment’s on regular interval basis. - Ensuring periodic Validation and Re-Validation activities related to Process and Equipment’s/Instruments whenever required.

Karāchi, Sindh, Pakistan

In-process control in Production Facilty (OSD, Sterile & Penicillin) for Regulatory, Quality & cGMP compliance in manufacturing, encapsulation, filling, blistering & Packing Areas. Handling of all In-Process related issues on shop floor till rectification and timely reporting & rectification.Calibration & maintenance of In-Process Lab Equipments.Ensure that all cGMP related Changes are appropriately handled, evaluated, documented and authorized through change control evaluation system.Root Cause Analysis & CAPA Implementation for their indexing, analysis, progress monitoring and regular reporting through proper documentation. Evaluation & implementation of risk assessment in critical production process.Auditing of Batch Documentation, Batch Manufacturing Records (BMR) & Batch Packaging Record auditing & reviewing. Development of new SOPs for QA & Production functions and to revise & review existing SOP’s for aligning with Global Quality Directives.Annual Product Review, Reviewing & rectification of APR findings for continuous improvement.Handling of Market Complaints of Local and Export Countries and corresponds them under assistance of Manager QA.

Karachi

In-process control in Production Facilty (OSD, Sterile & Penicillin) for Quality & cGMP compliance in manufacturing, encapsulation, filling, blistering & Packing Areas. Check the compliance of SOP’s in production areas with proper reporting.Agile enough to handle all IPC related issues till rectification on shop floor.Review and approve IPC Report timely.Maintain IPC Lab and related instruments in good working condition and ensure their calibration as per schedule.Conduct self inspection for continuous improvement.Auditing of Log guides and Batch Manufacturing record. Development & revision of SOP's & formats. Training of technical staff for continuous improvement.

Karachi

Monitoring of GMP Compliance in Plant.Issuance of Batch Documents BMR's & BPR's.Awarding of Line Clearance at different stages of Manufacturing.Review of Artworks as per Respective Labelling & Regulatory Guidelines.Routine-In-Process Checks on Granulation, Tablets Compression, Coating, Dry Powder Filling, Sachet Filling, Capsules Filling, Liquid Filling & Packaging Areas.Monitering, Auditing & Retention Of Batch Documents.Collection, Retention & Record Keeping of Reference Samples.Preparations and looking in for Batch Protocols, Deviation Record, Change Controls...Final Batch Release.

Karachi, Pakistan

worked in Quality control & Quality Assurance Departments .. Production Department .. Dispensing Of Raw Materials for Production..Learned about EHS Measures ..

Postgraduate Diploma, Quality Assurance & Regulatory Affairs

Master Of Business Administration - Mba, Supply Chain Management

Doctor Of Pharmacy - Pharmd, Pharmacy