Athar Ali Email & Phone Number

Dubai, Ae

Dubai

Key performance area: Business Performance & Building business objectives►To determine appropriate strategy and approach for Quality improvements and internal processes to optimize output efficiency and removal of non-value added activities. ►To participate in customer satisfaction survey study and annual high-level business risk assessment program to analyze inherent risk related to strategic business objectives and to extend assistance in developing and implementation of risk mitigation plan.►To develop, implement, communicate and maintain a quality plan to bring the company’s quality systems and policies into compliance with quality system requirements.►To manage Quality Assurance & Pharmacovigilance functions to ensure highly disciplined compliance with all the products, as per standards legislation, defined policies and identified process quality parameters.Key performance area: Quality Assurance and Stakeholder’s Relations►To review and approve SoPs , Quality assurance technical agreement and extend assistance to stakeholders to develop effective training programme for their subordinates..►To handle all external audits independently and conduct an internal audit for all the operational and functional divisions including 3rd Party warehouse as per GMP, GDP Standards and ISO 9001:2015 standard.►To Oversee investigation, root cause analysis and closure of NCR's raised during internal and external audits.► To Oversee investigation, root cause analysis and closure of Customer Complaints and handling of quality related issues of all division.►To handle Product recalls, damaged & return products on account of quality issues if any and communicate the same to business partners accordingly.Key performance area: Leadership & Quality:►To prepare formal reports for senior management expressing an opinion on the quality of control systems and incorporating agreed solutions to process gaps.

Dubai-Uae

Regulatory strategies:►Overall management of registration of personal care consumer, OTC Products & support for ethical products registration►To review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness and compliance with regulatory standards.►To liaise with respective principal’s company regulatory team on account of registration dossier submission & written response to technical queries raised by registration authority during registration phase.► To coordinate & follow up with MoH -UAE, Consumer registration safety Dept,Food control dept & other relevant authorities during the course of product review till an approval of all ongoing projects is obtained.►To generate reports, documents and information that allow the functional team to more effectively manage the business from regulatory perspective.►To support maintenance of marketed products (including product maintenance as manufacturing or labeling variations, renewals, etc.)Setup, mangement & Enforcement of Quality & PV System:To determine appropriate strategy (Business continuity programme BCP) and approach for Quality, Process & Pharmacovigilance Improvement:►To manage Quality assurance & Pharmacovigilance functions to ensure highly disciplined compliance with all the product, process quality parameters and standards.►To liaise during audits from principals company & other external audits & follow-up with the different departmental head for effective implementation of Corrective and Preventive Actions►Oversee investigation, root cause analysis and closure of market complaints and aduit NCR's.►To train stakeholder's with regrad to Quality policies, ISO ,GDP norms & Principal company's requirements inline with PV to meet and enhance the compliance in all respects.

Dubai

Develop regulatory strategies and implementation plans for the preparation and submission of registration dossiers.Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained.Provide regulatory guidance to brand team, project development teams regarding design, development, evaluation & labeling requirements of products. Liasion with regulatory authorities of GCC,MENA,Canada & EU regions to obtain timely product registration certificate.Implement QA systems and generate SOPs.Handling of MWT(Master Work Flow Tool) for creation of RM,PM and FG code .Handling of QM module in SAP -BoM creation and revision ,Uploading of RMs/PMs/FGs specification , generation of rejected reports. Manage activities such as Quality audit /EHS/DMs audits, regulatory agency/Accredited authority (SGS,Intertek,) inspections,market complaints and product recalls.

Saudi Arabia

Participation in a development of quality control program for the factory and to review Quality assurance & Quality control documents including SoPs, In process check records, Validatio & Qualification protcols.Quality assessment of finished products and compilation of defective analysis on case to case basis.Contribution in the researches, statistical and feasibility studies and development to ensure continuous quality programs improvements across company products.

Vapi ( Gujrat)

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, First

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, 1St