Responsibilites To monitor the International Regulatory Affairs matters and prepared the dossiers for international market To ensure the compliance of Quality Management System (ISO 9001:2015) and Environmental Management System (ISO 14001:2015). To Prepare and maintain Validation master plan for the facility, and ensure the conduction of the process validation, cleaning Validation, Area Qualifications and Equipment Qualifications. To supervise the Quality Assurance Processes (Line clearances and In-process controls in manufacturing areas) and manage the deviation and non conformances as per international guidelines. To ensure the compliance of entire plant with cGMP standards. To monitor and manage the Product Quality Review of products. To ensure the implementation of training program for employees. To ensure the implementation of document control and change management system. To ensure the implementation of vendor evaluation system and responsible conducting the audits as per plan. Involved in the process improvement, joint ventures and vendors coordination and responsible for facilitating the audits, preparing inspection plans and corrective actions preventative actions (CAPA)

ResponsibilitiesI worked as GMP Auditor at its Business Risk Advisory Department. I was engaged in the project of “Inspection of Drugs Manufacturing Facilities for Verification of Compliance of Good Manufacturing Practices and Standards” initiated by Primary and Secondary Healthcare Department - Government of Punjab (Pakistan). In this project I was working within the capacity of Team Leader and responsible to perform following tasks: Supervise team of pharmacists to assure that cGMP - Inspections of pharmaceuticals manufacturing units are conducted in rescribed manner.Assure that GMP Inspections are executed according to predefined plans and deadlines are duly met; Execute closing meeting with Pharmaceutical Unit's management and represent EY in these meetings; Supervise overall process of audit report writing and assure that audit observations of all areas are compiled in the final report; Check the quality standards according to cGMP Checking the Production, Quality assurance, Supply chain departments and assure their GMP compliance. Cross-verify the testing and manufacturing procedures and assurance of quality from all aspects. Act as a member of Quality Assurance team to critically evaluate the inspection reports submitted by teams.

Responsibilities To ensure conformable & timely all the in process services before start-up of all the operational activities. Perform and monitor all the In Process Quality Checks in Cephalosporin Area (Tablets Capsule Sterile and Dry suspension ) and Liquid Injectable section (vials and Ampoules) Maintain the Batch Manufacturing Record. Complete checking the BMR after packing & release the batch. Maintain the Documentation of calibration records. Planning and undertaking the GMP inspections Performs Equipment Qualifications and prepares their reports Prepare annual Departmental Training Plan. Ensure implementation of Deviations and CAPA system in all GMP regulated department