Mujahid Hussain

To lead and manage the strategic and operational performance of the entire quality organization across the Dynatis Pakistan (Pvt.) Ltd. (Quality Assurance & Quality Control), ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success. This position is responsible for the promotion of quality awareness and continuous improvement at the site. This position will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. This role is responsible for helping to lead teams across the site in an integrated way that supports the delivery of site business goals. For details of responsibilities and authorities, please see attached resume.

• Authorized for all authorities and responsibilities of Quality Assurance Manager. • Lead team of 25 Quality Assurance professionals. • Managed Human Resource including Hiring & staffing in Quality Assurance Department. • Prepared and managed annual departmental budgets, staff objectives & appraisals. • Developed and managed all aspects of Quality Assurance Systems comprising of In Process control. • Authorized for making decision on approval and rejection of batches and also manage final product release to the customer. • Implemented Quality Management System at the organization as per the requirement of ISO 9001:2008. • Implemented cGMP compliance according to DRAP and international Regulatory Guidelines.i.e.WHO, FDA, ICH, EMEA during manufacturing & packaging operations in all production areas. • Maintained departmental documents including policies, procedures, specifications, and methods to assure the quality of products. • Monitored & Handled Customer Complaints, Recalls (Domestic & Global), CAPA, Deviations, Self Inspections , Validations, Qualifications, Product Quality Review, Quality Risk Management and Vendor evaluation/re-evaluation system • Conducted GMP/GLP inspections, Internal Audits, Vendor Audits, GMP trainings (Technical & Soft Skills) • Handled Document Control/change control section • Implemented Robust Quality Systems and Procedures including APR, Vendor Approval & QRM system. • Handled ISO Audits, Foreign & Local Regulatory Inspections & External Audits. • Handled Queries from National & International Regulatory Authorities. • Reviewed CTD & Non-CTD Dossiers for National & International Regulatory Authorities. • Foreign & national Inspections Readiness Team Leader. • Ensured Qualifications of Equipment and machines related to Plant etc. • Conducted Contract Manufacturer/ Toll Manufacturer audits for CHC products & Key role in selection and evaluation of toll manufacturer. • Assure cGMP Compliance level at all selected toll manufacturers.

Major Responsibilities: • Research and Analytical Method Development of new products and trial products. • Preparation of SOPs of in-process and finished products and Raw Materials and packaging materials for Quality Control Department. • Sampling, analysis and complete documentation of raw materials for approval, in-process, finished products. • Performing Method, process and cleaning Validation. • Performing related compounds of products on HPLC and impurities of compounds on Gas Chromatograph. • Supervise Calibration of analytical instruments used in quality control laboratory. • Keen role in handling and educating trainees and subordinates. • Responsible for EHS and First Aid in quality control department. • Complete successfully performing all other relevant professional tasks given by higher management. • Hands-on experience with statistical data collection and quality administration. • Handle and resolve critical quality problems using research abilities. • Performing as acting manager responsibilities and lead and supervise the quality control department and coordination with all other departments of the organization in the absence of Q.C. Manager. • To ensure and control Good laboratory practices GLP in QC laboratory. • To ensure the Installation, Operational and Performance Qualifications of Equipment related to laboratory (HPLC, GC, FT-IR, AA and etc.). • Looking after General Administration of Laboratory, indenting of various Chemicals, Reagents, Equipment spares, and other lab consumables. • Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same. • To prepare departmental key performance indicator (KPI) and all documentation relevant to export products.

Major Responsibilities: • Research and Analytical Method Development of new products. • Preparation of SOPs of in-process and finished products and Raw Materials for Quaility Control Department. • Sampling, testing, analysis and complete documentation of raw materials, in-process, finished products. • Method and process Validation. • Independent and self-directed – Can work with minimum supervision. • Strong analytical skills, combined with effective communication, organizational skills and planning ability. • Handle and resolve critical quality problems using research abilities. • Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same. • Performing all responsibilities of a QA officer. • Perform all chemical and physical testing of WFI, Purified water and Tap water.

Major Responsibilities: • Research and Analytical Method Development of new products. • Preparation of SOPs of in-process and finished products and Raw Materials for Quaility Control Department. • Performing analysis of new launched products and trial products and keeping all stability testing record of the products at room temperature and also at accelerating temperature and moisture conditions. • Handle and resolve critical quality problems using research abilities. • To monitor Control samples of Finished Products and scheduling of Accelerated and long-term Stability Studies. • Preparation, Maintenance and Record keeping of volumetric solutions and other Laboratory Reagents.