Muhammad Ashraf

• To ensure that all necessary testing is being carried out in strict pursuance of Standard Testing Methods (STM’s) and Standard Operating Procedures (SOP’s). • To review and approve SOP’s, specification sheets and MOA’s. • To review and evaluate all data generated by QC laboratories and accordingly accept / reject Raw Material, Packaging Material and Finished Products through review and approval of Analysis Reports and COA’s. • To approve Installation / Operation and Performance Qualification Protocols and Reports for new equipment. • To review and approve Process Validation Protocols and Reports. • To ensure integrity and traceability of all data generated. • To prepare the Stability Study Protocols for new products & review the products quality through stability studies. • To make sure the preparation and performance of analytical method validation. • To increase the QC teams awareness in the drug manufacturing process by establishing internal and external training programs that shall target critical areas to ensure integration of quality in every production function. • To identifying relevant quality-related training needs and delivering training. • Ensures that all standards, reagents, solvents and other chemicals are properly prepared, maintained and used. • To handle troubleshooting instrumental and analytical problems. • To perform periodical employee appraisal for subordinates. • To performs investigations to evaluate out-of-specification results and documenting and Implementing of Out Of Specification (OOS) system.

• Responsible to ensure all aspects of Quality Assurance Systems comprising of In Process control. • Responsible for making decision on approval and rejection of batches and also manage final product release to the customer in absence of GM QA. • Responsible to implement Quality Management System at the organization as per the requirements of ISO 9001:2008. • Ensure cGMP compliance during manufacturing and packaging operations in all production areas. • Responsible to maintain departmental documents including policies, procedures, specifications, and methods to assure the quality of products. • Deal with customer complaints and generation of CAPA if required. Also ensures maintenance of Customer Complaint Log. Responsible to monitor deviation in the batch/processes and its approval and recording. • Responsible to Conduct GMP/GLP inspections, internal audits, according to schedule and ensure the compliance of procedures, SOPs, in all technical departments. • Responsible to conduct trainings and maintain record of all staff. • Responsible to coordinate with procurement Department in conducting supplier audit/inspection and making its report. • Responsible for ISO Audits, Foreign & Local Regulatory Inspections. • Supervise Document Control Department and assist Management Representative. • To ensure the DQ, IQ, OQ, PQ of equipments and machines related to QC, Production etc.

• Perform analytical testing of raw materials, in-process and finished products by HPLC, AAS instrumentation and other wet chemical analysis. • Record all results in laboratory notebook and/or electronic files following the appropriate SOPs. • Write and review SOPs, protocols, reports, and support regulatory submissions with high quality analytical documentation. • Record, report and investigate non-conforming materials results (OOS) to supervisor in a timely manner. • Prepare and standardize laboratory reagents according to written procedures. • Ensure laboratory area is maintained in a GLP/GMP state at all times and that all equipments are calibrated and maintained as prescribed prior to use. • Develop, optimize, and validate analytical methods.

• Perform sampling & testing of raw materials and packing materials as per established procedures and laboratory methodology to ensure conformance with approved specifications. • Samples and tests In-process and finished products according to established procedures and approved specifications. • Preparation of Laboratory analytical reagents, test and volumetric solutions. • Testing of purified water according to USP/BP specifications. • Ensure good housekeeping in the laboratory. • Maintains inventory on glassware, laboratory equipments, chemicals and reagents. • Ensures that all chemicals, reagents and solutions are properly labeled and expired items are removed from use.