Jawad Ur Rehman Bajwa

Shrooq Pharma is group of companies dealing in other businesses as Honey Value Addition Unit, Nutraceuticals, Cosmetics and API manufacturing.

Ph.D Chemistry

• Validation Activities i.e. Cleaning Validation, Process Validations, Equipment Qualifications. • Temperature Mapping Studies & Warehouse Qualifications • Calibration & Area Qualifications studies • Audits i.e. Conducts & Monitor cGMP, QMS, LMS, EMS audits. • Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies during in-process control. • Documentation Control • Annual Product Review of products manufactured • Head In-process control checks of Production area. • Handling internal and external complaints through investigations. • Conduct cGMP internal audit and also Batch Manufacturing Record auditing. • Review batch records to ensure correctness, completeness, and cGMP compliance. • Maintaining requirements for International Standards through effective compliance system. • Planning & implementing the activities of Quality Assurance. • Monitoring & Evaluation for completion of tasks assigned. • Assurance of deviations for their complete documents. • Assurance for compliance of cGMP standards. • Development, archiving, distribution and withdrawl of documentation for Q.A and Production & Validation department. • Developed annual training schedule, annual medical schedule, annual Calibration-validation plan and Annual preventive maintenance schedule. • Execution of Master Validation Plan. • Qualification studies of all equipments/instruments, HVAC, Compressed Air System & Water Treatment System • Perform vendor evaluation & qualification through vendor evaluation audits • Delivering trainings at plant for different motivational & technical topics.

• Validation Activities i.e. Cleaning Validation, Process Validations, Equipment Qualifications. • Calibration & Qualifications studies • Audits i.e. Conducts & Monitor cGMP, QMS, LMS, EMS audits. • International Regulatory Affairs i.e. Dossier submission for export purposes (CTD). • Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies. • Documentation Control • Annual Product Review of products manufactured • Head In-process control checks of Production area. • Handling internal and external complaints through investigations. • Conduct cGMP internal audit and also Batch Manufacturing Record auditing. • Review batch records to ensure correctness, completeness, and cGMP compliance. • Maintaining requirements for International Standards through effective compliance system. • Planning & implementing the activities of Quality Assurance. • Monitoring & Evaluation for completion of tasks assigned. • Assurance of deviations for their complete documents. • Assurance for compliance of cGMP standards. • Development, archiving, distribution and withdrawl of documentation for Q.A and Production & Validation department. • Developed annual training schedule, annual medical schedule, annual Calibration-validation plan and Annual preventive maintenance schedule. • Execution of Master Validation Plan. • Qualification studies of all equipments & instruments HVAC & Water Treatment System • Perform Annual Product Review for products being manufactured. • Perform vendor evaluation & qualification through vendor evaluation audits • Delivered trainings at plant for different motivational & technical topics.

•Head responsibility for QA for all Basic Preparations & Formulations. •Monitoring of QA Activities for Bulk Manufacturing of Paracetamol, Ciprofloxacin HCl, Aspirin, Ampicillin & Amoxicillin (APIs). •Monitoring the execution of Training Schedule for whole plant. •Approval & final release of products through investigation of QC testing procedures and BMR compliance assurance. •Planning & execution of the capacity enhancement for basic manufacturing plants. •Collaboration as technical observer with PNAC for auditing ISO 17025 surveillance audits. •Monitoring stability studies of basic & formulation products through its shelf life as per protocols. •Key responsibility for cGMP & Integrated Management System (IMS) for ISO 9001:2008, ISO 14001:2004 & ISO 18001:2007. •Key responsibility for Internal & external Audits (3rd party audits) for GSK & Reckit, Merck etc. •Validation Activities i.e. Cleaning Validation & Process Validations •Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies •Annual Product Review of basics and formulation products manufactured. •Head In-process control checks of Production area •Handling internal and external complaints through investigations •Review batch records to ensure correctness, completeness, and cGMP compliance •Planning & implementing the activities of Quality Assurance •Assurance of deviations & change controls for their complete documents •Development, archiving, distribution and with drawl of documentation for Whole Plant •Develop annual training schedule-medical schedule-Calibration-validation plan & preventive maintenance schedule •Qualification studies of all equipments & instruments HVAC & Water Treatment System •Perform Annual Product Review for products being manufactured at CITI Pharmaceuticals •Perform vendor evaluation & qualification through vendor evaluation audits •Delivered trainings at plant for motivational & technical topics •Auditing & archiving of Batch Manufacturing Records

• Validation Activities i.e. Cleaning Validation, Process Validations, Equipment Qualifications. • Calibration Activities i.e. all calibrations of the plant for cGMP, ISO 17025 purpose. • Audits i.e. Conducts & Monitor cGMP, QMS, LMS, EMS audits. • International Regulatory Affairs i.e. Dossier submission for export purposes (CTD). • Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies. • Documentation Control of whole plant. • Annual Product Review of products manufactured by Saffron. • Head In-process control checks of Production area. • Handling internal and external complaints through investigations. • Conduct cGMP internal audit and also Batch Manufacturing Record auditing. • Review batch records to ensure correctness, completeness, and cGMP compliance. • Actively conducted certification audits of ISO-9001, 14001 & 17025. • Maintaining ISO- 9001, 17025 and 14001 requirements through effective compliance system. • Planning & implementing the activities of Quality Assurance. • Monitoring & Evaluation for completion of tasks assigned. • Assurance of deviations for their complete documents. • Performing all the validations and calibration at plant. • Assurance for compliance of cGMP standards. • Development, archiving, distribution and withdrawl of documentation for Q.A and Production & Validation department. • Developed annual training schedule, annual medical schedule, annual Calibration-validation plan and Annual preventive maintenance schedule. • Execution of Master Validation Plan. • Qualification studies of all equipments & instruments HVAC & Water Treatment System • Perform Annual Product Review for products being manufactured at Saffron Pharmaceuticals. • Perform vendor evaluation & qualification through vendor evaluation audits • Delivered trainings at plant for different motivational & technical topics. • Auditing & archiving of Batch Manufacturing Record.

*Validation Activities i.e. Cleaning Validation, Process Validations, Equipment Qualifications. *Calibration Activities i.e. all calibrations of the plant for cGMP, ISO 17025 purpose. *Audits i.e. Conducts & Monitor cGMP, QMS, LMS, EMS audits *International Regulatory Affairs i.e. Dossier submission for export purposes *Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies *Documentation Control *Annual Product Review

Working with one of the leading pharmaceutical manufacturer of Pakistan certified by ISO 9001-2008, 17025, 14001 standards, having wide range of products in different dosage forms e.g. Tablets, Dermatological, Capsules, Syrups, Suspensions and Injectables etc., being marketed locally and internationally. Posted in in-charge Validation & Compliance QA with following responsibilities: • Successfully completed Quality Management System Lead Auditor Course conducted by SGS. • Developed water treatment spectrophotometer analysis method at Saffron Pharma. • Head In-process control checks of Production area. • Handling internal and external complaints through investigations. • Conduct cGMP internal audit and also Batch Manufacturing Record auditing. • Review batch records to ensure correctness, completeness, and cGMP compliance. • Actively conducted certification audits of ISO-9001, 14001 & 17025. • Maintaining ISO- 9001, 17025 and 14001 requirements through effective compliance system. • Planning & implementing the activities of Quality Assurance. • Monitoring & Evaluation for completion of tasks assigned. • Assurance of deviations for their complete documents. • Performing all the validations and calibration at plant. • Assurance for compliance of cGMP standards. • Development of documentation for Q.A and Production department. • Developed annual training schedule, annual medical schedule, annual Calibration-validation plan and Annual preventive maintenance schedule. • Presently working on cleaning validation studies & Master Validation Plan. • Qualification studies of all equipments & instruments HVAC & Water Treatment System • Perform Annual Product Review for products being manufactured at Saffron Pharmaceuticals. • Perform vendor evaluation & qualification through vendor evaluation audits • Delivered trainings at plant for different motivational & technical topics.

• Worked as Trainee QC Analyst for 6 months in Saffron Pharmaceuticals (Pvt) Ltd. Faisalabad from February 2007 to July 2007. • Worked as QA Officer in Saffron Pharmaceuticals (Pvt) Ltd. Faisalabad from July 2007 to December 2008. • Worked as Senior QA Officer in Saffron Pharmaceuticals (Pvt) Ltd. Faisalabad from January 2009 to June 2010. • Currently working and In-charge Validation and Compliance in Saffron Pharmaceuticals (Pvt) Ltd. Faisalabad from July 2010 to date.

Analysis of Finished Products and Intermediate stages