Riyadh Region
>Enthusiastic Quality Professional who is recognized leader in driving Quality Culture and motivate teams to be best in class. Clear goal vision and persistence in achievement by providing continuous improvement and problem solving attitudes. > A technical mind that excels when being challenged and possesses an entrepreneurial spirit along with a successful track record of ensuring the timeliness, quality and accuracy of a production & distribution processes. >Experience of working on the production including supply chain of a wide variety of manufactured goods and possesses a successful track of determining whether products meet expected standards. >Experience in Pharmaceutical industry includes following Non-sterile and sterile sections: ✓SDF's @ Tablets, Capsules ✓Dry powder suspensions ✓Injectable / Infusions / Sterile biosimilar & other generic solutions @ Ampoules, Vials Lyophilized, Cartridges, PFS, Vials Dry Powder, LVP, SVP & Eye Drops ✓Dialysis & Irrigation solutions ✓Medical Devices @ IV Sets ✓Semi-solids @ ointments & creams ✓Oral liquids @ solutions & suspensions Areas of expertise: - Change Controls, Deviations and CAPA’s. - Annual Product Quality Reviews (APQR’s). - Customer & Facility audits and compliance. - SOP writing, training and Implementation. - Documentation & Data control functions. - Site Master File, Site Validation Master Plan (PV, CV), Vendor Qualifications and Quality manuals. - Qualification of Utilities (HVAC, Process Air & Water) and major production equipements (DHTs, Autoclaves, SIP systems, Lyophilizers) - Technical quality agreements for customers and GMP providers. - Aseptic process simulations. - Tracking and trending of QO's, KPI's & QRM. - OOS, OOT investigations & root cause analysis (using various risk tools like FMEA, PHA, 5WHY, FISHBONE). - Thermal Validations / Mappings. - Investigation on incidents, Market complaints & recall management. - Managed & Supervised Shop floor activities. - Batch review & release functions. - URS, DQ, FAT, SAT, IQ, OQ and PQ for the facility & its critical equipments. - Hands on experience on E-systems including eQMS, eBMR, eAPQR, MINITAB, MS Word, Excel & Power Point, SAP, LIMS, QMS tools. - Handled US-FDA, JFDA, WHO, PIC/S, EDA, MOHAP, SFDA and DRAP audits for adherence with FDA 21 CFR 210, 211, 820 & WHO, PIC/S & EU GMP regulations, and ISO-9001/14001/45001/13485/17025 audits for standards system compliance. Reach me @ Call / Whatsapp +966 56 749 6906 Email: [email protected]
Overseeing QA activities for a new greenfield project focused on insulin localization. Responsible for supervising and coordinating various project-related functions, including qualification, validation, and compliance to ensure smooth execution and timely delivery. Lead quality initiatives, review and approve project documentation, and implement robust processes to maintain regulatory standards and best practices. Actively contribute to strategic planning, risk assessment, and continuous improvement to support successful project outcomes and strengthen organizational capabilities.
Responsible for leading and managing a greenfield project at Boston Oncology Arabia, focusing on the qualification of a new sterile biosimilar fill finish facility. Performed various QA validation roles, including planning and executing validation protocols, managed project activities, ensuring compliance with regulatory and cGMP requirements, including overseeing risk assessments and cross-functional collaboration resulting establishment of state-of-the-art sterile manufacturing facility.
My primary responsibility was to ensure that commercial products meet the highest quality standards and comply with regulatory requirements. In terms of commercial quality assurance functions, i played a crucial role in developing and implementing quality assurance strategies and procedures specific to the commercial aspects of Julphar operations. Which involved working closely with cross-functional teams, including production, supply chain, and sales, to establish robust quality control processes and standards. I was responsible for conducting comprehensive audits, inspections, and assessments of manufacturing processes, packaging, and labeling to identify any deviations or non-compliance issues. By meticulously analyzing data and reviewing documentation, i ensured that products meet the required quality specifications and adhered to relevant regulatory guidelines. Moreover, i was deeply involved in the validation and qualification processes at Julphar as being part of the core validation team responsible for sterile sites V&Q activities. By conducting thorough testing, verification, and documentation, we validated that systems are operating efficiently and consistently, meeting both internal and regulatory requirements. My role also involved overseeing change control processes related to commercial quality. That includes evaluating proposed changes, assessing potential risks, and ensuring appropriate documentation and approvals. I was also providing guidance and mentorship to the quality assurance team members, sharing my expertise and fostering a culture of continuous improvement. I was also collaborating with external stakeholders, such as regulatory bodies and customers, to address quality-related concerns and ensured compliance with contractual agreements. By leveraging my expertise and dedication, i was playing a pivotal role in maintaining Julphar's reputation as a provider of high-quality pharmaceutical products in the Middle East region.
Medipak Limited - the first integrated Infusion Solution and IV Administration Set manufacturing facility in Pakistan established with technical collaboration & know-how transfer from Fresenius AG, Germany. Decades-long collaborations have existed with leading multinationals such as Fresenius Kabi (Germany), Novartis (Switzerland), Laboratorio Pablo Cassara (Argentina), Mologic (UK), and other foreign partners. Non-sterile and sterile sections: ✓SDF's @ Tablets, Capsules ✓Injectable / Infusions / Sterile solutions @ Ampoules, LVP, SVP & Eye Drops ✓Dialysis & Irrigation solutions ✓Medical Devices @ IV Sets As a Group QA Manager i was responsible for overall QA functions of company both sites including: - Change Controls, Deviations and CAPA’s. - Annual Product Quality Reviews (APQR’s). - Customer & Facility audits and compliance. - SOP writing, training and Implementation. - Documentation & Data control functions. - Site Master File, Site Validation Master Plan (AMV, PV, CV), Vendor Qualifications and Quality manuals. - Technical quality agreements for customers and GMP providers. - Process & cleaning validation protocols and reports. - Aseptic Media fill/cleanroom validations. - Tracking and trending of QO's, KPI's, QRM and TQM. - OOS, OOT investigations & root cause analysis (using various risk tools like FMEA, PHA, 5WHY, FISHBONE). - Investigation on incidents, Market complaints & compliance reports. - Manage & Supervise Shop floor activities (IPQA). - BMR & BPR review & associated Batch release functions, Stability Protocol & Reports. - URS, DQ, FAT, SAT, IQ, OQ and PQ for the equipment’s, facility & its critical equipments qualifications. - Working on e-systems including eQMS, eBMR, eAPQR, MINITAB, Design Expert for QbD, Adobe Photoshop, MS Word, Excel & Power Point, Adobe, SAP, LIMS, KPI, QMS tools. - Handle DRAP audits for adherence with GMP regulations, and ISO-9001/14001/45001/17025 audits for standards system compliance.
As a freelance consultant, I have been entrusted with the responsibility of auditing multiple firms in accordance with ISO 9001, 14001, and 45001 standards. With expertise in conducting comprehensive system audits, I have assisted organizations in achieving and maintaining compliance with these internationally recognized quality, environmental, and occupational health and safety management systems.