Abdul Sattar Email and Phone Number

Responsible for achieving quality and cGMP standards, regulatory compliance during the pharmaceutical liquid and solid dose production process. Continuous improvement, quality management and manufacturing, Support the quality system for research, training compliance and development, Update SOP/Training to implement each process. Monitor production for compliance to customer specifications, GMP, pharmaceutical standards and internal SOP’s. Performs in-process and final inspections as well as Line Clearances and production line challenges. Perform the internal audit and inspection. Review and approval of protocols related to AQLs, inspection, GS1 2D coding, serialization, rework, reprocessing, repackaging and other activities. Review and approve Raw Materials, Packaging Components and Finished Product Specifications. Quality Metrics related to right-the-first-time. Write and update process validation/qualification protocols and reports. Issue components, review log books, batch report, and reconcile batch reports, participate in pre-production planning audits and validation activities, performs quality tests, conduct sampling routines, documents findings, track trends. Review reports, records and data for completeness and accuracy as well as to confirm their compliance with internal procedures and US, FDA and Health Canada regulations. Accountable for ensuring the appropriate quality oversight and performance evaluation.

• An accomplished Pharmaceutical Quality Assurance Professional with significant background in Pharmaceuticals GMP operations. Pharmaceutical Quality System (PQS), Skilled in Good manufacturing practices (GMP), Aseptic processing, Corrective and Preventive Action (CAPA), RISK Analysis, Deviation Investigation, Writing, developing and validating protocols, SOP and HIPPO applications.Experience with FDA and Health CANADA inspection and other quality audit for facilities and process.Other skills: Complaints Investigations, OOS/OOE/OVR/MVR investigations, QMS, Risk assessment, Quality agreement, QBD, Regulatory Inspection, ICH9 - ICH11 assessments, OH & S Act.

• Worked on very fast primary and secondary Pharmaceutical products Packaging line, follow SOP, Q/A, Q/C, Complete the GMP and cGMP documents and machines for packaging, filling and IPT on regular basis

• Excellent experience of PHARMACEUTICAL products packaging, GMP regulations, SOPs, SAP,TMP, SIX SIGMA and FREEWEIGH, very good knowledge of FDA, HBP, EMEA, and good experience of current operating systems like ANGILE and SAP data, safety regulations Line Inspection and Productions in a field like chemical, pharmaceutical and Development labs, quality and Research Lab.

Teaching, Assisting professor, performing synthetic organic chemistry research programs for PhD program.

Assembling, Testing and Packaging

Done some Enhance Oil recovery projects and publish 6 articles in different international journals