Mohosin Kabir

Coordinated and managed examination activities for PharmD students, ensuring academic integrity and regulatory compliance, resulting in a 100% incident-free examination cycle.

• Successfully managed 100+ students during exams, ensuring smooth operations and compliance with exam procedures, resulting in a 100% incident-free examination process.

1. Maintained continuous improvement of the quality management system and Quality System within the R&D department, securing adherence to industry standards, regulations, and best practices. 2. Industriously oversaw formulation development activities in R&D, assuring strict adherence to project objectives, timelines, and quality standards. 3. Conducted self-inspections and review audits of R&D projects and facilities, identifying areas for improvement and cinching compliance with protocols, SOPs, and regulatory requirements 4. Evaluated and tended Change Control, Deviation, CAPA, and laboratory incidents, investigating root causes, implementing necessary corrective measures, and maintaining accurate documentation. 5. Prepared, reanalyzed, and updated Standard Operating Procedures (SOPs), guidance documents, the Quality Manual, and the Site Master File, guaranteeing clarity, accuracy, and alignment with regulatory guidelines. 6. Performed in-process quality control during pilot Biobatch production, carrying out careful sampling and testing at different stages to establish product quality, consistency, and compliance with approved specifications. 7. Led the requisition, receipt, storage, and dispensing of Reference Listed Drugs (RLD) for analysis, maintaining a well-structured inventory system and ensuring accurate documentation for traceability. 8. Commanded the issuance and monitoring of quality documents (like SOP, Form, and Logbook) and facilitated the archiving of R&D projects, insuring proper record-keeping, document version control, and easy retrieval for future reference or audits. 9. Coordinated and supported various departments such as IRA, QA, QC, Production, and PPIC, as well as collaborated with external agencies Like JAMP Canada, and BioCare Malaysia, providing necessary documentation and support for their requirements.

1. Implemented Quality System in R&D. Closely monitored formulation development activity in R&D. 2. Self-inspection and auditing of R&D projects and R&D facilities. 3. Evaluate Change control, Deviation, CAPA, and Laboratory incidence. 4. Prepare and review of SOPs, Guidances, the Quality Manual, and the Site Master File. 5. Performed in-process quality control during pilot Biobatch production. 6. Sampled different steps of Biobatch production, Method development, and Validation sample. 7. Manage RLD (Requisition, received store, and dispense for Analysis) 8. Issued and control of Quality documents and archiving of R&D projects. 9. Conducted Quality Review Meeting. Coordinating training programs 10. Supported different departments like IRA, QA, QC, Production, PPIC, and agency for the necessary documents

1. Actively sampled bulk, intermediate, and finished products to perform comprehensive quality control (QC) analyses. 2. Managed all aspects of the document, including issuance, retrieval, disposal, and archival, certifying efficient and systematic documentation practices such as SOPs, STPs, Specifications, Master lists, and Vendor lists. 3. Carried on thorough evaluations and assessments of CCF, Deviation, OOS, and CAPA, promptly reporting any discrepancies. 4. Directed the issuance and authority of batch documents and log books, promising accurate record-keeping, and arranged the monthly SOP training sessions. 5. Regulated painstaking inspections and approved finished products for release and distribution. 6. Compiled, summarized, and thoroughly archived batch history records for future reference and compliance purposes. 7. Prepared, reformed, and updated SOPs and Certificates of Analysis (COA) for export products. 8. Led the establishment of all aspects of Annual Product Quality Reviews (APQR), including comprehensive long-term stability testing, and effectively handled market complaints. 9. Assumed responsibility for the storage and appropriate disposal of retention samples from every batch in accordance with applicable regulations and internal quality compliance protocols. 10. Provided assistance during external agency audits and regulatory audits, Committing compliance through precise preparation, facilitation, and issue resolution.

1. Actively governed and supervised the manufacturing and packaging activities for tablets, capsules, PFS, and sachets to ensure adherence to the quality process, maintaining accurate inventory records, and minimizing wastage. 2. Efficiently dispensed raw materials and coating materials required for the manufacturing 3. Demonstrated effective leadership by supervising and providing guidance to operators, helpers, and other production workers, fostering teamwork, and promoting a safe working environment. 4. Flexibly adapted to both routine and non-routine production demands, efficiently coordinating resources and Effective planning to meet fluctuating market requirements. 5. Practiced vigilant Observation of production output, consistently achieving a low rejection rate and foresighted addressing any issues that may arise through effective analytical techniques. 6. Performed vigorously in-process checks on manufactured products, and contributed to the overall quality efforts of the production process.

Coursework topics include Industrial Pharmacy I & II, Advance Biopharmaceutics and Pharmacokinetics, Advance Physical Pharmacy I & II, QBD and Process Validation, Biostatistics and Pharmaceutical Regulatory Overview

1. Drug Development and FDA Meetings 2. Applicability of FDA Drug Regulations to Clinical Studies 3. IND Content, Format, Review and Maintenance 4. Medical Device Development and FDA Meetings 5. Applicability of FDA Device Regulations to Clinical Studies 6. IDE Preparation, Submission, and Maintenance

Coursework topics include: Pharmaceutics, Pharmacology, Drug Design and Delivery, Analytical Chemistry, Clinical Pharmacy, Molecular Biology and Bioinformatics, Drugs Use Management and Toxicology