Shahabuddin Ahmed

Insightful QA & RA Associate with a solid background in GMP and ISO 9001. Demonstrates a strong commitment to ensuring compliance and an unwavering drive to acquire new knowledge for driving positive changes in Quality. Dedicated to pursuing continuous self-improvement. Ambitious, consistent, and efficient in approach.

• Quality Assurance & Regulatory Affairs Associate, Astrea Bioseparations, 09/22, Present, Cambridge, Creating, updating and monitoring Regulatory Support Files, steering production towards a fully Quality compliant approach, adhering to ISO 9001:2015, 21 CFR 177, USP Class VI and BPOG regulations/guidelines, researching, updating and implementing new procedures inline with current regulations, training company staff on Quality awareness, visiting manufacturing sites to perform internal audits and creating action plans, completing projects within challenging deadlines, working collaboratively with other departments to achieve common goals, upholding departmental and interdepartmental relations, adapting and prioritising demanding tasks interchangeably according to volatile circumstances, admin user and trainer of company EQMS, handling of change controls, deviations and CAPAs, ensuring company licence approval of controlled substances, performing risk assessments and GAP analysis, liaising with external suppliers and customers for compliance purposes, reviewing and approving technical reports and batch manufacturing records, implementing changes following findings due to audits, performing root cause analysis, managing and meeting company expectations, achieving targets and key performance indicators, Designed, Developed and Implemented a training and tracker system where there was none previously, Achieved 95% of product SDS documents to current regulatory compliance, Spearheaded RSF projects for 4 major products
• Quality Assurance Officer, L M Manufacturing Limited, 06/19, 09/22, Weedon Bec, Coordinating the QP release of commercial products, preparing, reviewing and approving Quality documents including SOPs, conducting internal audits, fulfilling roles during external audits, issuing, reviewing and tracking batch cards, training coordinator, performing new product assessments, rejection of raw materials for destruction, handling QMS documents, managing archival of documents, assessing and writing reports on temperature monitoring of critical materials during transport, management of vendors, maintaining full traceability of documents, Coordinated 70% of commercial batches for market release, Slashed backlog of batch card reviews by 60%, Restructured GMP activities on site for improved compliance via updating of SOPs and trained briefings
• Counter and Dispensing Assistant, Tesco Pharmacy, 11/14, 06/20, Weston Favell, Reporting to Responsible Pharmacist and Pharmacy Manager, customer service and satisfaction, patient counselling, safety and cleanliness of work environment and maximising clinical safety of medicines for dispensing, handling, management and accounting of Controlled Drugs