Parenteral & Liquid Products Technical Specialist (Technology Transfer Project Manager)
- MaintenantServices à la personne As a steriles project manager, coordinated closely with production, supply chain, logistics, analytical development and quality control for successful planning of pilot/trial and validation batch activities.
As a steriles technical specialist and project manager, planned and assisted with conversion, optimization, formulation manufacturing and technical troubleshooting and analytical method transfer/validation and trouble shooting of existing and new product ranges of sterile projects (including biological injectable products) and ophthalmic preparations at different stages in the sterile manufacturing pathway and product life-cycle.
As a steriles project manager, planned and successfully executed several exhibit batches and complete sterile process validation exercises for several technology transfers projects.
Implementation of sterile projects in the factory by evaluating product and process feasibility on the available sterile platform through evaluation of submission documentation and product dossiers and assessing the suitability for its transfer into the receiving site.
Identification of risks involved during the course of entire technology transfer process, drawing up formal risk assessment and developing appropriate risk mitigation strategies through implementation of QRM tools, wherever applicable.
As a steriles projects technology transfer projects manager and department team lead, prepared, drafted and finalized departmental SOPs for sterile tech transfer projects.
Setting up the validation master plan, validation matrix, risk assessment and identification of worst case conditions in consultation with site validation department with due consideration to cGMP validations requirements for sterile projects such as, but not limited to, filter validation, hold time study, media fill validations, cleaning validation and transport validation including container-closure integrity assessments.
Analyzing process capability (Cpk) and process performance capability (Ppk) during sterile filling operation using statistical tools depending on machine capability.
Provide detailed assessment of primary packing components, prepare, plan and execute stability protocols including leachables study on the finished product.
As a formulation research scientist established quality target product profile (QTPP) by identifying critical processing parameters through CMC and CQA review of dossier and cognitively prepared design space by implementation of quality by design (QbD) principles during early phase development.
Review of batch manufacturing instruction and preparation of project plan.
Well aware of current regulatory guidelines and substantially experienced in the preparation of documents related to common technical document (CTD) and other dossier related documents which were used in actual submissions.
Actively involved during site inspection by German Regulatory (BfArM) and experienced in responding to regulatory queries (RTQs) from various Ministry of Health (MoH) post submission.
Exposure to project planning tools such as Microsoft Project and statistical data research tools such as Minitab.
Successfully completed international technology transfer of sterile projects with invaluable site visit to GSK facility in France, on July 2014. The site now owned by Aspen.