Lead Quality organization across QA, QC, Quality Systems, and Regulatory functions to ensure production readiness for herbal pharmaceuticals.- Ensure QMS compliance with GMP and regulatory standards.- Monitor compliance with local, national, and international regulations.- Supervise supplier quality standards and logistics processes.- Identify and mitigate product quality and compliance risks.- Ensure staff training and continuous improvement in quality processes.- Act as primary contact for quality-related inquiries and regulatory inspections.- Contribute to the approval and purchasing of specialized production equipment designed for GACP and GMP processes.- Guide inspection readiness and support audit programs.

Played a role in preparing the company for production (CAR-T Therapy), focusing on training, documentation, and system implementation.- Responsible for the implementation and user training of a validated electronic record management system, encompassing logbooks and forms, for more than 700 final users.- Delivered comprehensive training programs to over 100 employees, covering technical writing, GMP documentation practices, and onboarding procedures.- Organized and conducted over 50 learning and knowledge sessions on topics such as good documentation practices, electronic documentation management systems, technical writing, and advanced word processing skills.- Prepared and organized practical templates for operational use, streamlining documentation processes.- Implemented computerized innovations within various departments to enhance efficiency and compliance.- Supported the development and maintenance of GMP-compliant documentation and record-keeping practices, ensuring adherence to regulatory standards.- Authored procedures and built systems for local documentation management, enhancing consistency and reliability.- Conducted risk analyses related to documentation management to identify potential issues and implement mitigating strategies.- Provided strong support for the global changeover from one document management system to another, ensuring a smooth transition at the local level.

Worked at Upstream Vaccine Launch Facility (COVID-19, RSV & Engineering runs)- Business System Owner for various process areas, including single-use technology bioreactors (up to 1000 liters) and clarification skids,- Responsible for validation and qualification of owned equipment, - Troubleshoot process equipment and facilitate involved SMEs to ensure production equipment is validated and well-maintained (periodic reviews),- Author and reviewer of SOPs, WIs, MBRs, and technical documents,- Preparation and training manufacturing operations in equipment, procedures, and changes, - Lead root cause investigations and preventive actions for complex deviations,- Participate in handling compliance records and defining, implementing, and executing CAPAs and corrections,- Initiate Change controls,- Expert in cell culture, bioreactors, and virus propagation,- Ensure GMP compliance and EHSS safety standards,- Project Lead and J&J global MTO award winner for leading a Lean Green Belt improvement to reduce leaks in a production facility,- Support lean projects.- Taking part in all activities related to the production of cGMP batches in the Vaccine Launch Facility,- Team management on the shop floor, deputy of supervisor. Team of 10-12 people, - Oversee the production area- First point of deviations escalation- Scheduling and training (TWI, Qualified Group trainer, TTT)- Actively setting up documentation for production purposes (SOPs, WI, MBR)- Involvement in deviation investigations and CAPA- Project Lead (Green Belt)- Interviewing new candidates- SME for several areas/devices- Scaling up and troubleshooting mammalian cell culture- Continuous Improvement Lead for several projects- Lead team-building sessions

Oh boy, my first job and what a journey it was! My time at Starbucks taught me the basics of management and customer service. It was a great experience, and I'm proud to have it as part of my professional journey.- Team management and team leadership for group of 15 people,- Building sales,- Analyzing sales,- Participating in complex store management, - Preparing new stores for launch, - Training for new shift supervisors.

- Work with aseptic standards;- Working in clean rooms with mice breeding;- Working with cancel mammalian cell cultures (A549, FaDu);- Working with CO2 incubators and in sterile conditions under laminar-flow hoods;