Anna Beletsky Email & Phone Number

Edinburgh, Gb

Edinburgh, Gb

Edinburgh City, Scotland, United Kingdom

•Working as part of a team that provides a 4-week introductory programme to new starts.•Train out the principles of GMP, EudraLex’s rules and regulations.•Summarised and explained key steps in the cell and gene therapy manufacturing process•Carried out in person training on how to operate various cleanroom equipment.•Trained employees how to use systems such as QMS and Pharmagraph•Updated and managed the 4-week programme. •Ensuring efficient and accurate scheduling of sessions to meet the weekly outcomes.•Created a document for new starts which eased the tracking of training sessions completed.•Created a checklist for the training team to track progress.•Achieved a trainer status in many critical manufacturing tasks such as Batch record review•Developed training efficiency checks for the training team.•Developed weekly training efficiency checks to track the new starts overall progress of the 4-week programme.•Developed feedback forms for the 4-week programme to help streamline training. •Trained and demonstrating gowning for the FDA inspectors.•Developed a 2hr presentation/practical GDP training session alongside my co-worker.•Rolled out the 2hr GMP session to multiple departments.•Supported regular training updates to reflect changes in SOPs.•Supervised weekly operator aseptic qualifications (OAQs).•Responsible person for reviewing OAQ batch records and addressing any further comments by QA. •Regularly assessed and graded operators and assistant operators aseptic techniques in the Grade B cleanroom. •Supervised Aseptic Process in Grade B.•Scheduled and maintained monthly refresher sessions and assigned them to team members. •Responsible for training a new member of the Training Team.•Supported the roll out of grade A first air principles to the manufacturing department.•Kept on top of daily admin tasks such as cleaning training labs, laundry, waste, responding to training queries and sorting of incoming materials.

County Limerick, Ireland

•Shift work, 12hrs, days and nights.•Working within an ISO7 cleanroom environment.•Working with mammalian CHO cells for the production of monoclonal antibodies.•Supporting my team and the wider process area to meet deadlines.•Supporting process related activities.•Maintenance of equipment. SIP’s / CIP’s•Filling out and reviewing GMP documentation, batch records and batch related data.•Working to complete various time critical batch related deadlines daily. •Troubleshooting and problem solving when issues arise, escalating to management. •Carrying out risk assessments. •Carrying out material and quantity checks.•Sampling of batches and ensuring specifications and trends are met.•Supporting the manufacture of two different pharmaceutical product lines simultaneously, avoiding cross contamination.•Flexibility in supporting teams in other process areas when help is required.•Experience in validating and testing a new manufacturing process for a new product.•Collaboration with QC, QA, QA Validation, MSAT and Process Sciences departments.•Reviewing documentation and tasks completed by my team members and the shift prior to ensure everything has been completed correctly.•Training new staff

Cork, Ireland

Summary: Supporting QA Specialist and QA Team. Responsibility for carrying out tasks pertaining to compliance and quality. Partnering with QC department to ensure that QC systems are maintained in a compliant manner. General Responsibilities: Adhered to site policies/procedures, cGMP and environmental health and safety regulations. Executed responsibilities in line with Right First Time principles. Supported Continuous Improvement projects within QA. Specific areas of responsibility: • Completion of training program (core and task specific procedures) • Completion of training on electronic systems e.g. PDOCS, QTS • Updating GMP site procedures • Completed Method 1 training • Working with Data Integrity team to streamline the process for the Control and Reconciliation of GMP documentation. • Working with QO systems team to complete Equipment Periodic Reviews. • Actively participated in Site Inspection Readiness team for Corporate Inspection. o Completed QA audit readiness tasks e.g. Updating SQRT schedule, verifying schedule adherence, archive room filing, maintenance of Quality Agreements. o Completed GMP walkthroughs of production and QC areas. o Completed documentation for job function curricula periodic reviews. o Identified as a runner (providing documents to audit escorts as per auditor requests) for corporate inspection • Attended key meetings. o Site Quality Review Team (SQRT), Daily QA scheduling meeting, Audit readiness meeting, Quality Metrics reviews, Site investigation review meeting. • Actively participated in site “Safety Quality Commitment program (SQC)”. o Attended workshops and meetings during SQC week. o Demonstrated commitment to safety by raising SIMS reports on safety issues and participating in quality-related conversations.

Limerick, Ireland

• Managed customer appointments using computerized software. • Worked independently • Interacted with customers • Offered advice on products instore • Ensured customer satisfaction • Dealt with complaints and customer enquiries • Handled customer payments cash/card • Cashed up tills upon closing every night. • Cleaned and tidied the salon at the end of the day • In charge of locking up and setting the alarm • Trained new employees • Received health and safety training.

(Mscr) Masters Of Research, Regenerative Medicine And Tissue Repair, 2:1

Research project Masters based at the school of Veterinary and Medicine at the University of Edinburgh, Clinical Sciences division. Study.

Bsc, Biotechnology, 2:1

Higher Certificate, Third Level