Lenka F. Email & Phone Number

Penang, Malaysia

• Preparing next generation of Tool install commissioning engineers for their roles in a newly built Fab. This is a knowledge transfer assignment to ensure the team of 6 local engineers is prepared to support the tool.
• Communicate EHS installation requirements and provide ESO programme guidance to the Tool Owner and IQ Team.
• Manage ESO ramp up in assigned functional areas.
• Participate in ESO/facilities sign offs as required.
• Demonstrate knowledge of the ESO BKM’s and Corporate guidelines.
• Provide ESO, EHS Design and Tool De-install training as required.

Leixlip, County Kildare, Ireland

• Equipment Sign off Engineer’s duties evolve around creating a safety communication channel between construction trades and the Tool Install department of Intel.
• Assisting with the development of Tool specific ESO Install and Tool De-install checklists.
• Participating in Hazardous energies control process as part of the Safety level 1, 2 & 3 sign offs by the EHS.
• Ensuring applicable codes, standards, and Intel EHS requirements are integrated into design, installation, start-up and qualification of all process Tools.
• Supporting IQ/facilities incident investigations and assisting with the implementation of the incident and injury free (IIF) program.
• Supporting design review for assigned Tools with the various tool owners

Dun Laoghaire, Leinster, Ireland

• Supervised the manufacture of moulded diabetic care product and participated in internal systems audits
• Drove root cause analysis of non-conformances by providing non-biased fact based data
• Liaised with relevant personnel regarding flow of product from moulding the individual components to terminal sterilisation
• Maintained cGMP practices across all operational departments under quality responsibility (Incoming material, moulding, assembly, packaging, sterilization and warehouse)
• Released batches in SAP and KONNEXIS upon completion of final release testing
• Dealth with material supply and vendor issues during root cause investigations

IDA Industrial Park, Southern Cross Road, Bray, County Wicklow, Ireland

• Reviewed the effectiveness of existing test methods and worked on quality issues rising from production areas
• Supported supply chain by carrying investigation studies targeted to adjust acceptance criteria for raw material incoming inspection based on statistical analysis
• Worked with relevant departments on timely closure of an OOS events and Deviations to ensurecontinuous Quality control and manufacture.
• Defined sampling plans using ANSI tables according to ISO 13485 and reviewed data to support material disposition
• Assisted in regulatory audits
• Approved and managed change control (CR) requests using quality management software similar to Trackwise

Dublin - Sandyford

• Site visits to manufacturing partners in UK to ensure high quality level of manufactured reagents, with focus to maintain procedures to ensure that the device design, its components and configuration, is correctly.
• Reviewing manufacturing records post manufacture to ensure compliance.
• Establishing and reviewing test methods and adjusting acceptance criteria of existing products based on the statistical analysis.
• Controlling stock and non-stock material including equipment for QC and production plannin using SAGE software.
• Liaising with suppliers to investigate quality issues on raw materials and executing the testing of received material.
• Compiling historical product performance analysis.

Dublin - Bray

• Worked as a part of hemostasis group on product release and quality control of manufactured products and incoming raw material.
• Liaised with planning and manufacturing to coordinate production schedules.
• Completed testing protocols for other departments to ensure smooth supply and improvement of existing (on market) products.
• Executed timely OOS (Out Of Spec) investigations to ensure effective root cause analysis and risk mitigation for future.
• Exercised strong problem-solving abilities, troubleshooting any non-compliances with samples and equipment to close out Lab Investigation Reports and to find root cause.
• Analysed data generated using validated Excel spreadsheet or unvalidated Minitab verified spreadsheets.

Bray, Southern Cross Road, Co. Wicklow

• Worked as a part of cross functional team on application development and validation of in vitro diagnosis (IVD) instruments that were designed to study and monitor haemostatic blood disorders in patients
• Used the knowledge in biochemistry to understand the pathophysiology of our clotting tests and the role of various products and reagents produced by Tcoag and STAGO
• Provided scientific assistance for the testing, maintenance and calibration of Tcoag/STAGO instruments
• Planned and executed validation scientific studies such as carry-over testing, precision, linearity, sensitivity, interference and normal reference interval based on demo- graphical location, to support product release.
• Planned testing including resource management and material ordering.
• Verified spreadsheets using appropriate SOP's using Excel and Minitab.

Bray, Ireland

Dublin, Ireland

• Dispensed drugs to patients following prescribers instructions, assisted the pharmacist
• Received deliveries and placed orders to ensure quality stock control and stock rotation
• Assisted in monthly paperwork submission and credit claiming
• Dealt with patient queries over HSE provided schemes such as DPS expenditure form
• Provided basic medical services e.g. healthy heart check, maternity TENA service, hosiery and stop smoking service
• All activities mentioned above involved working in a multicultural team and the delivery of excellent customer service.

London, United Kingdom

• Assisted in the daily running of the pharmacy and served patients at the healthcare counter
• Controlled the stock levels, ordered and received deliveries, priced stock and kept displays presentable and clean, direct dealing with sales representives
• Distributed a range of promotional material on behalf of the proprietor
• Maintained register of private prescriptions for NHS inspections, helped the proprietor with entries of invoices
• Supervised multinational team of 6 to the best of my abilities
• Recruited new staff and evaluated their performance of regular basis

Bachelor Of Science (Hons.), Medicinal Chemistry And Chemical Biology, Gpa 3.88

Activities and Societies: RSC Chemistry Society, German SocietyMolecular Basis of Disease Pharmacology Industrial Microbiology Project.

Pgdip, Medical Device Technology And Business, Merit

The course focuses on core competencies such as medical device classification, device design cycle, manufacturing, quality systems &.

Biotechnology Processing

Activities and Societies: Manipulation with mammalian cellsOn the job training course comprised of: DAY ONE: Mammalian cells were.

Certificate, Environmental Health And Safety

Safety, Health and Welfare at Work Act 2005 and the General Application Regulations 2007, Fire hazard, Risk management, Accident.

Internal Auditing Course & Mdsap Regulatory Course, Regulatory Affairs

MDSAP Medical Device Single Audit Program regions – US, Brazil, Australia & Japan

Project Management, Pmp Certification

Activities and Societies: PMICourse designed to elevate project management skills and prepare candidates for success on the PMP exam.