Cristina Vilciu
Limerick,LK
Summary
Experienced in GMP manufacturing environment in medical device industry Experienced with ERP System Access Supply Chain, MieTrak and JBase Experienced in booking in stock and kitting work orders Experienced in final inspection of products. Enjoys working in a busy team environment and working on own initiative. Willing to engage in further learning and training. Available to work flexible hours, under minimum supervision, as required including evening and weekend nights. Target oriented.
Overview
20
20
years of professional experience
Work History
Manufacturing Team Member in Plastic Stents (CMA)
Cook Ireland Limited
06.2021 - 04.2025
- Company Overview: Medical Devices
- Working in a GMP controlled manufacturing area – evening shift
- Currently working in the packaging area, continuous flow line, responsible for packaging, labelling and logout of products including line clearance.
- Responsible for manufacturing products according to quality standards, set targets and GMP requirements.
- Experienced in multiple product building and assembly of medical device products, self-assessment of work including visual inspection using the magnifier.
- Ensuring that products comply with established specifications.
- Assembling positioners using the heat gun and wire guides.
- Completing results of products assembled to ensure traceability.
- Operating the tip forming machine for nasal tubes and the flaring machine.
- Trainer for new starts on the machines.
- Trained in logout in Urology area.
- Kitting work orders for production, including issuing materials on requisition forms and kitting for packaging (including printing product labels and caution labels).
- Following all procedures and ensuring all product and process is following Quality Systems requirements.
- Medical Devices
General Operative and Final Inspector in Waste Water Project and Stores Assistant in Finished Goods Stores
Ohshima Ireland Limited
01.2019 - 05.2021
- Company Overview: Aerospace Industry
- Finished Goods Stores (including CP and WIP stores):
- Booking in stock, kitting work orders in CP (Component Parts) and WIP (Work in Progress) stores using computer database (Access Supply Chain - including the barcode scanner and MieTrak).
- Booking in stock, issue and book in, adjusting lots, stock adjusting, stock status, locating stock, lot history using Access Supply Chain.
- Sales allocations, allocate stock, preparing Pick Notes, reprinting stock labels, picking, confirm pick notes, reversing pick notes using Access Supply Chain.
- SMI (Supplier Management Inventory): allocate stock, transfer stock, generate packing lists and commercial invoices, receiving pick list and processing SMI pick notes using Access Supply Chain.
- Waste Water Project:
- Faucets, selector valves and shut-off valves assembly, all operations performed in a GMP Manufacturing Environment (Clean Room).
- Team member on project to improve Work Instructions for assembly and Process Flow with Quality and Engineering.
- Support on Nonconformance process. Troubleshoot defective products returned by customer to determine root cause of failure.
- Conducting Final Quality Inspection for each assembly shipped to Client – highly cosmetic parts. Completing records of inspection results, acceptance, rejection and disposition.
- Final Quality Inspector for all parts and piece parts used in sub assembly and final assembly.
- Issue all parts and piece parts using MieTrak.
- Achievements:
- No rejects from the Client for six months in a row.
- Our project was renewed by the Client with substantial increase of orders after successfully competing with several other suppliers.
- Aerospace Industry
PSC Group Administrator
PSC Biotech Limited
08.2016 - 03.2018
- Company Overview: Life Sciences Consultancy
- Recruitment/Administration Assistant (Limerick - remote) [Sept 2016 – Aug 2017]
- Administration to Managing Director including filing, scanning, composing correspondences, data entry, making travel arrangements/event organisation as per request.
- Read and understand technical documentation.
- Assisting with RFPs and meeting submission deadlines.
- Candidate sourcing, candidate screening, job advertising.
- Recruitment Administration including organising files using Dropbox, ensuring employee files are up to date and audit ready.
- Assist with new employee mobilization to Ireland when required.
- Support the Senior Recruiter with ad-hoc recruitment activities.
- Setting up meetings for the Managing Director using Webex and Outlook, support the Managing Director with ad-hoc administration activities.
- Life Sciences Consultancy
Administrator
Pharma Serv International SRL
01.2012 - 12.2016
- Company Overview: Research and development in biotechnology
- Representing the company in relations with third parties and with Authorities.
- Confidentiality of data, information and documents.
- Archive responsible for the GLP archive and implement and maintain the archive:
- Archive completed study raw data, protocol, reports, equipment logs and electronic data/records following the appropriate filing system based on current SOPs.
- Ensure that the laboratory personnel follow archive Standard Operating Procedures (SOPs) to be in GLP compliance.
- Write and revise SOPs for archive procedures.
- Organising and maintain archive documents.
- Carrying out the company activity in compliance with the Law and with the implementation of Law.
- Internal regulations and work instructions developed by the company management are followed.
- Internal Rules of Procedure and the Rules of Organization and Operation of the company are followed.
- Attending to internal and external trainings organized by the company.
- Business travels (e.g., travels to the headquarters in Germany).
- Research and development in biotechnology
Assistant to Manager
3S Clinical & Laboratory Research SRL
01.2005 - 12.2012
- Company Overview: Activities Concerning Human Health
- Telephone connections, sending and receiving faxes, receiving and distributing correspondence.
- Documents typing, protocol activities, ordering and controlling office supplies.
- Drawing up invoices, payment orders.
- Ordering laboratory consumables: compounds, tubes, chromatographic columns, pipettes, syringes, needles, autosampler plates, sealing mats.
- Co-operation with internal and external customers and collaborators.
- Activities Concerning Human Health
Education
Payroll Skills - QQI Level 5
Pery Square Business College
01.2019
Bachelor’s Degree - Technical Geology
The University of Bucharest
01.2003
High School Diploma -
Nicolae Kreţulescu Secondary School
01.1995
Skills
- Attention to detail
- Strong problem solving skills
- Positive attitude
- Dedicated
- Result driven
- Team member
- Enthusiastic
- Productive worker
- Initiative
- Effort
- Exceptional listener
- Effective communication
- Verbal communication
- Written communication
- Highly organized
- Professionalism
Languages
English
In House Training
- Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) training
- Access Supply Chain and MieTrak training
- JBase training
- Final Inspector course
- Manual Handling training
- Documentation procedures: developing SOPs, internal trainings
- Records Archiving documents – training and procedures
Timeline
Manufacturing Team Member in Plastic Stents (CMA)
Cook Ireland Limited
06.2021 - 04.2025
General Operative and Final Inspector in Waste Water Project and Stores Assistant in Finished Goods Stores
Ohshima Ireland Limited
01.2019 - 05.2021
PSC Group Administrator
PSC Biotech Limited
08.2016 - 03.2018
Administrator
Pharma Serv International SRL
01.2012 - 12.2016
Assistant to Manager
3S Clinical & Laboratory Research SRL
01.2005 - 12.2012
Bachelor’s Degree - Technical Geology
The University of Bucharest
High School Diploma -
Nicolae Kreţulescu Secondary School
Payroll Skills - QQI Level 5
Pery Square Business College
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