Field Assurance Coordinator Resume
Contact information
Breano S. De Larzac
17 Street
Houston
Texas
Career objective
Looking for a challenging position of the Field Assurance Coordinator Resume the reputed University with a view to use my wide experience for the benefit of the organization.
I am a highly professional, competent and confident Coordinator/Administrator/PA with a good sense of humour. An organised and friendly team player, able to work under pressure with a positive 'can do' attitude. Experienced in communicating with people at all levels, often handling sensitive and confidential situations. Able to prioritise and multi-task, working efficiently and effectively on my own initiative. Excellent problem solving skills. Methodical and accurate. High degree of tact and diplomacy. Business aware.
Applications used: Microsoft Office [Outlook, Word, Excel, PowerPoint, Access Databases],
Pilgrim Global Complaints Handling System. Oracle.
SUMMARY OF CAREER HISTORY
Jan 2010 - Date Freelance/Contract Assignments.
BrotherMax Baby Products - Borehamwood.
Management reports. Research and collate product and customer reviews into effective spreadsheets for post market surveillance/key account/sales purposes. Customer surveys. Web based research.
Betty Barclay - Ladies Fashion - London.
Sales/Showroom Floor coordination. Organising efficient running of the Showroom during the selling season. Selling collections to customers.
Feb 1997 - Dec 2009 Regulatory Affairs/Quality Assurance Coordinator.
Smiths Medical International, Watford. Medical Devices.
Key Responsibilities:
Manage worldwide customer complaints ranging from product issues to investigating patient deaths. Dealing with a wide variety of people including Government Agencies, Healthcare professionals, Police, Coroners, sister companies, internal business managers and staff.
Manage and ensure effective completion of product recalls and field safety actions, liaising with customers, affiliates and regulatory bodies. Risk Assessments.
Develop and maintain excellent working relationships with regulatory authorities, i.e. FDA, MHRA, InterTek. Submission of incident reports to Government Agencies. Assist EU Representative.
Receive, document and respond effectively and tactfully to all complaints in a timely manner. Input and scan all information/documentation into Pilgrim Complaints Management Database. Coordinate technical investigations.
Analyse and review complaints, production and service records for regulatory compliance. Keep comprehensive and accurate complaint files. Identify and communicate opportunities for product/system improvements.
Trend analysis, management reports on product performance issues. Compilation of complaint history reviews, identification of key issues.
Participate in internal and external audits ensuring compliance with all standards, regulations and Smiths Medical Quality Management Systems SOP's/DP's.
Other roles held with Smiths Medical: PA to Technical Director/Operations Director, Manufacturing LogisticsCoordinator.
July 1995 - Jan 1997 Office Manager/PA to Managing Director.
City Print Buying Centre. Hackney. Print Broker/Stationery Supplier.
Multi-functional role ranging from HR duties to management accounts.
Manage effective and smooth day-to-day running of the office.
Key account management.
Secretarial and PA support for the Managing Director. Diary management.
June 1994 - June 1995 Exhibition Coordinator/PA to Exhibition & Event Director.
Phoenix Camden. Acton. Exhibition/Television/Film Furniture Hire.
Collating information from initial meetings with clients through to delivery/collection of exhibition/event furniture.
Project management. Logistics planning.
Close liaison with clients and all members of the team to ensure smooth running of exhibition/event furniture orders.
PA/Secretarial duties for Exhibition/Event Director.
March 1993 - June 1994 Business Partner/Administrator. Associates. Richmond. Media Planning/Buying.
Due to the rapid growth of this business owned by my husband, I took a short-term role within the company.
Bookkeeping, VAT returns, expenses, client meetings.
March 1987 - Feb 1993 General Office Manager/ PA to Chairman and Managing Director.
The Savile Row Shirt Company. London. Menswear/Fashion.
Private and confidential PA duties for the Chairman together with PA secretarial support for Managing Director.
Day to day running of the general office. Client meetings, collating collections
Close liaison with manufacturers/suppliers. Orders, contracts, deliveries.
Support to sales representatives. Coordination of exhibitions and sales conferences. Selling to key accounts from the London showroom.
Education: Sydenham County Girls School.
Qualifications: O' Level: English Language, English Literature, Maths, Biology, French.
Interests: Interior Design, Sewing, Egyptology, Forensic Science.
References: Upon request. Colleague/Manager personal recommendations available on
Public LinkedIn profile: http://uk.linkedin.com/pub/ /12/668/368
LINKEDIN RECOMMENDATIONS
- REGULATORY AFFAIRS/QUALITY ASSURANCECOORDINATOR
Smiths Medical
œWhilst I was RAQA Director at the infusion pump business of Smiths Medical, was a key individual in my RAQA Team. Her attention to detail and diligence in dealing with customers and their device reports in sometimes very difficult and challenging situations which could have involved serious patient injury was extremely professional, courteous and with considerable empathy whilst always mindful of the company's position and responsibility in respect of compliance with the regulations and any potential resulting liabilities. She has a very pleasant disposition and her personality helped considerably in the role she was performing and in her ability to network and form excellent working relationships with colleagues both inside and outside of the company eg MHRA, healthcare professionals. She is dependable and a very professional resource for any organisation. Sim, RAQA Director, Smiths Medicalmanaged indirectly at Smiths Medical
“As a co-worker, was a person I admired greatly. Her job put her directly in the firing line with dissatisfied customers, and her handling of these potentially difficult situations had a direct impact on the outcome of FDA audits. An unfavourable audit could have resulted in the company's entire output being embargoed, so her task came with constant stress.
Despite the considerable pressure thrived on the responsibility, remaining professional and unflappable, and acting as an anchor of calm. Her positive attitude, and her firm grasp of any awkward situation was an inspiration to all around her. She would be an outstanding asset to any potential employer.
Wright, Technical Author / Illustrator, Smiths Medical Internationalworked directly with at Smiths Medical
œI worked with for approx 6 years at Graseby / Smiths Medical. was extremely, efficient, professional and personable. I found her to be a very calm and worked well under pressure. She was committed and always responded to requests in a timely and effective manner. I believe to be a valuable team member, well organised and easy to work with. I would be happy to recommend for any future employment opportunities. Smith, Senior Product Manager, Smiths Medicalworked with at Smiths Medical
œ always displayed commitment and diligence in her work and was always focused on helping the businesses customers. She worked well in a team and was always supportive to other groups within the business.
Dyke, Product Support Manager, Smiths Medicalworked with at Smiths Medical
œ worked for me for two years and I could always depend on her to complete all the tasks that I gave her effectively and in a timely manner. I would recommend to anybody as she would be an effective member of any team.
Charters, QA Manager, Smiths Medicalmanaged at Smiths Medical
References
Breano S. De Larzac
Manager
Wap Company.
Breano_De Larzac@gmail.com
