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Quality & Regulatory Affairs Officer - Belgium  

Company managed [?] Still accepting applications
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Posted on : 04 August 2017

Project Description

 Description:
Our company is  a world leader in fertility and personal care is looking a reliable Quality and Regulatory Affairs Officer to assure consistent quality of production by developing and enforcing quality management system; validating processes; providing documentation; managing staff.


What you will do
  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
  • Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
  • Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
  • Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
  • Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
  • developing and writing clear arguments and explanations for new product licences and licence renewals;
  • preparing submissions of licence variations and renewals to strict deadlines
  • monitoring and setting timelines for licence variations and renewal approvals
  • writing clear, accessible product labels and patient information leaflets;
  • advising scientists and manufacturers on regulatory requirements;
  • providing strategic advice to senior management throughout the development of a new product
  • project managing teams of colleagues involved with the development of new products
  • undertaking and managing internal inspections and approved supplier/manufacturer audits
  • reviewing company practices and providing advice on changes to systems
  • liaising with, and making presentations to, regulatory authorities
  • negotiating with regulatory authorities for international marketing authorization

You should have
  • Experience as a quality assurance manager or relevant role
  • Thorough knowledge of methodologies of quality assurance and standards
  • Excellent numerical skills and understanding of data analysis/statistical methods
  • Outstanding communication skills
  • Great attention to detail and a results driven approach
  • Excellent organizational and leadership abilities
  • Proven history of being reliable and trustworthy
  • BSc/BA in business administration or relevant field
  • At ease with Quality Management Systems (ISO 9001, ISO 13485)
  • Fluent in English, and French.
  • Considerable understanding of both legal and scientific matters
  • The ability to work under pressure and to strict deadlines
  • The confidence to report to management
  • Strong negotiation and arbitration skills
  • Team-working skills and the ability to lead and motivate others
  • Networking skills and the ability to get on with a variety of people
  • Project-management skills
  • Integrity and a professional approach to work

Who we are
Our company  is a fast growing, financially stable multi-national pharmaceuticals company with personal development and growth opportunities extended to all employees. As well as being part of a great team that love what they do, you’ll enjoy a competitive salary package, Employment Contract of an indefinite period, hospitalization insurance, in a modern working environment.