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Quality & Regulatory Affairs Officer - Belgium  

Sasmar (company)


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.

Locations

Chaussée de la Hulpe 187 1170 Brussels Belgium

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