Quality Assurance Specialist - English Fluent- Permanent contract (100%)

18.02.2020 | Employee | 100%



For our partner, an international company specialised in the development,
registration and worldwide commercialization of pharmaceutical
and healthcare products KELLY SCIENTIFIC is looking for a

-...

Quality Assurance Specialist - English Fluent- Permanent contract (100%)



For our partner, an international company specialised in the development,
registration and worldwide commercialization of pharmaceutical
and healthcare products KELLY SCIENTIFIC is looking for a

Quality Assurance Specialist - English Fluent
Permanent contract (100%)

JOB POSITION

  • The Quality Assurance Specialist is in charge of the quality-related aspects of the products during distribution. This responsibility starts with the process validation phase and lasts along the product life-cycle.
  • The Quality Assurance Specialist is responsible to ensure that all the products' quality related matters are managed according to established procedures.
  • The Quality Assurance Specialist works in close collaboration with internal and external resources and reports to the Head of Quality Assurance.
  • A real partnership exists with the other departments (e.g. supply chain, development, regulatory affairs). External contacts include the clients of company (affiliates, distributors and customers) and the external third-parties such as contract manufacturers, external laboratories and distribution centers.
RESPONSIBILITIES
  • Be involved in process validation
  • Prepare and coordinate product launches
  • Review and approve batch documentation records and related GMP documents,
  • Ensure quality oversight of the day-to-day operations at contract manufacturers and distribution centers as per GMP and GDP guidelines,
  • Follow all quality processes according to established procedures such as change controls, deviations, complaints, investigations, CAPA plan,
  • Follow and review stability studies and Product Quality Review from contract manufacturers
  • Participate to the qualification of suppliers and subcontractors, including performance of external audits
  • Implement Quality Agreements with the clients of Company
  • Support alert and batch recall process
  • Support the implementation and maintenance of Company quality systems, including the preparation of quality management reviews and audits (inspections and internal audits).
EDUCATION / WORK EXPERIENCE
  • Pharmacist or equivalent scientific degree
  • About 5 years of experience in Quality Assurance in a pharmaceutical industry
  • Previous experience working in close collaboration with subcontractors
  • Previous experience working in medical devices industry an asset
QUALIFICATIONS
  • Knowledge of applicable European and national regulations
  • Knowledge of GDP/GMP regulations
  • Fluent in English
  • Well-organized and detail-oriented
  • Strong analytical skills and ability to take decisions
  • Independent with good teamwork and communication skills
  • Keen on working in an international environment
  • Able to travel (up to 15%)

18.02.2020
Employee, 100%

Contact

Kelly Scientific Genève

Amina Oumeziane

Rue du Rhône 114

1204 Genève

Phone: +41 22 737 12 00

Fax: +41227371213


Kelly Scientific Resources

rue du Rhône 114Geneve

Industry

Human resources / Personnel services

Kelly Scientific Resources

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
Salary

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