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Job Details

Manager, Quality Assurance (Frankfurt)

Company: LINICAL Spain
Location:
Reference: QAFRA
Closing Date: 01 Sep 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Requirements:

  1. Support the head of Quality Assurance department in maintaining Linical's quality management system for all Linical services including
  2. Conduct of audits
  3. Create risk-based audit plans
  4. Follow up of corrective and preventive actions (CAPA)
  5. Supervision of SOP revisions
  6. Review of SOPs in co-operation with the operational staff to ensure compliance with GCP and regulatory requirements
  7. SOP-management (access, notification, tracking of SOP, filing of originals, etc.)
  8. Improving of standards and processes for quality and efficiency
  9. Vendor qualification
  10. Provide support prior and during regulatory inspections by authorities and audits performed by sponsors on Linical.
  11. Consultancy for operational staff in quality, procedural and regulatory related questions
  12. Administrative tasks related to the maintenance of the quality management system and training system of Linical Europe.

Qualification:

Essential Qualification

  1. At least 5 years of experience in clinical research according to GCP thereof at least 2 year in a quality assurance related role within the GCP environment.
  2. Very good knowledge of GCP principles and related European and national regulations and regulatory requirements for the conduct of clinical trials.
  3. Practical experience of auditing and SOP management
  4. Preferable Qualification
  5. Participation in seminars for auditing or quality management
  6. Quality Management or Auditing certificates 
  7. Essential Skills:
  8. Excellent command of written and spoken English
  9. Used to work accurately and independently
  10. Advisory skills
  11. Ability to familiarize oneself with specific indications, symptoms and study designs
  12. Very good knowledge of standard office software

Preferable Education:

  1. University/college degree or equivalent in  medical or other life-science fields

Apply for this job: Manager, Quality Assurance (Frankfurt)

Contact Information:

Address:  Head Office
c/ Rosa de Lima, 1-bis, Edificio Alba Las Matas, Madrid
28290
Spain
Tel:  +34 91 372 60 00
Fax:  +34 91 372 60 60

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