Training & Compliance Specialist

Basel-Stadt  ‐ Vor Ort
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Schlagworte

Beschreibung

Reference Nr.: 8862TG

Industry:
Pharmaceuticals

Place of work: Basel

Start: ASAP

Duration: 6 months +

Introduction:

ITech Consult AG is a Swiss Recruitment Agency with profound experience in matching the needs of our clients with the perfectly suitable IT experts within various industries. Currently, we are looking for an experienced Training & Compliance Specialist for one of our clients in the Pharmaceutical industry.

Role:

Training Compliance

  • Work with Continuous Improvement & Training trainers and GCO managers to define applicabilities of mandatory processes and SOPs and related documents
  • Participate in training curriculum review and update
  • Track compliance with required training and other regulatory compliance (ie, code of conduct, SOPs, GCP, protocol training), manage feedback, provides updates to functional managers
  • Review training compliance reports prepared with Development Quality Training and support report improvement and accuracy
  • Participate in the design and organization of global training programmes

Process/SOP compliance

  • Ensure that a system is in place to track deviations from global SOPs in local sites, and oversee deviations in CPOs - ensure corrective actions are taken and followed-up
  • Provide assessment of GCO activities and documentation to assure compliance with Business, Legal and Regulatory Requirements through the review of records and systems at critical phases and recommend process and training improvements based on findings.
  • Support compliance and process improvement initiatives as needed.
  • Help coordinate input from other all groups in GCO

Process/SOP review and update

  • Coordinate SME input to SOP reviews and updates needed for periodic reviews or process changes
  • Maintain an overview of applicable SOPs and processes for all GCO roles

In partnership with CI&T functional excellence group, support the development of on-going quality assessments and self-inspections

  • Support implementation and tracking of related CAPA's and commitments.

Requirements:

  • BS and/or advanced degree in scientific discipline or life science background with at least 2-5 years relevant experience
  • Good knowledge of drug development/clinical trials processes. Good understanding of GCP requirements and quality systems
  • Analytical skills - detail orientation
  • Good written and verbal communication skills, ability to synthetize information
  • Team work in a multidisciplinary/global environment
  • Knowledge of Clinical/Pharmaceutical Quality Management Systems

Language: Fluent English (oral and written)

Start
22/10/2012
Dauer
6 months +
(Verlängerung möglich)
Von
ITech Consult
Eingestellt
23.10.2012
Projekt-ID:
438071
Vertragsart
Freiberuflich
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