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Job Details

Clinical Quality Assurance Manager

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895670 -P
Closing Date: 23 Mar 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

•Plan, conduct or subcontract, and report audits of processes, systems, projects and/or sites within budget and established timelines based on approved schedule. •Prepare, review Audit reports and CAPAs issued by internal and external providers including assessment and follow up with individuals until closure of any CAPA

Requirements:

Reference Number:       895670 -P

Type of placement:      Contract 12+ months (High chances of an extension)

Location:                      Switzerland, Basel

Main Responsibilities

  • Plan, conduct or subcontract, and report audits of processes, systems, projects and/or sites within budget and established timelines based on approved schedule.
  • Prepare, review Audit reports and CAPAs issued by internal and external providers including assessment and follow up with individuals until closure of any CAPA
  • Ensure the follow-up of major and critical audit findings/Quality issues to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
  • Develop, update and maintain the 3rd party Inventory used by Development including tracking and assessment of validation and audit status, assess with the Senior Quality Assurance Manager GCP/PV/GLP risks associated with each vendor and prioritize for Audit of 3rd party by external consultants or internal resources
  • Assist in the identification of areas of potential Quality risks and compliance issues, assist in the monitoring the overall status of quality and compliance within Development on an on-going basis and escalates issues to Senior Management.
  • Ensure the Quality Assurance database and any other QA related trackers are maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
  • Follow up and drive the process for review and development of SOPs within the Development department and in conjunction with operational members of the Development department
  • Deputize for the Senior Quality Assurance Manager GCP/PV/GLP if required and represent QA on project related activities, such as CPTs, clinical meetings, etc.
  • Organize and deliver training to the Development and other departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
  • Provide regular feedback to the Senior Quality Assurance Manager GCP/PV/GLP on the the above activities
  • Ensure compliance to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other GxP areas
  • Ensure QA databases and trackers are maintained and up-to-date
  • Create Quality metrics on a regular scheduled basis and provide these to Senior Quality Assurance Manager GCP/PV/GLP.
  • Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
  • Maintain an excellent knowledge of current GXP regulations, guidelines, and related auditing techniques appropriate to work responsibilities
  • Ensure compliance of systems regulated by CSV (Computerized Systems Validation)
  • Write/review/approve  QMS documents with GVP and GCP relevance e.g. SOPs, Guidelines
  • Deputize for the Senior Quality Assurance Manager GCP/PV/GLP during his absences

Qualifications and Experience:

  • 2-5+ years of experience in Clinical QA for investigational and marketed medicinal products
  • Excellent knowledge of GCP, Clinical Trials/Operations, Data Management, Regulatory Affairs procedures.
  • Some Knowledge of Computer Systems Validation (21 CFR Part 11)
  • Good knowledge of PV.
  • Knowledge of Electronic AMS desirable.
  • Good communication skills

Apply for this job: Clinical Quality Assurance Manager

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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