QA Project Manager

Basel  ‐ Onsite
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Description

Reference #: 915333NC
Industry: Pharmaceuticals
Location: Basel und Region
Start:
Duration:
Workload: 100%

MAJOR ACCOUNTABILITIES:
-Reviews and Approves relevant system lifecycle documentation relating to validation and validation changes from a content/e-Compliance perspective Approves changes and deviations, failure Investigation and CAPAs associated with GxP computer systems (operational changes according change control process)
-Provides guidance on Computerized System Validation (CSV) and Data Integrity.
-Acts as the interface between the Business, the IT and the QA organizations for CSV related topics.
-Reports performance metrics, where relevant and project status updates to Global QA (eCompliance) Manager (PharmaQSS)
-Reports potential CSV global compliance issues, whenapplicable. Contributes to managing, assessing and resolving GxP critical deviations from an e-Compliance perspective

Education:
-Graduate in Engineering, Pharmacy, Chemistry, Natural Sciences, Information Technology or several years (8) of equivalent experience in pharmaceutical or related regulated industry.

Experience:
-Minimum of 8 years plus experience in a combination of risk management, Quality Assurance, information security,compliance and IT jobs
-Strong working knowledge of CSV and eCompliance related systems e.g., SAP in a GxP environment.
-Expert knowledge in one of the following: GLP, GCP or GMP compliance in one or more global regulatory requirements (FDA, MHRA, EMA, etc.)
-Working knowledge in all areas of compliance in one or more global regulatory requirements.
-Ability to negotiate favorable outcomes while maintaining positive working relationship

Skills:
-Skilled in risk assessment methodologies, and project organizations
-Excellent written and verbal communication skills. Fluent in English, German is an advantage
-Interpersonal and collaborative skills
-Ability to communicate quality, compliance, security and risk related concepts to technical and nontechnical audiences
-Strong organizational and IT project management skills, scheduling and resource management
-Familiar with compliance requirements (e.g. FDA, EMA GMP)
Start date
11/2015
Duration
29/01/2016
From
ITech Consult AG
Published at
23.10.2015
Project ID:
1006964
Contract type
Freelance
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