Beschreibung
Reference #:
5573WS
Industry:
Pharmaceuticals
Location:
Basel und Region
Start:
ASAP
Duration:
8 Months renewable
Role:
Project/Process Quality Manager
The Global QA (eCompliance) Manager is responsible for providing Quality Assurance support on behalf of the business with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in global procedures. QA eCompliance provides the single point of contact for guidance on CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables and major changes for global systems and projects
Main responsibilities:
- Reviews and Approves relevant system life cycle 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 (Pharma QSS)
- Reports potential CSV global compliance issues, when applicable.
- Contributes to managing, assessing and resolving GxP critical deviations from an e-Compliance perspective
Skills:
- Graduate in Engineering, Pharmacy, Chemistry, Natural Sciences, Information Technology or several years (? 8) of equivalent experience in pharmaceutical or related regulated industry.
- 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 eg, 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
- Skilled in risk assessment methodologies, and project organizations
- 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 (eg FDA, EMA GMP, GLP, GCP, Records Management, BC/Disaster Recovery)
Language(s):
Excellent written and verbal communication skills. Fluent in English, German is an advantage