Beschreibung
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
MAJOR ACCOUNTABILITIES:
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
IDEAL BACKGROUND:
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 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 favourable 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 (eg FDA, EMA GMP, GLP, GCP, Records Management, BC/Disaster Recovery)
BRINE SA is a solid, Swiss company with an impeccable reputation on the IT market for offering top IT professionals to major customers for their projects. We offer a speedy and professional solution by carefully selecting suitable consultants and IT-specialists on the basis of their qualification. We pay particular attention to their education, business and technical knowledge, professional experience, individual character and not least, personal preferences. We employ them while they work on our customer projects, take care of their payrolling, and generally strive to ensure they feel comfortable in their work environment, whether regarding business and technical issues, or administrational ones.
Interested? If yes, then please send me your Curriculum Vitae.
Work location: Basel
Start: 04.05.15 till 31.12.2015
Duration: 8 months
Permits required: EU citizen or valid work permit
Workload: 100%
Language: English, German a plus
Ref: PS1751