Computerized Systems Quality Assurance Lead Consultant (m/f)

REFERENZNUMMER:

375515/11

IHRE AUFGABEN:

-Provide independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with procedures, regulations and guidelines
-Promote and champion support of compliance, quality and best practice oriented culture
-Authorize validation deliverables produced for computerized system projects
-Support development of Computerized Systems Quality Assurance related procedures and drive implementation of pragmatic, compliant, quality based solutions
-Participate in ongoing operational management activities including demand management, Change Advisory Board and Quality Metrics
-Conduct audits of computerized system vendors and 3rd party software providers including SaaS
-Identify and report quality or compliance concerns and take immediate corrective action
-Proactively identify risks/issues and share emerging industry standards/trends
-Plan, execute and report on internal audits of activities, records and processes related to regulated computerized systems and regulated data
-Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with regulatory requirements and industry standards

IHRE QUALIFIKATIONEN:

-Profound knowledge of FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements including 21 CFR Part 11 and Annex 11
-Good work experience with IT systems and teams (virtual and onsite)
-Know-how making quality assurance and compliance decisions in regards to software development, validation and support
-Knowledge of all phases of Computerized System Validation and infrastructure qualification including use of GAMP 5 principles and risk based approach
-Familiar with all phases of System Development Lifecycle principles, processes and procedures
-Previous experience with Validation of SAP in global pharmaceutical environment
-Ability to influenceability to identify root cause of problems
-Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio)

WEITERE QUALIFIKATIONEN:

Quality manager