Compliance Analyst

Description:
Quality/Compliance Functional Analyst
GxP
CFR part 11
SDLC
Quality Systems
TrackWise
Documentum

Responsibilities:
•Partner with key business partners in various Medical Affairs functions to understand and define the strategy and opportunities to further enhance the existing Quality System used for SOP Management, Deviation Memos, and other quality workflows.
•Business project lead for the implementation of new workflows in the area of Pharmacovigilance, Market Quality, and others.
•Work closely with both the assigned IT partners (onsite and offshore) as well as business key users.
•Translate the functional requirements into workflow design, workflow configuration and testing
•Ensures completeness, accuracy and consistency of the documentation
•Planning and control of acceptance testing
•Manages user access to the Quality System
•Supports key users and end users with training in the Quality System
•Customer will provide all necessary system training in the Quality System (TrackWise, Documentum) as well as in the relevant validation methodology used (SDLC)

Technical skills:
21 CFR Part 11 * 3+ Yrs.
Documentum * 3+ Yrs.
GxP * 3+ Yrs.
HP Quality Center * 3+ Yrs.
Pharma Experience * 3+ Yrs.
SDLC * 3+ Yrs.
Trackwise * 3+ Yrs.

Personal skills:
•Some flexibility in working hours is required (occasional over-time or weekend/holiday work) •Accepts personal responsibility
for client satisfaction •Strong tracking, coordination and project planning skills •Establishes and manages engagement objectives,
expectations and quality plan •Ability to identify and implement process and/or application improvements •Strong analytical and
problem-solving skills •Must be able to work on multiple simultaneous tasks with limited supervision •Quick learner, motivated
self-starter •Excellent customer service, interpersonal, communication and team collaboration skills •Able to follow change
management procedures and internal guidelines Methodology/Certification requirements •Master and/or Bachelor Degree in
Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course
work in technical systems plus continued education in technical disciplines is preferred •Additional certification is a plus
Language proficiencies •Excellent English skills both spoken and written •Dutch is a plus