QA Officer GMP (Interim)

For our client in Noord-Holland we are looking a Quality Assurance Officer GMP on an interim base. In this varied role as (Senior) GMP Quality Assurance Officer you are responsible for supporting GMP Quality Assurance activities as directed by the Head of Quality Assurance.

Job Objectives and Responsibilities

-Responsible for supporting all GMP activities from a QA perspective
-Reporting the status of the quality system to the Head of QA and advising to realizing improvements
-Support the Operations department in maintaining and developing GMP systems
-Ensure that activities are performed in accordance with cGMP
-Advise regarding quality issues for both internal as external stakeholders
-Write, review, evaluate and manage GMP documentation
-Responsible for planning, organizing, executing, reporting and follow-up of internal and external audits
-Operate as GMP/GCP trainer in introductory and regular training sessions
-Review and approve quality improvement documentation such as deviations and change control documents
-Perform investigations assigning root cause and managing associated risk
-Involved in keeping the training and documentation system up to date
-Inspection and release of incoming raw materials
-Review of Batch Productions Records and Validation Reports
-Report findings of batch review to the Qualified Person for batch certification/ release of final products, working closely with the QP
-Support other aspects of the Quality System as required including GLP and GCP
-Participate in project teams as the Quality representative for GMP

 

-In possession of HBO/University or related experience or education in Biology, Pharmacy, Chemistry or related
-Work experience in the biotech or pharma industry is a pre-requisite
-Relevant (3+ years) work experience within Quality in a GMP environment
-Hands-on mentality with an affinity for technical systems, processes and technology
-Experience of leading projects or teams within a regulated environment is desirable
-Experienced in relevant computer software (MS Office); affinity with documentation systems
-Attention to detail
-Ability to perform accurate and detailed work
-Applies a methodical approach to completing all tasks
-Acts in accordance with policies, processes and procedures
-Good oral and writing communication skills, in both Dutch and English
-Strong interpersonal and relationship building skills
-Professional, flexible and proactive attitude, team-oriented

 

A challenging position in an international enviroment. Do you have any question please contact Evelien Luijt (06-11596826).