Overview
Quality Assurance Specialist Jobs in Boxmeer, North Brabant, Netherlands at MSD Netherlands
Title: Quality Assurance Specialist
Company: MSD Netherlands
Location: Boxmeer, North Brabant, Netherlands
The QA Specialist is a position within the center of excellence Quality Operations CoE QO consists of several departments that have been set up with the aim of confirming that the production activities are carried out in accordance with Good Manufacturing Practices (cGMP). These activities consist of producing, receiving, storing, testing, processing, releasing, packaging, labeling and distributing products throughout their shelf life. The QA spevcialist is part of the QA-IPT department.
The main goals of the position QA officer are advising, supporting and approving equipment installation, qualification and validation, advising and supporting root cause investigation and approving documented research in case of deviations and reviewing and approving standard production documentation and protocols.
Review and approve templates for production and filling instructions.
Supporting root cause research.
Informing and involving the Qualified Person in the event of deviations with potential impact on product effectiveness, safety or compliance.
Review and approve root cause research and related conclusions.
Review and approve corrective and preventive actions.
Review and release of change control proposals.
Supporting qualification and validation activities in the role of subject matter expert.
Review and approval of qualification and validation protocols/reports.
Performing witnessing activities during media simulations and operator qualifications.
Education/Knowledge/Experience
HBO working and thinking level.
Good GMP knowledge.
Willingness to support change.
Knowledge of and experience with biological and/or pharmaceutical chemical production processes.
Applies knowledge of internal and external guidelines and expectations regarding compliance in the execution of daily activities.
Applies knowledge of local and global guidelines and legislation to ensure product compliance.
Applies knowledge of guidelines, expectations regarding compliance in supporting adjustments/improvements in internal quality policy
Has basic knowledge of MPS and improvement processes and the application to individual situations.
Demonstrates awareness of processes to reveal opportunities for improvement.
Uses knowledge of product development and production processes to maintain relevant quality oversight based on the existing quality systems.
Applies technical and scientific knowledge to assess data and ensure that equipment, systems and processes operate within defined parameters.
Applies an understanding of risk management processes to identify risks to ensure product safety, effectiveness and quality of our products.
Has extensive knowledge of the quality system model and understands the advantages and limitations of each component
Understands the connection between the quality system and the quality policy.
This is a temporary position, more information will be provided upon application
