Join a dynamic team where your skills will contribute to critical projects in the
healthcare manufacturing sector
. This role offers the opportunity to work in a challenging environment that prioritizes compliance and quality, making a significant impact on operations.
As an ideal candidate, you are a knowledgeable
Validation Specialist
eager to apply your expertise in ensuring regulatory compliance and quality assurance. If you possess a keen attention to detail and a strong commitment to excellence, this is a fantastic opportunity for you.
* You develop, implement, and execute URS, CAT, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for small scale equipment in QC and Manufacturing.
* You perform qualification of systems following industry standards, ensuring adherence to cGMP, cGLP, and internal procedures.
* You maintain compliance of qualified systems with cGMP at all times.
* You support projects in alignment with Sanofi and relevant regulatory standards.
* You stay updated on emerging validation regulations and provide technical assistance on US FDA and EU requirements.
* You take responsibility for validation documentation from approval through implementation.
* You assess changes to determine their impact on qualified status and validation documentation.
What are we looking for?
* You have between
2-4 years of experience
in a healthcare manufacturing environment.
* You possess knowledge of
cGMP requirements
in a regulated environment.
* You are familiar with relevant quality and compliance regulations.
* You have the ability to troubleshoot validation issues effectively.
* You demonstrate good knowledge of quality management systems.
* You are detail-oriented and capable of managing validation documentation.
* You are proficient in
English
.