Support quality and compliance for commercial manufacturing: perform batch record review and disposition, oversee certification, manage deviations and investigations, apply cGMP and regulatory requirements, use SAP/Trackwise, and drive continuous improvement of Quality Systems.
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are you Ready?
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Quality Specialist to join our growing operations in Europe. The role of a Quality Specialist in CAI is to:
· Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.
· Performs Batch Disposition preparation, Batch record review, Certification process oversight.
· Strong cGMP and regulatory requirement understanding.
· Experience in SAP release, SAP deviation system and Trackwise.
· Support all quality and compliance requirements for and leading to commercial manufacturing.
· Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
· Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
· Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
· Ensure the highest Quality, Compliance and Safety standards
· Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
Position Requirements:
· 5+ years' experience within GMP regulated facilities
· Proven track record in Quality and Compliance.
· Professional Quality Assurance Accreditation desirable
· Bachelor’s degree in a science or equivalent discipline
· Experience with Aseptic manufacture desirable
· Experience of batch record review and product release essential
· Excellent oral and written communication skills in English
#LI-JD1
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.
Top Skills
Cgmp
SAP
Trackwise
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