Quality Assurance Officer - Dalkeith, United Kingdom - RoslinCT

RoslinCT

Verified Company

Dalkeith, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Quality Assurance Officer - Quality Systems

Location:

Shawfair, Dalkeith

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here

Why join us?

The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
A generous salary package we reward our people at the level they deserve.
31 days of annual leave, plus 4 public holidays which increases with tenure.
A competitive company pension scheme to help you save for the future.
Group Life Cover you are automatically covered for three times your basic salary to give you and your family peace of mind.
Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your dream role

An exciting opportunity to join our high performing team as a
Quality Assurance Officer

You will be a key member of our Quality Systems team within the wider Quality Assurance department.
You will hold responsibility for supporting the management and effectiveness of the RoslinCT Quality Management System (QMS) and establishing effective systems to monitor QMS compliance.
Perform data collection and analysis for KPIs, participating in management review meetings and coordinate reporting of the Annual Product Quality Review.
Develop and manage a system to monitor key QMS elements ensuring timely completion of actions and QMS commitments.
Develop and implement the site Inspection Readiness Programme.
Support the hosting of external inspections and customer audits by managing preaudit, audit execution, and audit response activities.
Ensure a selfinspection programme is in place, supported by trained internal auditors and aligned with current regulatory focus and expectations.
Ensure systems are in place to ensure GXP changes are adequately documented, assessed, implemented, and verified.
Ensure RoslinCT MIA(IMP) licences remain correct and up to date.
Proactive identify and support implementation of continuous improvement opportunities within the Quality Systems group and the wider business.
Initiate and progress artwork process when new specifications are provided by clients including ensuring adequate control are in place, approval of artwork change controls and development of the artwork process.

About you

Experience in working in a GMP biologics or pharmaceutical environment.
A clear understanding of GMP, regulatory, and accreditation systems and quality management.
Excellent skills in Microsoft Office and an electronic quality management package.
Excellent communication and interpersonal skills and a proven track record in negotiation whilst maintaining effective relationships.
Ability to learn and share knowledge with the management team and wider team where appropriate.
Exceptional organisational and planning skills with the ability to multitask in a fastpaced environment
Excellent attention to detail with a real desire to continually develop and improve our processes.

Qualifications
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