Labelling and Packaging Lead
Location: Edinburgh BioQuarter
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.
Your new role
* An exciting opportunity to join our Manufacturing team as a Labelling and Packaging Lead.
* A key role which will lead labelling and packaging operations across all RoslinCT, ensuring compliance, cross-functional coordination, and technical support for manufacturing projects.
* Lead a small team within Manufacturing (OQIT); providing supervision, coaching, guidance and training.
* Formulate detailed layouts micro-flows and operating processes assuring compliance with regulatory requirements.
* Process mapping and risk assessment exercises to drive process improvements.
* Ensure batches are labelled and packaged correctly and released on time.
* Responsible for the planning of phase in/phase out changes related to commercial, quality, or regulatory strategies.
* Proficient in completing QMS, resource planning and capable of assessing and developing strategies for new requirements.
* Support the review and management of RoslinCT document types including Standard Operating Procedures (SOPs) to ensure compliance with company policies.
* Ensure Quality Management work is completed within agreed timescales.
About you
* Minimum 5 years’ experience in GMP Manufacturing.
* 2-5 years' experience in labelling and packaging within a GMP environment.
* Working experience following SOPs and using technical RCA and FMEA techniques.
* Prior cGMP regulations experience, particularly within aseptic processing, documentation and record management.
* Working knowledge of MHRA, FDA, EMA, PICS and ISO regulations.
* Proven track record of successfully supervising a team in a GMP environment with the ability to lead colleagues through various projects and initiatives.
* Project management experience within a client facing environment.
* Strong Microsoft Office and Bartender skills – preferable experience in an electronic quality management system package such as Q-Pulse.
Qualifications
Next Steps
If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.
At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.
We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.
If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [emailprotected]. We’re here to assist and make things as smooth as possible for you.
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