Location: Ilkeston, DE7
Department: Quality
Reporting to: Quality Manager
The Role
We are currently looking for an experienced Site Quality Lead (Officer) to join our client's team in Ilkeston.
This is an excellent opportunity for an experienced Quality professional to take a key role in supporting the maintenance, implementation and continuous improvement of the site’s Quality Management System (QMS).
Working closely with Production, Warehouse, Maintenance and Supply Chain teams, you will provide day-to-day quality leadership across the site, helping to maintain high standards of compliance, product quality and continuous improvement.
You will also act as Deputy to the Quality Manager, taking responsibility for coordinating site quality activities and supporting quality decision-making and escalation of compliance risks during their absence.
Key Responsibilities
You will support the effective maintenance and continuous improvement of the site’s Quality Management System, ensuring activities are carried out in accordance with company procedures, regulatory requirements and customer expectations.
The role will involve reviewing and maintaining quality documentation, including SOPs, work instructions, quality policies, forms and records, as well as supporting document control, change controls, quality risk assessments and continuous improvement initiatives.
You will lead and support investigations into deviations, non-conformances, complaints and quality incidents. This will include facilitating root cause analysis, identifying effective corrective and preventative actions (CAPA), monitoring trends and escalating significant quality concerns where required.
You will also be involved in batch manufacturing record reviews and documentation checks, supporting batch disposition and product release activities while ensuring manufacturing records are complete, accurate and compliant.
Auditing will be an important part of the role, including conducting internal audits and self-inspections and supporting customer, supplier and regulatory inspections. You will help ensure audit findings are addressed effectively and that the site remains audit-ready.
Working closely with operational teams, you will provide routine shop-floor quality support and guidance, helping to investigate and resolve quality issues and promote a strong Right First Time culture throughout the site.
The position will also support validation activities, including equipment qualification, process validation, cleaning validation and periodic reviews. You will coordinate site calibration schedules and monitor the timely completion of servicing and maintenance activities relating to quality-critical equipment and systems.
As Site Quality Lead, you will provide coaching and guidance to colleagues on quality requirements and compliance expectations, lead quality improvement projects and contribute to quality-related management reviews and business objectives.
About the Products
The successful candidate will provide quality oversight for the manufacture and release of sterile products ensuring products are manufactured in accordance with applicable quality and regulatory requirements while maintaining patient and consumer safety.
About You
You will have a strong understanding of GMP and Quality Management Systems, ideally gained within a pharmaceutical, medical device, healthcare or other regulated manufacturing environment.
You will have experience of quality investigations, root cause analysis and CAPA management, together with strong auditing skills and a good understanding of validation, change control and risk management processes.
Excellent report writing and documentation skills are essential, along with strong organisational and project management abilities.
You will be confident working across different departments and have the ability to influence, support and challenge colleagues where appropriate to ensure quality and compliance standards are maintained.
Good IT skills, including Microsoft Office and electronic quality systems, are required. Knowledge of ISO 13485, ISO 9001 and relevant regulatory requirements would be advantageous.
Experience Required
You will ideally have a minimum of 3 years’ experience within a GMP-regulated manufacturing environment, preferably within pharmaceutical, healthcare, medical device or another highly regulated industry.
You should have demonstrable experience managing quality investigations and CAPAs, conducting internal audits and supporting external audits.
Experience reviewing manufacturing documentation, supporting batch release activities and contributing to validation and quality improvement projects is also required.
Previous experience in a Senior Quality, Quality Lead or Deputy Quality Management role would be advantageous.
What We’re Looking For....
We are looking for someone who takes ownership and accountability for quality outcomes and leads by example.
You will demonstrate integrity in everything you do, continuously look for opportunities to improve and work collaboratively with colleagues across the business.
A strong team-focused approach is important, together with the ability to build effective working relationships and promote a culture where everyone is working towards the same goal.
If you are an experienced Quality professional looking for an opportunity to take the next step in your career and play a key role in maintaining quality, compliance and continuous improvement across a regulated manufacturing site, we would be keen to hear from you.
Please submit your cv and contact Karen Barker (Agency) (phone number removed) for an immediate discussion
Salary description
£30000.00 - £35000.00 per year