We are hiring for a Quality Systems Manager for a successful and growing Contract Testing Organisation in the Pharmaceuticals industry. This is a permanent role salary is up to £40,000. You will be responsible for day to day management of the Quality Systems Team to ensure effective / efficient use of resource to fulfil the Quality Assurance and Pharmaceutical Quality Systems (PQS) compliance requirements of the site
What you’ll do:
This role will broadly ensure PQS is fit for purpose, harmonised across the sites and in compliance with statutory requirements and company policies.
Additionally this role will ensure there is a system for the assurance of the Quality of all Materials and Components used on site. API, Excipients and Critical Packaging Components Risk assessments/ traceability are done and kept up to date to assure the quality of products they are used in.
You will be responsible for ensuring all validations and qualification activities are executed and processes, equipment, facilities, utilities, cleaning methods, analytical methods and computer systems are under GMP/ GxP control. You will manage the change control system, ensures adequate documentation, progress and change management across all GMP impacting systems and activities.
The role holder will also keep check that all Documentation on site, which directly or indirectly impact on all aspects of the quality of products, are defined, in control, in date and the Documentation Management system is effective to ensure control of associated activities. Approving / updating documentation i.e. Site Master File and Quality Manual, batch manufacturing and packing documentation
Further this position will ensure all Technical Agreements are in in line with product quality and GMP, timely recording and resolution of non-conformances, quality deviations and investigations.
Drive Quality Improvement, assisting the production and implementation of Production Quality Improvement Plan, and achievement of site KPI’s associated. Internal/ External Audits, monitoring of GMP standards within Production.
Preparation, of/for regulatory inspections and follow-up, completing actions on observations within timescales.
Act as a Quality & GMP Subject Matter Expert (SME)
We are seeking a quality professional with time served in Quality Systems ideally within the pharmaceutical industry. You will have a strong awareness of cGMP, current legistlation, and quality management systems with experience of writing/maintaining QMS documentation, audits and examples of upkeep of standards with your prior employers.
A strong team player is vital to the success of this role and much / all of the above will impact on others within the business, the ability to mentor / motivate and empower colleagues to drive the key objectives around the Quality Management System in their own teams will be important. We are seeking therefore a strong communicator with motivational skills.
On this occasion, LiCa Scientific Ltd is acting as an employment agency. To apply please email email@example.com or call 0161 300 9192 with any informal enquiries.