QA Systems Manager / Qualified Person
Brighton & Hove, East Sussex
Competitive salary and benefits package
This is an exciting time to join us. Following significant investment and continued growth we are building a new, bespoke manufacturing and pilot plant facility which is under construction and scheduled to be operational during Quarter 1 of 2018.
Working within a dynamic SME environment and established and customer focussed quality culture this is an excellent opportunity to develop your wider business skills. We are looking for a permanent, full-time Quality Systems Manager, who will act as the Qualified Person for our Brighton & Hove sites in conjunction with other named QPs on the relevant manufacturing licences. You will also be responsible for day to day management of the QA Systems team and play a key role within cross functional improvement projects.
Custom Pharma Services is a full-service contract development and manufacturing organisation (CDMO) for investigational medicinal products (IMP) through to commercial manufacturing. Custom’s advanced facilities can produce solid dosage forms with immediate and modified release characteristics, with an annual capacity of more than 1.5 billion tablets and 250 million capsules for both clinical and commercial use.
Fully certified in the UK and Europe, Custom Pharma Services is a one-stop resource for contract development and pharmaceutical manufacturing. When a customer needs a partner that can help with formulation development, stability, analytical testing, QP certification, contract manufacturing, primary packaging, shipment and customer support, Custom Can.
About the role
In summary the roles comprises:
- Ensuring all applicable pharmaceutical Quality Systems are in place, documented, correctly implemented, effectively managed and monitored in compliance with GMP.
- Evaluating GMP/ licence compliance and performing QP certification, as appropriate, of satisfactory products to meet patient, production and market needs.
- Ensuring systems are in place to determine and disseminate customer, company, regulatory and statutory requirements to all departments to achieve compliance
- Manage and ensure cohesiveness of QMS at the Hove & Moulsecoomb sites in accordance with company and statutory requirements
- Management and development of the Quality Systems Team
Qualifications, knowledge, skills & experience required
- Eligible for nomination as a Qualified Person (qualified under the permanent provisions)
- Experience of working with oral solid dosage forms is essential
- Familiar with clinical release certification, (IMP under license) is desirable
- Experience of leading Quality Audits
- Previous experience in a relevant QA managerial role
- Ability to be ‘hands on’ and problem solve in a systematic manner especially with respect to tablet manufacture (preferred)
- Application of Improvement and Risk Management principles
- Excellent Knowledge of current regulations for quality systems and compliance.
- Working knowledge of compendial requirements, analytical techniques and laboratory instrumentation.
- Experience of Continuous Improvement tools and techniques
- Project Management skills
- Energy and drive for compliance in a collaborative and practical manner.
- Committed to ensure the principles of GMP are practiced and applied consistently
- Ability to promote a Quality Culture rather than a policing approach to Quality
- Excellent communication and interpersonal skills with the strength of character to keep a team focussed on objectives and success criteria
- Ability to identify opportunities for process & operational improvements and implement appropriate changes to deliver these benefits
- Passion for “right-first-time” processes and a determination to understand breakdown/failure root cause and prevent reoccurrence
- Ability to train effectively
- Strong facts and figures / statistical philosophy
- Good Presentation skills
- Ability to prioritise and manage multiple tasks and projects with potentially conflicting requirements
Benefits include: Holiday; pension; life assurance; subsidised gym membership; bike to work scheme; childcare vouchers and annual profit related payment.
Free parking onsite with easy access to the A27, 5 minutes’ walk from Hove Station.
How to apply
Please submit your application by clicking the Apply Button by Sunday 30th April, 2017
If you have any questions or would like an initial conversation with our Recruitment Manager please contact them on the number to the right of this advert.
Applicants must have the right to work in the UK.
Successful candidates will be required to complete a basic disclosure check.