Custom Pharma QA Systems Manager / Qualified Person

Permanent, full-time

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 2021.

Working within a dynamic SME environment with an 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.

Company Description

About Custom

CPS is a full-service “Clinical to Commercial” CDMO and holds various licences to operate a range of services which includes MIA, MIA(IMP), MS, WDA(H), API and ManA.  CPS is an independent OSD specialist pharma contract services provider. CPS produces a range of formulations including modified release and potent products such as hormones at low dose. New development and commercial manufacturing facilities for high potency contained processing are under construction at a site adjacent to our existing Brighton, Moulsecoomb packaging and QC facilities.

About the role

In summary the role 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
  • Deputise for the Senior QA Manager/QP in clinical and development activities as required
  • Management and development of the Quality Systems Team

About You

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, (previously named on an MIA(IMP) licence) is desirable
  • Experience of leading Quality Audits
  • Previous experience in a relevant QA managerial role. Consideration will also be given to candidates who would like to develop their management skills
  • Ability to be ‘hands on’ and problem solve in a systematic manner especially with respect to oral solid dose 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; health plan: subsidised gym and annual profit related company and individual bonus payment based on successful performance.

Free parking onsite with easy access to the A27, 5 minutes’ walk from Hove Station.

How to apply

Please submit your application via the following link to our vacancy pages:

Click here to apply

If you would like an initial discussion with our Recruitment Manager please email:  Jane.Austen@custompharma.co.uk

Strictly no agencies

Applicants must have the right to work in the UK.

Successful candidates will be required to complete a basic disclosure check.