Category: Job Adverts

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.

Valneva 13/05/2020

Qualified Person

An opportunity has arisen at Valneva Scotland Ltd for a Qualified Person.

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs, with a sterile vaccine manufacturing facility near Edinburgh. This opportunity comes at a very exciting time in the lifecycle of the site and the Company.

The role is site-based with the responsibility of overseeing quality of both commercial manufacturing and the multi-product IMP facility cleanrooms and the associated processes, ideally on a full time, permanent basis.

The Candidate:-

The ideal candidate will be qualified as a QP under the permanent provisions, preferably with previous biological products experience and ready to be named on the MIA. A biology qualification or equivalent with a minimum of sterile dosage form manufacturing and release experience are required.  Experience in a vaccine production environment would be a strong advantage.

The ideal candidate would also demonstrate the following competencies:

  • Proven ability to make confident decisions based upon sound justification
  • Proven ability to apply problem solving skills to a wide range of issues while maintaining a positive attitude towards those involved
  • Proven ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out
  • Demonstrable ability to adapt to change and implement change accordingly

Key responsibilities:-

  • To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; to represent the company to external authorities on liaison with MHRA, FDA and OMCLs on; product defect reporting, recall and Inspection related matters
  • To advise the Director of Quality Operations/Site Director/Corporate Bodies on any matters arising which impact on supplier or service provider status, the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
  • To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subjected to temperature excursions, Product Technical Complaints, etc. and communicate to customers
  • Maintain oversight of Valneva’s Quality Management System, including implementation and maintenance of Standard Operating Procedures, as required. To prepare and/or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions. To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements

Find out more about Valneva at www.valneva.com

If you feel this role is a fit for your skills and attributes and would like to further discuss how well Valneva’s Quality Culture suits you and vice versa, or to simply apply, please send an e-mail and your CV to LIV-HR@valneva.com and we will get in contact with you.