QA Systems Manager / Qualified Person in Brighton
Brighton, East Sussex Competitive Adzuna
|Salary and Benefits:||Competitive|
|Post Code:||Not specified|
ENG TR2 United Kingdom GB Brighton England Cornwall (Show on map)
QA Systems Manager / Qualified Person 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. 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. 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. QA Systems Manager / Qualified Person responsibilities: |
• 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 QA Systems Manager / Qualified Person requirements: We would like to hear from you particularly if your profile includes:
• Eligible for nomination as a Qualified Person (qualified under the permanent provisions)
• Experience of working with oral solid dosage forms is essential
• Experience of leading Quality Audits
• 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 Preferred background would include:
• Previous experience in a relevant QA managerial role. Consideration will also be given to candidates who would like to develop their management skills
• Familiar with clinical release certification, (previously named on an MIA(IMP) licence) is desirable
• Ability to be 'hands on' and problem solve in a systematic manner especially with respect to oral solid dose manufacture About Custom Pharma Services (CPS): 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. Location: Brighton Hours: Full Time, Permanent Salary: Competitive Benefits: 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 Strictly no agencies please. Ref: 93435 This job was originally posted as www.totaljobs.com/job/90369324
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