Production Compliance Lead

At Allergy Therapeutics our mission is to transform lives by breaking new ground in immunology treatment. As global pioneers of convenient treatment for allergy and immune\-related disorders, we are entering an exciting new chapter in our history with the launch of a new, innovative product in one of our European markets, bringing new growth and opportunities for us as business and for our people.

We are looking for a Production Compliance Lead to be the key point of contact for the Production teams with regards compliance activities. Responsible for developing, implementing, and maintaining compliance standards to meet expectations within the relevant Production department.

*The salary for this role is £31,300 per annum, working 37\.5 hours per week Monday to Friday (flexibility to suit the individual and business needs). Please note that this is a site based role.*

Our benefits include:

• Free onsite parking, location very close to East Worthing railway station


• Monday to Friday working


• 25 days holiday, plus bank holidays, with an increase after 3, 5 and 10 years


• Real career opportunities with the chance to follow technical, science or management pathways


• Pension, private healthcare, income protection and life assurance


• Access to remote GP, physio, and employee assistance, as well as a variety of deals and discounts

We are looking for someone with experience in a GMP production role as well as experience of root cause analysis.

You will be able to demonstrate strong analytical and problem solving skills as well as strong communication skills as you will be working with stakeholders from different areas with the business.

You will be part of a fantastic team and part of a company who aim to transform patients’ lives and the lives of those around them Working as part of an innovative team, we can offer opportunities to develop your skills and grow your future career with us. can improve your skills and grow a career with us.

The role

Quality Management System

• Participating in the development and maintenance of departmental SOPs to support the operations


• Acting as Lead Investigator for departmental non\-conformances and complaint investigations, working across the teams to ensure effective root cause analysis identified in timely manner


• Delivering Corrective and Preventive Actions (CAPA) and Effectiveness Checks to agreed deadlines


• Take ownership of change control for department


• Author, implement and manage lifecycle of Protocols and Method Statements

• Act as key contributor to departmental Inspection Readiness program


• Ensure team compliance to Plan Do Check Act (PDCA) cycle

• Identify and assess potential compliance risks within the teams


• Support local risk management process

• Collaborate with cross\-functional teams to interpret and implement regulatory requirements effectively


• Work with Operational Quality, Sterility Assurance and Production Teams to ensure best practice embedded within team both procedurally and culturally

• Work with Production SMEs to ensure departmental SOPs are maintained in line with current and best practice

• Contribute to departmental program of Continuous Improvement including 5S and other Lean initiatives as appropriate.

Successful candidates will be invited to an initial video call via Teams and then those who are suitable will be invited to a 2nd stage interview onsite, this will involve a tour of the facility.

About us

Allergy Therapeutics is a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.

We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Driving convenience; our ultra\-short course treatments make life easier.

We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.

*Document Management, Production Documentation, Production Administration, Administration roles in Manufacturing*

Pay: £31,300\.00 per year

Benefits:

• Company pension


• Cycle to work scheme


• Free flu jabs


• Free parking


• Health \& wellbeing programme


• Life insurance


• Private medical insurance


• Referral programme

• Worthing BN14: reliably commute or plan to relocate before starting work (required)

• Do you have experience in a GMP production role with experience of root cause analysis?


• Have you worked in a similar role before? (please detail)

• United Kingdom (required)

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