Product Quality Lead (Various Locations)

Job title:

Product Quality Lead (Various Locations)

Company

Almac Group

Job description

Product Quality LeadLocation: Craigavon or DundalkHours: 37.5 hours per weekSalary: CompetitiveBusiness Unit: Pharma ServicesOpen To: Internal and External ApplicantsRef No.: HRJOB10322ㅤThe RoleAs a key member supporting the company Qualified Persons in batch certification and release responsibilities, the Product Quality Lead will undertake various critical tasks to ensure compliance with Good Manufacturing Practice (GMP) and Marketing Authorisation (MA) requirements.This role involves reviewing third-party manufacturing and packaging batch records, as well as quality system documentation, to guarantee that products have been manufactured in accordance with regulatory standards and licences throughout their lifecycle.The Product Quality Lead will participate in the review of Drug Substance release documentation, communicate with external customers to address queries during batch record review, and coordinate batch record review schedules to support onsite packaging operations effectively.In addition, the Product Quality Lead will play a vital role in proactively identifying factors that could impact Qualified Person (QP) release, assisting in the generation and coordination of QP Declarations, and reviewing and providing Quality Assurance approval for executed batch records at Almac Pharma Services.By participating in audits, both internal and external, and staying updated on industry regulations and guidelines related to GMP and Quality Management, the individual will contribute to improving efficiencies, ensuring ongoing compliance, and maintaining high-quality standards within the pharmaceutical industry.ㅤKey Requirements· Have eligibility to work in the UK/Ireland OR possess a valid work permit that will allow you to take up full time employment in the UK/Ireland for the relevant location.· A bachelor’s degree (or equivalent) in a Science discipline· Previous significant experience working within an established Quality System within a Pharmaceutical Industry (e.g. GMP, ISO)· Previous experience in batch record review processes.ㅤDesirable Requirements· A minimum of a 2:1 Hons (or equivalent) in Chemistry, Biology or Pharmaceutical discipline· Experience in the manufacture and / or packaging of solid oral dosage products.· Experience of sterile fill/finish or biologic manufacture.· Experience in customer facing role.· Experience in a QP supporting role.ㅤFurther InformationThere are 2 positions available – one is a full time permanent position, the second is a full time fixed term maternity cover.The working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00.You will also be eligible for hybrid working following the successful completion of probation.This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role. Successful applicants based at the Dundalk site should be prepared to travel to the Craigavon site for training purposes when required.ㅤApply NowApply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.ㅤClosing DateWe will no longer be accepting applications after 5pm on 16 January 2025ㅤRECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Expected salary

Location

Craigavon, Co Armagh

Job date

Fri, 03 Jan 2025 23:28:36 GMT

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