Product Quality Lead (12 Month Fixed Term Contract)

Hira Ni; United Kingdom; Presencial; GBP 60 000 - 78 000; Tempo integral

Resumo da oferta

Almac is seeking a Product Quality Lead on a 12 month fixed term contract. The role involves supporting Qualified Persons in batch certification and release, reviewing third party batch records, and ensuring compliance with MA and GMP.

The ideal candidate will possess a Science degree and extensive GMP/ISO experience, with batch record review expertise and sterile fill/finish experience being advantageous.

Qualificações

• Bachelor’s degree (or equivalent) in a Science discipline or significant relevant industry experience.
• Experience within a Quality System in a Pharmaceutical Industry (GMP, ISO).
• Experience in batch record review processes.
• 2:1 Hons (or equivalent) in Chemistry, Biology or Pharmaceutical discipline preferred.

Responsabilidades

• Review third party manufacturing and packaging batch records for semi-finished products.
• Ensure product manufacturing complies with Marketing Authorisation (MA) and GMP.
• Support Qualified Persons in batch certification and release.

Formação académica

Bachelor’s degree (or equivalent) in a Science discipline

Descrição da oferta de emprego

Product Quality Lead (12 Month Fixed Term Contract)

Working as part of the Pharma Services Business Unit, the Product Quality Lead will support the company Qualified Persons in fulfilling their responsibilities for batch certification and release.

The post holder will review third party manufacturing and packaging batch records, for semi-finished products received at Almac for further processing, ensuring that the product has been manufactured in accordance with the Marketing Authorisation (MA) and Good Manufacturing Practice (GMP).

As part of a busy team within a rapidly growing organisation, operating within a challenging industry you will benefit from the numerous personal and professional developmental opportunities available throughout the Almac group.

For a full list of job specific responsibilities please see attached Job Description.

A Bachelor’s degree (or equivalent) in a Science discipline OR or significant relevant industry experience

Previous significant experience working within an established Quality System within a Pharmaceutical Industry (e.g. GMP, ISO)

Previous experience in batch record review processes.

(The following criteria may be applied if a large pool of applicants exist)

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