Qualified Person

CK Group are recruiting for a Qualified Person, to join a long-established global pharma company, to be based at their EU HQ in the Home Counties.

The Role:

You will support the Associate Director Quality Operations in the implementation and maintenance of Quality Assurance activities relating to product support used for the manufacture, packaging, testing, storage and distribution of marketed products.

Responsibilities:

• To carry out the legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended and 2001/20/EC
• Review and disposition batches for marketed products in accordance with the UK Code of Practice for Qualified Persons
• QA review and approval of master and executed batch records and associated documents
• Preparation, review and approval of SOPs, review and approval of qualification/validation protocols and reports
• Participation in the execution of the internal and external audit process according to the audit schedules
• Ensuring the ongoing compliance of the manufacturing facility, including implementation of new GMP requirements
• Ongoing training, coaching and mentoring of staff in GMP and compliance

Your Background:

• Full QP qualification
• Experience with oral solid dose or sterile products

• Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines and an understanding of the manufacture and packaging of pharmaceutical products
• Ability to establish and maintain effective working relationships and communication links within the manufacturing unit, affiliated organisations and other customers

• Ability to interpret complex data and present key findings
• Ability to conduct audits internal and externally

• Ability to act as a mentor in support of Quality staff development

Salary:

• • Competitive with an excellent benefits package

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 143532 in all correspondence.

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INDCP