Cobra Biologics - GMP Operator

Job Title:

GMP Operator

Category:

Technical roles

Closing Date:

26/03/2021

As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking for additional experienced GMP Operators to support the growth of our Product Delivery team.

The Role

Working within a GMP production environment the role will be varied and will include:

• The manufacture of clinical and commercial products in accordance with EU GMP / FDA regulations
• To form part of multidisciplinary teams in a cleanroom production environment
• To support and maintain the status of the GMP production facility clean rooms.
• Compliant execution of GMP processes according to Manufacturing Plans and Batch Manufacturing Records.
• Ensure production logbooks and Batch Manufacturing Records are completed and maintained according to Cobra Standard Operating Procedures.
• Prepare, review and revise production documentation (eg Standard Operating Procedures, Material Specification Sheets)
• Escalation and reporting of non-conformance events
• Contribute to continuous improvement and investigations as part of the Quality Management System.

About You

You will be educated to A level or equivalent, a BSc or equivalent degree level qualification is desirable. Candidates who do not have academic qualifications but can demonstrate extensive relevant experience in this area will be considered.

Proven clean room experience is highly desirable; if you do not have practical clean room experience, you will be able to demonstrate a strong knowledge of GMP. You will also have previous biologics experience, either in an academic or industrial setting. You must be flexible in your approach to work and willing to work additional hours to accommodate processing. 

In addition, you will be fully conversant with Microsoft Office; the enthusiasm to learn and the ability to interact and communicate effectively with colleagues at all levels within the organisation are also essential.

This role will be based at Keele, Staffordshire, however, a willingness to travel within the Group will be required.

Please apply at: GMP Operator (cobrabio.com)