Req ID #: 227202
Keele, England, GB
Full time
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB SUMMARY

Working at our GMP Licenced CDMO facility in Keele, you will be collaborating with Operations, Quality Assurance and Quality Control teams to perform activities under the site Validation System ensuring that GMP compliance is maintained at all times.

• To support the Validation Leader in proactively managing the site Validation System in accordance with the Site Validation Master Plan (SVMP) to defined timelines.
• To oversee and manage on time delivery of all aspects of Validation to GMP.
• To work closely with Operations, QC, QA and Project Management to ensure that the scheduling of Validation work supports project timelines without compromising quality and compliance.
• To plan and prioritise own work.
• Generation of a wide range of documents, including, but not limited to, Validation Plans, URS, DQ, IQ, OQ, PQ, Validation Summary Reports, and maintenance of the SVMP.
• Oversight and attendance of vendor qualification as required.
• Providing ‘in suite’ execution of validation documentation supporting GMP manufacture, QC laboratories and Warehouse storage.
• Investigation and resolution of any errors identified during execution of validation documentation.
• Supporting the Validation Leader in Regulatory ad Client audit preparedness activities and action closure.
• To adhere to proper compliance with Health and Safety of all operations in accordance with Company’s Health, Safety and Environmental policies and procedures.

JOB QUALIFICATIONS

• Science degree (or equivalent) and relevant Pharma / Biotech experience in a Validation, Manufacturing or Quality Assurance role.
• Broad knowledge of pharmaceutical systems and/or processing equipment (e.g. water systems, autoclave, fermenter) in relation to operation and qualification parameters.
• Experience in Regulatory and Client audit preparedness activities and action closure is desirable, but not essential.
• Able to demonstrate strong written, verbal communication skills and practical skills.
• A self-starter, who shows initiative and is a team player.
• Able to work flexibly.
• Ability to deliver on a wide range of programmes of work.
• Excellent problem solving skills and be able to work independently.
• Reliability, integrity and respect of confidentiality on work related and personal matters.

Please refer the Job description for details