Job Locations UK-Oxfordshire-Abingdon

ID

2024-1525

Category

Quality

Position Type

Regular Full-Time

This roles primary responsibilities include managing quality records within the Quality Control Group and ensuring the Quality Control group maintains a state of inspection readiness. The role will have oversight of all quality records progressed by the Quality Control group and work with colleagues both within QC and other departments to ensure on time closure of records. The role will also work with QC leadership to develop and maintain inspection readiness of the QC group and support development of procedures to ensure full compliance.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Key responsibilities:

• Maintain oversight of all quality records in Quality Control and ensure timely completion of records.
• Participate in regulatory inspections and submissions
• Generate protocol and report for assay transfers/validation.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports
• Lead or assist with OOS, OOT, and lab investigations as needed.
• Lead QC laboratory equipment introduction and participate in validation activities.
• Interact within internal as well as across other functional group to communicate QC requirements.
• Perform QC testing following Standard Operating Procedures (SOPs).
• Assist with the maintenance of QC laboratory and equipment.
• Manage receipt and storage of QC samples, reagents and maintain retain inventory.
• Coordinate shipping of samples to Milton Park and contract testing laboratories.
• Training others within department for methods and processes according to GMP standards.
• Become SME/Trainer for method or process and lead troubleshooting or method optimization as required
• Line management responsibility for direct reports if applicable

Other responsibilities

• Manage technical studies performed with external companies.
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary.

Preferred Educational requirements:

• A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.

Experience and skill requirement:

• 4 years or more GLP / GMP experience in a relevant work environment.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills

Location:

• This position is based in our Milton Parklocation and typically has a 5-day on-site expectation.

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