Oxford BioMedica (UK) Limited

Operational Support Officers, GMP Manufacturing

Location
Oxford
Salary
Competitive
Posted
08 Feb 2021
Closes
08 Mar 2021
Ref
OXB MAN 21-138
Discipline
R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Do you want to feel inspired every day?  We are future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 Oxford Biomedica’s Manufacturing Team is responsible for the production and aseptic fill and finish of vectors and vaccines, for our clients and partners, to GMP standard.

We are looking for talented GMP production professionals to work as Operational Support Officers to plan and schedule core manufacturing operations to ensure compliance and operational efficiency.

Your responsibilities in this role would be:

  • The generation and maintenance of a detailed weekly production schedule derived from the master production schedule, accounting for operational challenges
  • Maintenance of cleaning schedules and BMR and label requests
  • Coordinating delivery of parts to expedite flow of materials to meet production schedule
  • Generation and maintenance of IFS product structures
  • Utilising ERP system to auto‐generate manufacturing work orders
  • Coordinating between warehouse supply chain and  manufacturing on material shortages including the implementation of appropriate change controls to introduce new or replacement materials
  • Reviewing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up actions/corrections of GMP documentation.
  • Advising operators on best practises for document completion, review and follow up actions or escalate if required
  • Assist in the capture of GMP data for the incorporation into Continuous Process Verification tables
  • Coordinating with engineering for repair and return of process critical equipment
  • Coordination of introduction of new equipment and maintenance of manufacturing equipment files
  • Coordination with engineering and validation for scheduling of validation, calibration and maintenance activities.

To be successful in this role, you will have the following skills and experience:

  • Higher National Certificate or Degree in Science discipline or relevant experience
  • Significant working knowledge of GMP manufacturing activities ideally across differing functions
  • Knowledge of planning/materials management systems (Computerised ERP or manual) in GMP.
  • Adept in establishing and routine use of scheduling tools.
  • Skills and knowledge in requirements for GMP compliance
  • Understanding and experience of Change Controls
  • Understanding & experience of Good Documentation Practice and Data Integrity (ALCOA+)
  • Experience in document control or records management systems in a regulated environment
  • Proven organisational & problem solving skills

Collaborate. Contribute. Change lives

We look forward to receiving your application

No agencies please.

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