Brief Description:

The Batch Processing Record Reviewer is responsible for ensuring all batches processed in B750 Extraction Facility have Batch Manufacturing Records completed in compliance with requirements. This requires all processing steps to have been completed and documented with respect to ALCOA+ principles and all Critical Process Parameters (CPPs) having been met prior to approving the manufacturing review. Any deficiencies must be documented and where appropriate deviations raised and referenced. The Job Holder must ensure compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements at all times.

Essential Functions/Responsibilities

Production operational activities

• Perform Production review of Batch Manufacturing Records as scheduled ensuring they are clear, complete and in compliance with company procedures, regulatory requirements and GMP requirements prior to release to QA.

• Lead and support departmental investigations (including deviations and complaints) ensuring that they are fully documented, that the root cause has been determined and that corrective and preventative actions have been introduced or initiated as agreed and on time

• Report compliance failures or unusual trends

• Authors and updates batch documentation, standard operating procedures and associated forms

• The nature of the work requires the Job Holder to be flexible with regards to working hours to ensure that they are available to complete a production process should it overrun

• Ensure training records are kept up to date by taking personal responsibility for own training and ensuring all relevant training and competency assessments are complete before undertaking tasks unsupervised

Safety

• Carries out their work in a way that will not adversely affect their own or others’ health, safety and security or the environment and reports any shortcomings in Jazz arrangements.

• The Job Holder has legal duties under the Health and Safety at Work Act 1974, requiring them to take reasonable care for their own and others' safety, cooperate with employer safety measures (like training and policies), use equipment correctly, and report hazards or defects.

Projects

• Supports delivery of strategic projects such as the introduction of Tulip incorporating improvements to Logbooks and introduction of Electronic Batch Records

Other

• Provide regular status updates on current workload

• Promotes the importance of quality expectations throughout the department positively, challenging incorrect behaviours in others and acting as Point of Contact (POC) and ambassador for area of specialism

• Work with all areas of the KSP Jazz Supply Team, B750 Production and QA, developing working relationships with them to help resolve (and prevent) issues. Performing GEMBAs of the processes

• Look for continuous improvement opportunities and support operational excellence initiatives

• Undertake other activities indirectly related or unrelated to the above listed accountabilities as assigned by Line Manager

• Able to make independent decisions on the impact of processes and procedures • Manages internal and external stakeholders through effective communication

Required Knowledge, Skills, and Abilities

• Working knowledge of Office IT packages including Microsoft Office

• Excellent interpersonal skills and the ability to work as part of a team or independently

• Excellent attention to detail and written communication skills

• Ability to manage time/workload through effective prioritization

• Operates in accordance with the Jazz corporate values of Integrity, Collaboration, Passion, Innovation and Pursuit of Excellence

• Actively looks for and implements improvements in productivity and efficiency within own work area

• Ability to differentiate between critical, major and minor issue

• Experience of working with an Enterprise Resource Planning (ERP) system is desirable

• Approachable and willing to assist colleagues/team where required

• Willing to share ideas and information in order to improve own team/wider company performance

Required/Preferred Education and Licenses

• Ideally holds qualifications gained in the pharmaceutical industry ie NVQs or similar

• Proven experience in the use of Quality Systems and management of Quality events such as deviations, OOS, Change Control and CAPA in Pharmaceutical or other scientific related industry.