Overview
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.
Responsibilities
- 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 documentation, root cause determination and corrective and preventative actions are introduced or initiated as agreed and on time.
- Report compliance failures or unusual trends.
- Author and update batch documentation, standard operating procedures and associated forms.
- Be flexible with working hours to ensure availability to complete production processes that overrun.
- Maintain training records by ensuring all relevant training and competency assessments are completed before undertaking unsupervised tasks.
- Carry out work in a manner that does not adversely affect health, safety, security or the environment and report any shortcomings in arrangements.
- Support delivery of strategic projects such as the introduction of Tulip incorporating improvements to Logbooks and introduction of Electronic Batch Records.
- Provide regular status updates on current workload.
- Promote quality expectations throughout the department, challenge incorrect behaviours and act as Point of Contact (POC) and ambassador for area of specialism.
- Collaborate with all areas of the KSP Jazz Supply Team, B750 Production and QA to resolve and prevent issues.
- Perform GEMBAs of the processes and identify continuous improvement opportunities to support operational excellence.
- Undertake other activities indirectly related or unrelated to the above accountabilities as assigned by the Line Manager.
- Make independent decisions on the impact of processes and procedures.
- Manage internal and external stakeholders through effective communication.
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 and workload through effective prioritisation.
- Operate in accordance with Jazz corporate values of Integrity, Collaboration, Passion, Innovation and Pursuit of Excellence.
- Actively look for and implement improvements in productivity and efficiency within own work area.
- Can differentiate between critical, major and minor issues.
- Experience with Enterprise Resource Planning (ERP) system is desirable.
- Approachable and willing to assist colleagues/team where required.
- Willing to share ideas and information to improve own team and wider company performance.
Education & Licenses
- Ideally holds qualifications gained in the pharmaceutical industry (e.g. 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.
Equal Opportunity
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Benefits
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
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