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.
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 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 update batch documentation, standard operating procedures and associated forms.
- 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.
- Support delivery of strategic projects such as the introduction of Tulip incorporating improvements to Logbooks and introduction of Electronic Batch Records.
- Promote 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.
- Perform GEMBAs of the processes; look for continuous improvement opportunities and support operational excellence initiatives.
Qualifications
- 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.
- Experience working with an Enterprise Resource Planning (ERP) system is desirable.
- 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.
Education & Licenses
- Ideally holds qualifications gained in the pharmaceutical industry e.g., NVQs or similar.
EEO Statement
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
Benefits offerings, including but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
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