Senior Batch Release Officer
International Pharmaceutical Manufacturer requires a Senior Batch Release Officer. The post holder will:1)Plan, drive and support the review and release of batches.2)Trend, track and participate in daily updates for batch release priority.3)Understand deviations and changes related to batch review in order to be able to assess them on behalf of the QP and advise team.4)Complete GMP reviews of batch documents where required. 5)Identify and address any hindrances in a dynamic manner and support batch release team.6)Complete batch review monitoring as required with any local spreadsheets or logs.7) Understand and complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise8)To undertake work related job objectives as directed by QA management.9)Ensure compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice are adhered to within the team. 10)Oversea and organise the batch release priority list work load in order to meet set targets for release.11)Be committed to, and passionate about, providing the highest quality standards within the team and across the business, whilst appreciating business needs. The ability to form relationships across the organisation is essential for success.
Duties will include:·To be primary QA contact for batch release and document review.·Participate in daily updates for batch release priority.·Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP.·Complete GMP reviews of batch documents·Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.·Complete batch review monitoring as required with any local spreadsheets or logs.·Complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise·To undertake work related to job objectives as directed by QA management.·Maintain an ongoing dialogue with Quality Operations Management to ensure quality targets and objectives are able to meet business priorities.·Lead a team of QA Batch release Officers in the completion of their day to day activities, ensuring objectives, targets and workload are achieved and distributed within the team.·Highlight risks to product quality, patient safety and/or data integrity throughout the quality lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.·Deputise for the QA Batch release supervisor where required.·Coordinate the batch review process to ensure these are progressed in a timely manner and issues resolved prior to QP dispostion.·Lead and organise batch release and related activities as required to meet business needs.·Identify skills and competency development needs within the team. Support individual and team development through the training and coaching processes. ·Review and communicate key performance indicators for the team and implement actions to improve these where necessary.·Ensure that the performance of your direct reports meet the standards (competence and behavioural) required by the company.·Escalation to Quality Operations Management, at the earliest opportunity, when issues or obstacles that impact compliance or on time delivery.·All other tasks and duties, as necessary, to maintain the effectiveness of the batch release process as required by the business and/or Quality Management.
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