Our client is a leading global Biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of a number of manufacturing sites, this business has invested heavily in its Biologics flagship manufacturing operation here in Leinster and currently have a requirement for a Quality Operations & Disposition Manager to join the organisations growing manufacturing plant:

The Position

• Manage and oversee the Quality Operations & Batch Disposition team.
• Manage and oversee Regulatory Affairs professionals.
• Review & approval of batch records and associated raw data for manufacturing and testing operations (Drug substance and drug product) to ensure compliance with the requirements of cGMP and batch review and batch disposition process.
• Provide real-time support to the Operations department during manufacturing activities.
• Review & improvement of product quality and quality systems including Annual Product Quality Reviews.
• Review and approval of any changes of critical and major change controls.
• Review of batch & stability analytical data and associated reports.
• Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions.
• Support the inspection process to ensure site conformity with regulatory authorities.
• Manage Site License registration process and future license updates.
• Support internal and external audit programme.
• Review and approve Protocols, Summary Reports and other documentation associated with batch manufacture and ensure compliance.
• Initiate and implement change control activities in accordance with site procedures.
• Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
• Contribute effectively to the site's strategic development as part of the site management team.
• Support the continuous improvement of an effective quality management system including quality oversight across the site.
• Interact with and support the External QA group and contract filling CMO.
• Support new product introduction activities.

The Person

• BSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering).
• At least 5-10 years relevant experience in a Pharma OR BioPharma Manufacturing environment.
• Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
• QP eligibility is an advantage.
• Experience of interaction with cross functional departments.
• Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.
• Excellent interpersonal and communication skills, meticulous eye for detail.

To learn more about this role apply online or contact Trisha Bracken on + 353 1 6321802 for a confidential discussion.