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The QA Releaser will ensure continuous compliance of the Compounding Unit to cGMP, 'Specials' manufacturing requirements, local procedural requirements, and Baxter Corporate policies. This role involves making QA decisions during manufacturing, inspecting and releasing final products, supporting operational improvements, resolving quarantine and audit-related issues, and ensuring documentation standards.
Job Responsibility:
Support manufacture of aseptically products by making QA decisions during batch manufacturing and ensuring GMP is adhered to at all times
complete documentation and batch reviews as required
inspect and release final products as per Company policies
support Production in the review and post compounding check operations
support delivery of product release targets, including ensuring timely batch review activities and batch disposition of any deviations with impact to product release
proactively identify and support implementation of continuous improvement opportunities in QA and Operations
ensure timely completion of all GMP commitments
ensure timely communication of significant GMP and product quality issues to QA Management
align with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements
ensure facility and process compliance through attendance of Gemba activities, identifying actions and facilitate implementation
implement and sustain EMS principles
support release and Quarantine area issues, where required
facilitate the implementation of an ‘Audit Ready’ compliant site which is always ready for MHRA, corporate, internal or 3rd party audit
support the completion of audit findings and fully investigate to find the root cause and actions to address the audit findings are carried out in a timely manner
Requirements:
Degree or BTEC (or equivalent) in Pharmaceutical or Science related subject preferable but not essential
at least 2 years experience in a GMP environment
strong work ethic and able to work flexibly to meet the needs of the business
uncompromising commitment to Quality
ability to communicate effectively to all levels of the organisation
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