In this role, you will author GMP related documentation including Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs), playing a key part in advancing our mission and making a real difference.
Responsibilities
* Writing clear and concise GMP documentation such as BMRs and SOPs to support lentiviral vector manufacturing for clinical and commercial use
* Coordinating and prioritising document creation, updates and reviews with manufacturing teams and subject matter experts to meet project timelines
* Initiating and managing document updates based on change controls and manufacturing schedules across all suites
* Ensuring consistency across GMP documents, assessing the impact of changes and escalating issues to relevant experts
* Participating in project meetings and communicating document update progress to stakeholders across departments
* Acting as subject matter expert for GMP documentation in support of manufacturing activities and regulatory audits
* Identifying and driving improvements in GMP documentation in collaboration with manufacturing teams and experts
* Maintaining high ethical standards and delivering high quality work consistently
Qualifications
* Experience of authoring clear and concise GMP documentation such as SOPs or BMRs.
* Strong knowledge of GMP and regulatory documentation requirements.
* Competent user of MS Office applications especially MS Word.
* Attention to detail to ensure documentation is free of errors and a keen interest in scientific writing in a highly regulated field.
* Experience working with electronic document management systems and an understanding of document workflows.
Benefits
* Competitive total reward packages
* Wellbeing programmes that support your mental and physical health
* Career development opportunities to help you grow and thrive
* Supportive, inclusive, and collaborative culture
* State-of-the-art labs and manufacturing facilities
* A company that lives its values: Responsible, Responsive, Resilient, Respect
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