This position is responsible for application of global Quality Assurance operational activities that balance patient safety, domestic and international regulatory requirements and Quality Assurance standards, with clinical supply needs, corporate and development milestones and commercial product launch timelines to biological CMC projects. The role interacts with all Global Teams to verify that Chemistry, Manufacturing, and Controls activities are in alignment with Clinical, Non-Clinical and Regulatory Affairs efforts in support of product development and launch. This position is also responsible for supporting operational activities and requirements for all new biological product candidates, ensuring critical patient safety parameters are met while minimizing time from discovery to clinic based on sound regulatory risk management and mitigation.
- To oversee all QA activities from cell banking through to final release to clinical trial sites.
- Liaise with CMC project teams to ensure timely delivery of clinical trial supply materials.
- Provide CMC teams with information and guidance on Quality related issues.
- Prepare, manage and execute QA project plans.
- Prepare Product Specification Files.
- Review and approve Quality documentation relating to manufacture, testing and release of materials to be used in pre-clinical or clinical trials where appropriate, including those arising from validation and tech transfer activities.
- Provide quality oversight for complex development supply chains encompassing internal and external suppliers of raw materials, drug substance and drug product manufacture and testing related to clinical trial supplies.
- Relevant experience within a Pharmaceutical R&D or commercial environment with a bachelor’s degree or equivalent in Biology, Chemistry or Health Related Science.
- Experience in pharmaceutical Quality related role in a relevant pharmaceutical manufacturing environment.
- Experience in quality systems, quality methods, statistics, product qualification/validation, and a basic understanding of clinical product supply requirement.
- Eligibility to act as a QP / trainee QP would be an advantage.
- Evidence of a high level of proficiency with IT Systems.
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