MSD Sr Spclst Qualified Person 

Ireland, Dublin 

43794261

Job Description

Bring energy, knowledge, innovation to carry out the following

• Performs review on all commercial drug substance batches manufactured at the site to support release for further processing, ensuring that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation, the principles and guidelines of EC Good Manufacturing Practice or the good manufacturing practice of a third country recognized as equivalent under a mutual recognition agreement.
• The principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records and any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system.
• Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so e.g. any additional sampling, inspection, tests, or checks initiated because of deviations or planned changes.
• Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
• Accountable for ensuring that there is an effective Quality Management System is in place.
• Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
• Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.

Preferred Qualification and Experience

• This role requires a Qualified Person (QP) with a minimum of two years’ experience as named QP on a license.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Technical
• Meet the educational requirements of a Qualified Person as per EU Directives 2001/83/EC and 2001/20/EC.
• Minimum eight years spent in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing roles
• Have detailed knowledge and experience of global health authority regulations and quality and compliance requirements with the ability to effectively convey these requirements, and knowledge of industry best practices for quality and compliance related topics.
• Show strong partnership and cross-functional leadership skills to drive continuous improvement and promote knowledge-sharing and implementation of best practices across the site and Compliance functions on global and local level.
• Have strong verbal and written communication skills, project management skills and ability to influence areas not under direct control to achieve objectives and effectively convey challenging goals and objectives.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

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