Job Description

A new and exciting opportunity has arisen to join us on our journey in Dublin Biotech as we look to hire a Qualified Person (QP) to join our existing Quality team.

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.TechnicalMeet 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 rolesHave 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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/1/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R330712