Qa Validation Manager

3 weeks ago

Cork, Cork, Ireland Merck Life Science Full time

Work Your Magic with us
Ready to explore, break barriers, and discover more?
We know you've got big plans – so do we
Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
We are looking for a committed QA Validation Manager to lead our Validation processes at our Cork facility, ensuring adherence to all relevant regulations and standards.
This role will also address site safety requirements alongside applicable GxP and Good Manufacturing Practices (GMP).
Key Responsibilities
Develop and manage comprehensive validation processes and procedures, including the upkeep and execution of the site Validation Master Plan and Data Integrity Governance Plan.
Oversee compliance with software and hardware validation regulatory requirements, such as 21 CFR parts 11, Annex 15 (Eudralex), GAMP, and other pertinent guidance documents.
Offer validation support and expertise for various projects, which includes creating Validation Plans, conducting validation impact assessments, system risk assessments, protocols, and reports.
Assist in regulatory submissions, failure investigations, CAPA initiatives, and ongoing improvement efforts.
Build and maintain collaborative relationships across the facility and with external customers to ensure quality and regulatory compliance in validation activities.
Prepare validation reports, data, and Key Performance Indicators for senior management presentations and Management Reviews.
Cultivate the leadership and operational skills of direct reports, establish career development plans, identify training needs, and set individual goals and objectives.
Conduct regular performance evaluations and provide constructive feedback.
Who You Are
Bachelor's Degree in a quality or science-related field (e.g., chemistry, biology, or medical technology) or equivalent professional training.
At least five (5) years of experience in drug manufacturing, medical devices, biologics, or a related industry.
Demonstrated experience in supervising and motivating teams, managing objectives, and conducting performance reviews.
In-depth knowledge of GMP, FDA regulations, SOP development, and a strong grasp of Validation and Data Integrity Principles.
Excellent analytical and problem-solving abilities, with a knack for presenting findings in clear, impactful reports.
Proficient in IT tools, including Microsoft Word, Excel, and PowerPoint.
Strong communication skills (both written and verbal), with the ability to effectively collaborate and present at all organizational levels.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology.
We are committed to creating access and opportunities for all to develop and grow at your own pace.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity
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