Position Title: Quality Planning Specialist Department: Quality Report to: Quality Business & Compliance Services Lead Location: Janssen, Little Island Closing Date: 27th September Diversity, Equality & Inclusion: For more than 130 years, Diversity, Equity & Inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our dedication to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to build an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each one of our people feel that they belong and can reach their potential.
No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!
Janssen Pharmaceuticals Sciences UC, operating in Little Island, Cork since 1981, is dedicated to manufacturing bulk Active Pharmaceutical Ingredients (APIs) distributed globally.
Join our team of hardworking individuals who share a passion for making a difference in an environment that empowers you to drive your career.
Position Summary: The position will be located at the Little Island site and will be part of the Quality Team.
This position is responsible for the planning & scheduling of QA and QC activities within Janssen Pharmaceutical Sciences (JPS) UC as required by Good Manufacturing Practice (GMP).
Main duties and responsibilities: * Develop and maintain effective systems, tools and templates to implement planning and scheduling of QC testing and release activities in a streamlined manner using existing systems such as Smart QC.
* Develop and maintain effective systems, tools and templates to complete planning and scheduling of QA release activities in a streamlined manner using existing systems such as Smart QA.
* Develop daily/weekly/monthly resource plans as appropriate in support of production related QC/QA activities (inclusive of consumable planning requirements.
* Publish periodic capability/training gap requirements to the Team Leads to achieve the medium to longer term QC/QA Plans.
* Lead the daily/weekly/monthly cadence of meetings with key internal collaborators to communicate the respective plans/schedules and to adjust as appropriate.
* Attend the Weekly MRP Meeting as the Quality Representative.
* Attend the Weekly Resource Meeting as the Quality Representative.
* Lead the Stability Management process for the Quality team.
* Prepare and publish the Weekly QC/QA Release & Batch Release Metrics.
* Lead the Planning for QA/QC activities for the Reanalysis process.
Key Skills and Proficiencies required: * Builds strong positive relationships.
* Demonstrates ability to work with teams and individuals.
* Seeks opportunities to grow and develop professionally.
* Uses standard methodologies to improve business operations.
* Holds self-accountable for compliant and detailed execution.
* Takes personal responsibility for decisions that successfully build customer value.
* Optimally leads and adapts to change.
* Always demonstrate Integrity and Credo-based actions.
* Ability to work independently, lead their own time and meet deadlines as appropriate.
Education and Experience: * Third level Degree in a science or pharmaceutical field.
* A minimum of 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry.
* Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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