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Johnson & Johnson is currently seeking for an In Process Control Analyst, in Little Island, Cork.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/
What you will be doing:
This position is responsible for supporting Operational requirments on a Shift basis carrying out tasks and projects related to Manufacturing Equipment Cleaning/Changeover and testing procedures at Janssen Pharmaceuticals Ireland as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
What impact you will also have:
- Provide cross functional support and expertise to onsite cleaning processes – cleaning logs, protocol & report review/approval.
- Perform cleaning analysis including but not limited to monitoring, evaluation and validation, in particular swabbing, inspections, residue on evaporations, insoluble matters and analysis of swabs of production equipment including final sign off of equipment cleaning logs.
- Performs routine and non-routine analytical testing activities. Initiates and support NC’s as part of this process.
- Trains other QC analysts in laboratory methods and procedures when required.
- Executes validation testing in line with Technical Operations , operation, maintenance, calibration and troubleshooting of equipment and its associated software.
- Review and approval (where appropriate) of laboratory test results.
- Ensures that testing and results approval are completed within agreed turnaround times.
- Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
- Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.
- Deals with non-conformances/ deviations in an accurate and timely manner.
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
คุณสมบัติ
We would love to hear from you, if you have the following required requirements:
- A third level qualification in a scientific/technical discipline required.
- A minimum of 3 years experience in a laboratory-testing environment within the pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
Key individual contributor competencies:
- Builds strong productive relationship.
- Demonstrates ability to work with teams and individuals.
- Asserts personal ideas and opinions using persuasion to influence others.
- Seeks opportunities to grow and develop professionally.
- Uses best practices to improve business operations.
Significant Environmental, Health & Safety considerations:
All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.
What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
IMPORTANT
This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.