Overview
Quality Assurance Specialist (Sterile / Aseptic experience essential)
Location: Little Island, Cork
Duration: 12 months
Hours: Full time, 39 hours per week
Imagine your next project as a Quality Assurance Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!
Responsibilities
* Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
* Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates.
* QA Review and Approval of SOPs, Work Instructions and forms from other departments.
* Attendance at Daily/Weekly Operations led Team Meetings.
* Responsible for Gemba Walkdowns & Inspection
* Readiness Walkdowns from a QA perspective.
* QA review and approval of Warehouse Shipping Picklist.
* Primary QA point of contact for Quarantine Shipments.
* Responsible for Batch Book Filing & Archival.
* QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
* Initiation and ownership of QA non-conformance records.
* Confidential - FOIA Exemptions Apply in U.S.
* Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
* Primary Quality point of contact for attendance at Root Cause Analysis meetings.
* Primary QA point of contact for the Returns process.
* Assisting with Audits
How to succeed
The successful candidate will be able to build strong relationships, have excellent communication skills, have the ability to work with teams and individuals. They will also bring:
* A minimum of 3 years of experience within the Pharmaceutical Industry
* ESSENTIAL - Requires strong experience and knowledge with sterile/aseptic environments
* Third level Degree in a science or pharmaceutical discipline.
* A working knowledge of quality processes and systems is desirable.
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
* Experience with preparing for Audits
Benefits
This role offers a very competitive hourly rate. This contract will run for a 12 month duration.
You are welcome here
Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
About Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
Janssen Ireland: https://www.janssen.com/ireland/
Application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.
Questions
If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk
Diversity, Equity & 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 commitment 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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.
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