Product Release Co-ordinator

1 week ago


Cramlington, Northumberland, United Kingdom Organon Full time
Organon are recruiting a Product Release Co-ordinator to join our world class manufacturing site in Cramlington, Northumberland.

In this role, you will be responsible for supporting and contributing to enhance Cramlington site compliance to all regulatory and quality requirements, operating within established quality systems.

This role will be primarily based in the Packaging IPT Quality Bill of Materials team.


This is a great time to join our team as it grows and evolves a unique opportunity to act as the main quality point of contact for Organon Cramlington in leading/acting as an advisor on Quality/Compliance matters, ensuring that all activities follow the correct processes and procedures in a maximized and efficient way in accordance with appropriate internal and external guidelines.


Role Responsibilities:

  • Perform quality reviews of component changes, revision level updates, new packs and engineering change orders.
  • Support the qualified person to ensure that all products manufactured at Cramlington and UK tollers are manufactured, assembled, and analysed.
  • Ensure all products released for sale have been manufactured in terms of the Product License and in accordance with GMP.
  • Perform GMP review of batch records and associated data, including review of regulatory impact tables to support QP release of batches in accordance with SI 2012/191
  • Participate in manufacturing and packaging investigations from the quality perspective with respect to area of product responsibility.
  • Perform Quality approval of appropriate level of manufacturing and packaging investigations in accordance to cGMP requirements.
  • Provide technical and operational support for Quality activities including validation document review and approval and change control approval where appropriate.

Role Requirements:

  • Degree in Chemistry, Pharmacy, or other scientific statistical discipline
  • Experience in pharmaceutical industry.
  • Knowledge of error risk reduction, SOP systems, Quality systems, cGMP.
  • Knowledge on deviation management change controls, understanding of the pharmaceutical quality management system
  • Familiarity with manufacturing processes, IT systems, LIMS and documentation management systems.
  • Analytical thinking, determination, and decisionmaking skills.


Organon is a Women's Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women's health.

Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.


We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.


At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.

It's going to be an exciting future—come be a part of it

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives.

We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.

We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.


Our Vision is clear:
A better and healthier every day for every woman.

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R516429

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