Job Description
Organon are recruiting for a Qualified Person (QP) to join our world class manufacturing site in Cramlington, Northumberland. In this role, you’ll be responsible for ensuring that all products manufactured by our company and by the Toll manufacturers are manufactured, assembled and analysed in accordance with regulatory guidelines to meet both internal and external customer demands in accordance with Good Manufacturing Practice (GMP).
This position can be on part time or full time basis.
Role Responsibilities
1. Perform QP release of solid oral dose product batches in accordance with 2001/83/EC (As incorporated into UK Law).
2. Participate in manufacturing, packaging and customer complaint investigations from the quality perspective with respect to area of product responsibility. Lead significant investigations and the fact-finding investigation process as appropriate.
3. Provide technical and operational support for Integrated Process Team (IPT) Quality activities including batch document review and validation document review and approval.
4. Review and approve Standard Operating Procedures (SOPs), equipment change control and qualification documentation.
5. Provide proactive support and initiate quality improvements within IPT. Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems and training and coaching of relevant personnel.
6. Conduct supplier audits as required and participate in the internal audit program in support of the site audit team and permanent inspection readiness.
7. Maintain knowledge of current guidelines and GMP’s in line with duty for continual professional development.
8. Provide training and mentoring to the IPT Quality group and IPT members.
9. Provide quality oversight of toller activities, the Third Party Logistics (3PL) and Active Pharmaceutical Ingredients (API) suppliers.
10. Ensure awareness of a material’s performance at the supplying site through annual reviews, customer complaint histories, change controls and knowledge of Quality Agreement terms between approval and receiving sites.
Role Requirements
1. Eligible to act as a Qualified Person (QP) for the certification of Marketed products in accordance with UK legislation and EU directives 2001/83/EC.
2. Knowledge of manufacturing and packaging documentation, change control, qualification and validation process.
3. Experience of using SAP, MES, LIMS, Orion and site deviation management systems.
4. Be knowledgeable in error risk reduction, SOP systems, Quality systems, Site Safety, cGMP, 5s and visual management.
5. Excellent verbal and written communication skills, with the ability to interact with a wide range of people both internal and external including the Regulatory Agency.
6. Good decision-making skills (method judgement and risk), flexible to current and new situations.
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.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.
Search Firm Representatives Please Read Carefully: Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites 10%
Flexible Work Arrangements: Not Specified
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s):
Number of Openings: 1
Requisition ID: R516635
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