Quality Risk Management Specialist
4 months ago
Organon are recruiting for a Quality Risk Management (QRM) Specialist to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the Quality Risk Management programme, maintaining and developing a sustainable QRM process aligned to the Quality Management System (QMS) requirements.
**_ We are open to discussing the possibility of part-time, flexible or hybrid working_**_._
**Role Responsibilities**:
- Coordinate and at times lead execution of risk assessments, risk control, and risk communication and review.
- Ensure site risk register and inventory is maintained and communicated.
- Ensure compliance to all regulatory and company requirements.
- Provide governance support and execute QRM activities.
- Ensures Cramlington QRM programme is in alignment with the Global QRM vision.
- Support the site QMS for implementation and continuous improvement.
**Qualifications, Skills and Experience**:
- Previous experience in pharmaceutical manufacturing environment ideally in a quality role.
- Knowledge of cGMP and/or Quality System regulations.
- Technical understanding of manufacturing processes
**Secondary Job Description**
**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**
**Annualized Salary Range**
**Annualized Salary Range (Global)**
**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**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R520662
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