Job Details
Job ID: 131
Job Title: Quality Operations Administrator
Job Type:
Hire Type: Direct Hire
Level: Entry Level
Recruiters: Hannah Woodward,Sophie Taylor
City: Harefield
Country England

Job Description
Description: • Support for Senior Director Manufacturing and Operations Quality

• Support Artwork & Change Control Manager

• Support Materials Quality Manager

• Support Distribution Quality Manager
Requirements/Qualifications: - A scientific / technical degree is desirable.
- Experience in a medium to large sized organisation and knowledge of EU/FDA guidelines for the manufacture and distribution of pharmaceutical products.
- Previous vacation/placement work experience if newly graduated.
- A working knowledge of Quality Management Systems is desirable.

- The ability to be creative and flexible while maintaining compliance will be critical to the success of this position.
- Analytically strong with highly developed knowledge and ability to use IT systems, particularly MS Word, Excel and Powerpoint to enable process improvements and the conversion of data into meaningful business information.
- An eye for detail.
- Project management experience desirable but not essential, well developed planning skills with ability to meet deadlines required.
- Excellent verbal and written communication skills.
- A team player.
- Excellent networker with the ability to collaborate and agree outcomes.
- Ability to communicate effectively with Norgine business partners.
Responsibilities: • Support for Senior Director Manufacturing and Operations Quality
- Administrative support for Senior Director Quality Operations
- Development of presentation slides
- Manage Quality Operations meetings, agreeing agenda, managing presenters and taking and distribution of minutes
- Follow up on assigned actions from meetings

• Support Artwork & Change Control Manager
- Routine management and maintenance of the Global Change Control documentation (CR forms);
- Update and maintenance of the change control tracker;
- Monitoring and collation of change control metrics;
- Monitor and follow up of actions; escalate issues to Change Control manager and/or redirect queries to sites point of contact;
- Schedule Triage meetings; redact the agenda and minutes;
- Liaise with change owners, functional experts and Production, R&D and others to obtain data required in support of global change requests, to ensure timely submission / approval / implementation of global changes.
- Support and track training of Change Control system

• Support Materials Quality Manager
- Routine maintenance of the Supplier Documentation system;
- Support the Materials Management Senior QA Associate in developing the Supplier Documentation system
- Update and maintenance of the Approved Supplier List;
- Monitoring and collation of Material Supplier metrics;
- Monitor and follow up of actions; escalate issues to Materials Quality manager;
- Support and track training of Materials Management system

• Support Distribution Quality Manager
- Support the Distribution Quality Manager in developing the Distribution route compliance data
- Support routine management and maintenance of Distribution master data/information;
- Monitoring and collation of Distribution metrics;
- Monitor and follow up of actions; escalate issues to Distribution Quality manager

(i) Complexity
• General Administration
o Understanding needs of the director when traveling. Ensuring that all stages of travel are “joined up” and achievable to ensure safety with suitable levels of hygiene
• Organisation of meetings
o Quality Operations meeting
o GQET meeting
o CC meeting
• Development of presentations
o High quality slide decks to support presentations
o Able to visualise concepts and design presentation slides.
• Data base and KPI’s
o Maintenance of data base for Quality Operations KPI’s
o Change Control data
o Distribution data
o Materials data

(ii) Accountability

• Setting and maintaining meeting schedules
• Ensuring that documentation for meetings is clear understandable, a true reflection of actions agreed and distributed in a timely fashion.

(iii) Relationships

• Senior management and technical teams to organise and support meetings
• Senior Director M&S Quality for day to day support and assistance with research
• Quality and Regulatory Affairs staff for administration of Change Control requests
• Norgine administrators to ensure smooth operation of own activity and
• External organisations to support Quality M&S activity outside of

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