1. Job Summary
To generate batch documentation in accordance with Fisher SOP’s, GMP and GCP Guidelines and client requirements.
To work with the Packaging Client Services Project Managers to assist with defining Client requirements for batch documentation, and to advise on best practice.
2. Job Duties and Responsibilities
- To liase, with Packaging Client Services Project Managers, Co-ordinators, QA, CAD and Operations where appropriate to enable creation of project documentation and to ensure it proceeds in a timely and controlled manner in line with project and process requirements.
- Generation of Production orders in GPM and associated documents including change orders, in conjunction with the information provided by the Client Services Project Managers.
- Participate in Job Initiation Meetings in a technical capacity ensuring that the technical challenges of new projects are discussed and resolved at an early stage. Attend Close out meetings to review the success of projects and participate in continuous improvement opportunities where appropriate.
- To manage online operational issues and work to resolve issues to ensure that operations continue with minimum disruption.
- Understand and follow all Fisher Standard Operating Procedures relevant to Batch documentation generation.
- Act as the GPM users for the Client services dept ensuring that GPM issues are investigated and resolved quickly in conjunction with GPM super uses and the IT dept.
- Documentation administration tasks where appropriate to facilitate the documentation process.
- Identify opportunities to improve and revise Fisher Standard Operating Procedures for the purposes of process improvement.
- Obtain a working knowledge of Trackwise to enable investigation reports to be completed.
- Participate in the training of new staff.
3. Decision Making / Financial Authority
- Production order structure and content.
- No financial authority.
4. Principal Contacts
- Team Leaders, Project Managers & Project Co-ordinators. In addition regular contact with QA, Operations, Scheduling, CAD technicians and warehouse.
5. Education / Qualifications
- GCSE or equivalent in relevant subjects.
6. Experience /Skills
- Computer literacy.
- Previous experience of pharmaceutical packaging and/or Regulatory Affairs an advantage.
- Must have and be able to maintain a high attention to detail.
- Must be able to work independently and possess problem solving ability.
- Must be adaptable and be prepared to assist with other duties within the section during busy periods.
- Builds Customer Allegiance
- Embraces PPI
- Focus on Growth
- Job Knowledge
- Interpersonal Skill
- Flexible attitude
- Personal Development
- Problem Solving/Decision Making
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