A fantastic opportunity to join a Global Pharmaceutical Manufacturing Organisation as a Manufacturing Compliance Specialist on a contract basis for 3 months. This key level individual will ensure that production areas are in compliance with current GMP standards and regulatory requirements and ensure audit readiness at all times. The role reports directly into the Production Manager.
The job holder does not work on a single discreet job at a time, and is required to work on several activities from the following list simultaneously:
- To investigate and document incidents of manufacturing deviations or abnormal occurrences and to assess the impact on product quality and to recommend corrective and preventive actions to prevent reoccurrence
- To track NCR’s & perform effective actions for timely closure.
- To perform Quality Risk Assessments and Root Cause Analysis related to manufacturing operations
- To perform agreed actions within CAPAs for timely closure.
- Creation of effective Production Quality Improvement Plan (QIP), control & report progress against plan on a regular basis.
- To review and update where required Production related SOP’s.
- To review and approve other types of GMP documentation such as Process Amendments, and to advise on the content of Batch Manufacturing Records and Batch Packaging Records for QA approval.
- To perform internal audits of all Production areas and produce reports with findings / actions and track actions to closure
- To attend daily planning meetings.
- To report to line manager ongoing workload and progress against objectives, formally weekly.
- This list is not exhaustive
To succeed in this challenging, people focused business, you will have
- The job holder must be educated to degree level in a science-based subject or demonstrable equivalent experience, with a minimum of 5 years’ experience in the pharmaceutical industry, to include manufacturing & QA
- Presentation skills, and the ability to train personnel in quality matters are required
- The job holder should have good report writing, statistical evaluation and effective meeting skills.
- The job holder requires good computer skills, and must be able to produce structured technically detailed documents using Microsoft Word, Excel etc
- A growing, multi-national business with a track record of delivering the highest quality products to a prestigious client base
- Focused on achieving growth alongside an efficient and productive manufacturing environment.
- Worldwide leader in the development and manufacture of pharmaceuticals.
Interviews are to be held shortly, and suitable candidates will be contacted within 24 hours of application.
To apply for the role, please send your CV and salary details to Unimed Consulting using the ‘Apply Now’ button. If you would like to have a confidential discussion on the role, you can contact the Consultant, (Tarnya Sharp) quoting the job reference number (TS5024)
Please note, we endeavour to make sure you will receive an email indicating if you have been successful or not within 1 to 2 weeks.
Unimed Consulting: Our technical and manufacturing recruitment brand is well respected for the high quality of work we have delivered for both clients and candidates. Our in-depth knowledge of recruitment across the Healthcare sector enables us to provide advice based on experience and to give you the best access to client vacancies.
Job Type: Contract