I am currently working with a dynamic and rapidly growing Contract Development and Manufacturing Organization (CDMO). This company specializes in Good Manufacturing Practice (GMP) manufacturing of Advanced Therapy Medicinal Products (ATMPs) and related products. Their services also include comprehensive process development and ancillary services.
At this innovative company, they are dedicated to supporting the development of complex, breakthrough therapies that cater to a globally diverse market. They pride themselves on being at the forefront of revolutionary medicine, where life-threatening diseases are treated with cutting-edge ATMPs.
The BMR Digitisation Specialist will initially be responsible for the translation of paper Batch Manufacturing Records to an electronic system and the subsequent lifecycle management of the eBMR Templates. You will become the company subject matter expert for digitised BMR.
Key responsibilities will include:
* Translate existing ‘paper’ BMR into the eBMR system
* Working with BMR SMEs to drive forward digitised by first intent for new BMR
* Responsible for the life-cycle management (upgrade, migration and retirement) of digitised BMR
* Maintaining an awareness of feature enhancements for the eBMR System
* Assisting in bi-annual upgrade schedules for the eBMR core platform
You will have the following experience/qualifications:
* Excellent written and verbal communication skills
* Excellent organisation and time-management skills
* Analytical with a high level of attention to detail
* Experience in the use of GxP Software Systems (desirable)
* Experience in the use of BMR (desirable)
Growth Potential:
This role offers a unique opportunity for career growth. The ideal candidate will transition into a hybrid role, incorporating responsibilities as a Computerised System Validation (CSV) Specialist. This will include upgrading the BMR system, with full training provided to support your professional development.
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