Job Description
The Specialist is expected to be a subject matter expert for material management flow and has a flavour for IT systems.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Supporting raw material programs for all new biologics coming to site.
- Ensuring raw material testing proposed is appropriate, GMP, verified, tested, released as per the quality management system.
- Collaborate with a global network of scientists to streamline and platform scientific methods entering site.
- Propose Raw Material testing and specifications, Generation of Global test specifications, ensuring testing is qualified to GMP either internally or externally.
- Partner with the testing laboratories, Warehouse, supply chain, quality to ensure raw materials are released in accordance with GMP & internal procedures.
- Support of the Raw Material Systems Build & Maintenance on Comet & GLIMS .
- Author Raw Material Related Testing Investigations.
- Analyze and optimize current IT lab System business processes for the laboratories and support implementation activities of the technologies and methodologies.
- Works in accordance with applicable internal company regulations: safety, health and environmental protection.
What skills you will need:
In order to excel in this role, you will more than likely have:
- M.S in analyticalchemistry/biochemistryor related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.
- GMP working experience and a working knowledge of regulatory requirements.
- Knowledge of Analytical Methodologies and sound scientific understanding with focus on liquid chromatography and IR spectroscopy.
- Team player with ability to support peer to peer coaching.
- Understanding of current manufacturing processes.
- Expertise in method validations and technology transfers.
- Initiate and support deviations, CAPAs, and, risk assessments, and change records asrequired.
- Author technical protocols and reports as required.
- Effective organizational and multi-tasking skills with strong oral and written communication skills.
- The successful candidate must be self-driven and confident to take ownership of sample management program & be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
So, if you are ready to:
Current Contingent Workers apply
Not Applicable
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