Port Elizabeth - Global pharmaceutical company requires an Analytical Method Transfer Specialist to be accountable for the execution of all Analytical and Microbiology requirements related to all product transfers.
You will lead a team of qualified resources and work across teams to identify and resolve issues and interdependencies to realise executional timeliness and certainty.
Responsibilities : Responsible for identification of key risks, allocation and oversight of qualified resources executing methods transfers, methods validation and all analytical and micro activities : Identify testing labs.
Analytical method transfer to the plant including process-fit-to-plant activities. Develop and execute Method Transfer / Validation plans.
Staff, coordinate and provide oversight to all applicable activities, i.e. documentation, sampling, testing, reporting, investigations, tracking, COA’s.
Accountable for readiness to support project and commercial activities. Escalate critical issues to the Project Lead, drive rapid resolution, proactively identify potential solutions and trade-offs Provide project status updates as required and actively participate in TO Core Team meetings and complete assigned deliverables.