Quality assurance specialist - operations

POSITION SUMMARY This position will report directly to the Rathdrum Site Quality Operations (QO) Lead and will serve as partners alongside other stakeholders to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready.

The Rathdrum QA Specialist-Operations will have responsibility for ensuring that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with c GMP and the associated regulatory requirements.

The QA Specialist- Operations may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Batch Release on a case by case basis where needed, once trained to do so POSITION RESPONSIBILITIES Key objectives of this position include : Provision of Quality oversight and support for Operations in the following key area / activities; manufacturing, testing, packaging and material management across all phases of development and commercial manufacture in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures.

Provide in plant / on the shop floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities including but not limited to Batch Manufacturing and Analytical Testing, Deviations, Change Control, CAPA's and Training Review / Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR) Issuance of Batch Records and Cleaning Records Review of executed Batch Records and Cleaning Records as per site procedures.

Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.

Quality Business Partner for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful