Senior RAQA Specialist

We are looking for an experienced professional to manage contractor manufacturing operations and ensure compliance with applicable regulatory requirements, ensuring the product dossiers are created and maintained. Self-motivated and able to function effectively within team is essential. This key position will be responsible for meeting, within a demanding environment, strict timelines and protocols but also building and maintaining positive relationships with management, peers, and subordinates.

key responsibilities will be: * Conduct audits of CMOs, CROs, and other service providers, write audit reports and follow up on observations/CAPAs * Perform in-phase inspections in support of GLP studies, write inspection reports, follow up on observations/CAPAs, and prepare QA statement * Review of GMP controlled documents such as master batch production records, test methods, specifications and managing implementation of required changes to meet GMP and internal standards * Review executed batch production records ensuring compliance with approved procedures and GMP expectations. Communicating and resolving discrepancies with CMO * Review release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards * Provides support in the review of change controls related to manufacturing * Provide QA support for validations including reviewing protocols and reports * Working collaboratively with development, manufacturing, and QC staff to respond to and resolve deviations and incidents * Follow through on corrective and preventive actions from deviations, OOS and audit observations * Maintain databases for investigations, audit observations and CAPAs * Review, analysis, and trending of data related to production, testing and stability * Write and review Standard Operating Procedures as needed * Ensure compliance with regulations

Essential * BS and/or MS degree in science and 5 years of experience in Quality Assurance or related area * Prior audit and batch record review experience is required. * In-depth knowledge and experience with GMP and GLP regulations, and industry standards (USP, Ph.Eur., ICH, FDA, EU guidance) * Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software and internet search engines * Excellent written and verbal skills required * Must display strong analytical and problem-solving skills * Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. 

 Desirable * Experience within the Ophthalmology sector Rayner