Quality Assurance Shift Officer
Quality Assurance Shift Officer - County Waterford. Job Purpose: To support the Quality Assurance Manager and Quality Assurance Team Lead with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs. Core Responsibilities: To support the Quality Assurance Manager and Quality Assurance Team Lead with the quality assurance function. Support manufacturing areas with QA support including but not limited to the following: a. Real time in situ batch documentation review. b. Real time assessment of manufacturing events from a QA perspective. c. Provide clearance to precede instructions in manufacturing following unplanned events. Electronic Documentation Management System: a. Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation. b. Print hard copy managed print documents such as BMR’s. c. QA reviewer of Process Compliance Change Controls. d. Progress process compliance actions and attach evidence as required. Perform internal audits as scheduled with specific responsibility for the manufacturing areas. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. Report any safety or compliance issues. Prepare and review batch packs for QA/ QP release as per procedure. Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met. Assist with review of Submission Documentation in support of license applications and customer requirements. Non-compliance reporting and corrective action / continuous improvement implementation. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. To assist in the preparation for customer/ regulatory inspections. Attend a number of cross-functional team meetings as a Quality Assurance representative. Compile and deliver quality based training with the company. Minimum Qualifications & Experience sought: A third level degree incorporating Quality Assurance/ management (A standalone Quality Assurance or Quality management module may also fill this requirement. Graduate with at least 2 years' experience in a Pharma role / GMP related role. Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential. Excellent communication and presentation skills. Focus on quality and detail. Experience performing and assessing risk/impact assessment an advantage. This job originally appeared on RecruitIreland.com.
71 days ago