Quality Assurance Officer

Collins Mcnicholas Recruitment

Waterford

Role Responsibilities: To support the Head of Quality and the R&D Quality Assurance Manager & Team Lead with the quality assurance function. Support R&D with QA support including but not limited to the following: batch documentation review. assessment of manufacturing events from a QA perspective. Electronic Documentation Management System Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation. QA reviewer of Process Compliance Change Controls. Progress Process Compliance actions and attach evidence as required. Perform internal audits as scheduled. Review and approval of Regulatory deficiency responses. 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 as per company procedures. Attend Product review meetings and provide support on the development of new Products. Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met. Assist with review of Submission Documentation in support of license applications and customer requirements. Noncompliance reporting and corrective action / continuous improvement implementation. Operation of SAP Quality function as per procedures. Support the on-going OOS/IR/CACI closeout programme. Complete any assigned actions in the agreed time frame. Investigate any incident assigned in a timely fashion. Review deviation investigations and actions as required. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Health & Safety Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs. Report any hazards. Minimum Qualifications and Experience: BSc (Require Quality Management as a part of degree. Minimum of 2 - 4 years QA experience in a GMP compliant 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. Careful planning to achieve accurate and timely results. Ability to define and manage own tasks and schedules. Experience performing and assessing risk/impact assessment an advantage. Sterile manufacturing experience would be of benefit. Skills & Behavioural Competencies: Skills: Demonstrates a high level of Technical understanding. Motivated. Drives continuous improvements. Ability to multi-task. Behaviours: Proficient at review of EudraLex chapters and CFR 21 parts 210 and 211. Leading investigations and OOS's. Leading GMP and Quality impacting training site wide. Experience with process and method validation review and equipment qualification. Implement and review Major change controls and associated Risk Assessments. Coordinate and lead customer complaint investigations. Lead auditor trained. Provide QA oversight to projects. Provide training to level 1 officers and interns. Risk assessments and regulatory compliance implementation and interpretation. Perform Gap Assessments between current procedures and related guidance's. Work to assigned goals. For a confidential discussionandmore information on the role,please contactRory Walshon 021 4911063or email rory.walsh@collinsmcnicholas.ie. For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos! This job originally appeared on RecruitIreland.com.

2081 days ago