Cache of job #13805694

Job Title

QA Manager

Employer

FRS Recruitment

Location

Waterford

Description

FRS Recruitment are currently seeking a QA Manager to work for our client, a Pharmaceutical Products and Medical Devices manufacturer located in Waterford! The role of QA Manager: Responsible for facility compliance with regulatory commitments, in-house requirements and GMP in regards to computerized systems. Development of quality systems for Computer systems and support departments (IM&T, Engineering Development. Preparation of procedures and policies for area of responsibility. Investigation of software related deviations as part of quality team. Prioritizing SQA workload. Responsible for SQA review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, Change Controls. Manage the Software Non Conformance process Manage the software corrective action process, perform root cause investigations, develop CAPA plans and lead software related CAPA's. Manage software process improvement initiatives. Organize and deliver training in System procedures for required personnel. Lead and participate in risk management activities e.g. FMEA's. Participate in the site internal audit programme. Validation Activities. Provision of support and assistance in execution and control of Computerised System Validation programs. Manage validation policies. Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities. Development of protocols, test scripts and associated support documentation Perform the execution of software related protocols. Responsible for managing the Corrective Action process in regards to individual validations to ensure follow-up and effective resolution. What you need to have to apply: 3rd level qualification in software or computer related discipline. Qualified lead auditor. Project management desirable. Ability to evaluate and assess information to determine appropriate risk and required actions is critical. Training skills are essential, with ability to lead and motivate a team. Ability to influence individuals and groups. Good communication skills - written and oral. Organizational skills are essential. Ability to identify improvement needs. Attention to detail is essential. At least 5 years' experience in a similar role in a GMP regulated environment. At least 4 years supervisory/management experience. Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc. If you feel that you meet the above criteria please apply below or contact me directly! KEYWORDS: QA Manager, QA, Waterford, Irish Jobs, management, supervisor, Tester, Test Analyst, This job originally appeared on RecruitIreland.com.

Date Added

2382 days ago

Apply