QA Specialist

CPL

Westmeath

Overall Purpose: You will be a key part of the Quality team ensuring the site has a strong compliance and knowledge pharmaceutical base which is aligned with the principles and expectations of the current Good Manufacturing Practice (cGMP) regulations. This role will ensure that the site establishes and maintains the procedures and specifications that affect the quality of Aerie’s products. They will also provide support and a knowledge base in all aspects of cGMP in relation to Deviation, CAPA, Change control and Audit Support. Essential Duties, Functions and Responsibilities: Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Manages the Change Request System, Deviation System, CAPA System and provide Monthly KPI on such. Assist in the management of Customer Quality Complaints & Pharmacovigilance systems. Perform detailed batch record review of finished products prior to / for QP release. Assist in the management of the routine commercial stability program. Prepare annual product quality review reports. Assist in the maintenance of the company incoming inspection program. Assist in the management of the internal, vendor and regulatory audit program including the performance of audits as required. Maintain & control QA documentation issue numbering indices, databases, and control logs. Prepare monthly/quarterly/annual KPI/Management review data. Issuance of batch record paperwork to the relevant manufacturing responsible and to manage issuing, distribution and withdrawal of SOPs and associated documents. Supports the maintenance of the Document Control system and issuance of monthly document control metrics. Provides additional support and assistance on tasks and projects as directed by management. Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues. Experience required for the role: Minimum 3 years experience in a QA role. Experience in managing a Deviation, CAPA and Change Request System within a manufacturing enviornment. Experience in a regulated GMP environment (ideally sterile. Experience in batch record review. Technical problem solving. Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations. Education Required : Degree in a Science or Engineering related discipline. Contact Rebecca Brown on 01-9476212 or 087-7089779 for more information. #LI-RB1. This job originally appeared on RecruitIreland.com.

2038 days ago