Cache of job #13852159

Job Title

Quality Manager - Pharma

Employer

Brightwater

Location

Tipperary, Waterford

Description

A key client is seeking an experienced Quality professional for a hand's on role managing a small QA department at their Pharma facility. A strong overall quality background is required as this position will encompass systems development and management, deviartions and CAPA, audit readiness and hosting as well as supervision and leadership of a team. Principle duties: To manage the compliance within the dept. and ensure that the area is operating in accordance to GLP. To provide support on any external investigations. To lead continuous improvement activities and support projects. Assist in any validation activities that may as the Quality representative within the project. To oversee the product and process performance using appropriate metrics Quality representative on the sign off of change controls, documentation and validation activities. Lead projects for the introduction of new equipment within the site, ensuring that the correct level of validation is completed, that the relevant procedures are updated, and that there is a training plan in place. To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product. To ensure that the procedures are up to date and in compliance to the global systems. To ensure that the records generated are accurate and completed in real time. To review method validation protocols and reports on new/ existing test methods, as required. To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product. Requirements: Experience of scientific report writing including such documents, protocols, deviations, reports etc. Have managed a QA department for 5 years in Pharmaceuticals. Ability to evaluate and assess information to determine appropriate and required actions is critical. Good knowledge of Tablet manufacturing desirable. Knowledge of purified water and Environmental Monitoring systems. Full understanding of the requirements of the Regulatory Standards. Degree in chemistry, science or related technical discipline. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

Date Added

2264 days ago

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