QA Manufacturing Operations Specialist (contract) - Dublin
|Job Title:||QA Manufacturing Operations Specialist (contract) - Dublin|
|Location:||Dublin, Republic of Ireland|
|Contact Name:||Nathan Wilson|
|Job Published:||August 18, 2017 08:57|
- QA support of manufacturing operations through start-up and onto routine commercial operations
- Implementation of batch record review process and on the-floor support of manufacturing activities
- QA Operations review of events and investigations
- Authoring, review and approval of QA-related procedures
- Review and approval of functional area documentation
- Support the Disposition process for Drug Substance and ensure material availability for Manufacturing through release of raw materials and consumables
- Participation in GMP reviews for new facility construction and new equipment support systems
- QA support for implementation of Manufacturing Execution System (MES) and development of batch records
- QA support for implementation of the Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function
- Change control assessment and CAPA evaluation/CAPA close-out
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
- Support OPEX programs and champion continuous quality improvement initiatives
- Hold a BSc in Science or related discipline, with minimum 3 years' QA or related experience in a Pharmaceutical environment.
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
- The QA Specialist will be required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work.
- The candidate must be able to work across a team matrix in order to meet accelerated timelines.
- Excellent communication & presentation skills are essential.
The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.
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