QA Specialist - Shift role
QA Specialist required to join a Global biotech company located in Dublin for an initial 12 month contract based on a 24 / 7 shift rota.
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Reporting to the QA Operations Manager, the QA Specialist will provide QA oversight and support construction, qualification and validation, technical transfers, regulatory approvals and commercial operations. The role will also support the biologics Drug Substance manufacturing operations through start-up and onto routine commercial operations.
Key responsibilities of the “QA Manufacturing Operations Specialist” may include;
- 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 the 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.
- BSc in Science or related discipline with 2 years’ minimum QA or related experience in a pharmaceutical environment.
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines.
- Excellent communication & presentation skills are essential.
- Excellent time management & organisational skills along with a proven ability to multi-task.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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Republic of Ireland
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