- QA support of manufacturing operations through commercial operations and any new product introductions.
- 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.
- QA support for the development of batch records.
- 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.
As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking a QA Specialist to become part of a $500 million state of the art bio facility. Located 15 minutes from Dublin
As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking Quality Specialist to become part of a $500 million state of the art bio facility. Located 15 minutes from
Republic of Ireland
An exciting new opportunity with a global biotech company has arisen. They need an downstream manufacturing technology scientist / engineer for an initial 12 month contract working on the new product
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