QA Specialist
- Dublin
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
- 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.
Requirements:
- 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.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Caroline
I manage this role.