QA Specialist - Systems & Compliance - Pharmaceutical
- Dublin
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Biopharmaceutical manufacturing plant have a contract requirement for a QA specialist to join the Quality systems & compliance team.
You will will provide QA oversight and support qualification, technical transfers, regulatory approvals and commercial operations. The role will support the biologics Drug Substance manufacturing operations and will be responsible for release testing and batch certification for finished drug product.
Responsibilities will include (but not limited to):
- Support Material disposition of raw materials and consumables for the site
- Support the Supplier Quality Management program.
- Support the Material Qualification program.
- Support the administration of Product Quality Complaints (PQC) including processing, and maintenance of site PQC program.
- Support the QA Documentation systems on site.
- Support the administration of Change Control system.
- Support and maintain the Quality Risk Management program.
- Support of Regulatory and Corporate Inspections and achievement of market approvals.
- Co-ordination and support of the CAPA system, Global Regulatory Observation Evaluations.
- Participates in the Site Self-Inspection Program by conducting audits of site functions.
- Interface with the relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
- Authoring, review and approval of QA-related procedures.
- Support Quality Council and Quality Site Metrics generation.
- Support OPEX programs and champion continuous quality improvement initiatives.
Qualifications and Experience required:
- The successful candidate will hold a BSc in Science or related discipline
- 3 years’ QA experience in a bio-pharmaceutical environment.
- A clear understanding of cGMP requirements for quality systems and compliance is required
- The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential
Call me for further information on this role!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
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
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
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
Save as job alert
Similar Jobs
Salary
Competitive
Location
Dublin
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Dublin
Description
QC Lab Systems Engineer - Life Science - Dublin - 12-Month Contract Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives?
Reference
32560
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonSalary
Competitive
Location
Cork
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Cork
Description
Quality Systems Specialist - Cork, Ireland - 11-Month Contract One of our global Pharmaceutical clients is looking for a Quality Systems Specialist to join their team close to the picturesque and
Reference
33962
Expiry Date
01/01/0001
Author
Jack SteadmanAuthor
Jack SteadmanSalary
Competitive
Location
Vlissingen
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Rotterdam
Description
Civil QC Inspector - Energy - Rotterdam (South) - 12-Month Contract+ Are you a Civil QC Inspector looking for your next contract? We are working with a world leader in solutions for offshore
Reference
33246
Expiry Date
01/01/0001
Author
Brandon SalesAuthor
Brandon SalesInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Wendy
I manage this role.