QA Specialist
at Asset Recruitment
Dunboyne, County Meath, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 26 Jul, 2024 | Not Specified | 05 May, 2024 | 4 year(s) or above | Qrm,Technical Operations,Sap,Pharmaceutical Industry,Biologics,Deviations,Delta V,Pharmaceuticals,Regulatory Agencies,Veeva | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
REQUIREMENTS
- Bachelor’s degree, or higher in Science, Quality or Technical.
- Min 4-5 years’ experience, preferably in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
- Prior experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
- Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
- Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
- Direct experience in interacting with regulatory agencies during site inspection desirable.
- Strong attention to detail and precision in preparing and reviewing GMP documentation.
- Previous experience working in a sterile/low bioburden environment desirable.
Responsibilities:
- Daily participation on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
- Lead and participate in investigation of deviations, risk assessments and changes, ensuring the correct actions are implemented timely.
- Provide oversight for GMP readiness, regulatory approvals, technical transfers and clinical operations at the facility.
- Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required.
- Contribute in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements.
- Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
- Prompt escalate compliance risks to management when necessary.
REQUIREMENT SUMMARY
Min:4.0Max:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Software Testing, Clinical Pharmacy
Graduate
Science quality or technical
Proficient
1
Dunboyne, County Meath, Ireland