QA Validation
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| Job Type | Contractor |
| Location | Westmeath |
| Area | RoscommonWestmeath |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2467 |
| Job Views | 223 |
- Description
- QA Validation Specialist – Team Horizon
We are seeking applications for an experienced QA Validation Specialist (12-month contract) for our client, who are a leading biopharmaceutical company. In this role you will perform review and approval activities in the client’s cGMP commercial and clinical requirements for their manufacturing facility.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
Maintenance of a strong Quality culture throughout the project through operational activities.
Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations.
Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
Ensure and participate in the Quality Assurance support to internal manufacturing and technical groups. Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report, and protocols).
Authoring, review, and approval of QA validation -related procedures.
Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).
Support the vendor quality management programme.
Complete Audits as required.
Develop and report quality metrics for validation/verification.
Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
What you need to apply:
Degree in Science or similar discipline
Post-graduate studies as appropriate to augment primary degree is desired
3-5 years’ experience in Quality/validation environment.
Drug Product and Drug Substance experience
Excellent attention to detail
Good communication, teamwork and problem-solving skills
