- 经验
- 5年以上
- 薪水
- —
- 职位空缺
- 1
- 发布
- 5天前
- 工作模式
- 在办公室
- 学历
- Relevant life sciences degree
- 合格
- Candidates must have the legal right to work in Ireland.
- 恢复
- 需要申请
职位描述
Role overview
An Ireland-based biotechnology organization is hiring a QC Specialist to support quality control activities for plasmid and gene therapy product manufacture and release. The position sits within a GMP manufacturing environment and covers equipment qualification, transfer of analytical methods, in-process and final release testing, plus wider QC support work.
Key focus areas
- Support and help lead the transfer of analytical methods into the QC function.
- Contribute to implementation of testing methods and related analytical activities.
- Take ownership of investigations, corrective and preventive actions, and GMP-related quality decisions.
- Assist with new product introduction and shape QC plans and strategy.
- Serve as a subject-matter resource in a technically demanding ATMP and gene therapy setting.
Candidate profile
The ideal applicant will bring a solid QC background in GMP-regulated environments, with preference for biologics or ATMP experience. The role requires practical analytical troubleshooting skills, familiarity with tech transfer and method validation, and the confidence to work independently while taking responsibility for outcomes.
Qualifications and experience
- A relevant degree in life sciences is required.
- At least 5 years of experience in the pharmaceutical or biotechnology sector is needed.
- Proven understanding of GMP-based quality control operations is essential.
- Experience working with audits and directly with clients is expected.
- Working knowledge of EU and FDA regulations, ICH guidance, GMP, GLP, GCP, Lean Manufacturing, and Six Sigma is required.
- Strong teamwork, communication, and conflict-resolution abilities are important.
Eligibility
Applicants must already have the right to work in Ireland.
Additional information
For further details, contact Timi Asseez. R&D Partners is a life sciences recruitment agency representing this vacancy on behalf of its client. Submission of an application confirms that you have read and understood the privacy policy governing personal data processing and protection.