- 経験
- 最長2歳
- 給料
- —
- 求人情報
- 1
- 投稿済み
- 4時間前
- 作業モード
- 在宅勤務
- 再開する
- 応募必須
仕事内容
Overview
We invite applications for a Quality Engineer position designed for recent graduates or candidates with limited experience to contribute to quality assurance, compliance, and continuous improvement within regulated pharmaceutical or life sciences sectors. The role supports key quality systems and ensures adherence to industry standards.
Primary Responsibilities
- Assist in implementing and maintaining Quality Management Systems (QMS).
- Ensure adherence to Good Manufacturing Practices and internal company standards.
- Support deviation management, including investigation and root cause analysis.
- Engage in Corrective and Preventive Actions (CAPA) processes.
- Review batch manufacturing documentation and other quality records.
- Provide support during regulatory and customer audits, both internal and external.
- Collaborate closely with production, quality control, and research & development teams.
- Contribute to process validation and qualification documentation efforts.
- Maintain accurate documentation consistent with Good Documentation Practices.
- Monitor and analyze quality metrics such as deviations and complaints.
Skills and Knowledge
- Foundational knowledge of Quality Management Systems.
- Understanding of regulatory frameworks, including 21 CFR Part 11, is advantageous.
- Familiarity with deviation control, CAPA activities, and change management.
- Strong analytical thinking and problem-solving capabilities.
- Effective documentation and communication proficiency.
- Competent with Microsoft Office applications including Excel and Word.