- 経験
- 5～8歳
- 給料
- —
- 求人情報
- 1
- 投稿済み
- 6時間前
- 作業モード
- 在任中
- 教育
- Postgraduate in Microbiology or Biotechnology
- 再開する
- 応募必須
勤務地
仕事内容
Role Overview
This position requires an experienced microbiology professional responsible for quality control activities including sterility testing, validation, and equipment qualification within a pharmaceutical context.
Key Responsibilities
- Conduct sterility and Bacterial Endotoxin Testing (BET) on raw materials and finished products.
- Execute validation procedures including preparation and evaluation of SOPs, STPs, validation protocols, and detailed reports related to microbiology.
- Perform equipment qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requalification (RQ), and Process Validation (PV).
- Manage calibration tasks associated with microbiology instruments and equipment.
- Initiate and oversee Change Control processes, handle deviations, and coordinate Corrective and Preventive Actions (CAPA).
- Perform bioburden assessments for water, raw materials, and products to ensure microbial limits compliance.
- Carry out population determination tests of biological indicators.
- Conduct testing related to cell banks to maintain quality standards.
Experience and Education
- Experience: 5 to 8 years in relevant microbiology roles.
- Educational Qualification: Postgraduate degree in Microbiology or Biotechnology.
Desired Competencies
- Innovation and creativity in problem solving.
- Strong focus on results and outcome orientation.
- Effective collaboration and teamwork.
- Customer-centric mindset.
- Ability to develop talent within teams.
- Strong stakeholder management skills.
- Strategic agility to adapt to evolving processes.
- Commitment to process excellence and quality standards.