QA Sterilization
Vue: 103
Jour de mise à jour: 02-12-2025
Catégorie: Assurance Qualité / Contrôle Qualité
Industrie: Pharmaceutical Manufacturing
Niveau: Entry level
Type d’emploi: Full-time
le contenu du travail
Job Description: QA Sterilization SpecialistWe are seeking a dedicated QA Sterilization Specialist to join our team within a GMP-compliant pharmaceutical company. The ideal candidate will have a strong background in sterilization processes and quality assurance, ensuring that all sterilization activities meet stringent regulatory and quality standards.
- Sterilization Process Oversight: Oversee and monitor sterilization processes to ensure compliance with GMP regulations and company standards.
- Validation and Qualification: Develop, implement, and manage validation and qualification protocols for sterilization equipment and processes, including autoclaves, dry heat ovens, and other sterilization methods.
- Documentation and Reporting: Prepare and maintain comprehensive documentation for all sterilization activities, including validation reports, batch records, and deviation reports. Ensure all records are accurate and up-to-date.
- Quality Assurance: Perform routine audits and inspections of sterilization processes to identify and address any potential quality issues. Ensure that all sterilization activities adhere to cGMP, regulatory, and internal standards.
- Training and Compliance: Provide training and support to staff on sterilization procedures and quality standards. Stay current with industry regulations and best practices, and ensure the team is informed of any changes.
- Problem-Solving and Continuous Improvement: Investigate and resolve any issues related to sterilization processes. Implement continuous improvement initiatives to enhance process efficiency and product quality.
- Technical Expertise: In-depth knowledge of sterilization methods and technologies, including steam, dry heat, and chemical sterilization.
- Regulatory Knowledge: Strong understanding of GMP regulations and quality standards applicable to sterilization processes.
- Analytical Skills: Ability to analyze and interpret data related to sterilization processes and make informed decisions.
- Attention to Detail: Meticulous attention to detail in documentation and process monitoring to ensure compliance and quality.
- Communication and Training: Excellent communication skills, with the ability to train and support staff on sterilization procedures and quality standards.
- Experience: Minimum of 3 years of experience in a QA role within a GMP-compliant environment, with a focus on sterilization processes.
If you are passionate about quality assurance and have a strong background in sterilization processes within the pharmaceutical industry, we invite you to apply.
Please submit your CV and a cover letter highlighting your relevant experience and skills.
Date limite: 16-01-2026
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