Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary:
We are seeking a knowledgeable and dedicated Microbiology Specialist to join our team.
The ideal candidate will play a crucial role in maintaining the quality and safety of our products through rigorous microbiological analysis and quality assurance.
Key Responsibilities:
- Conduct microbiological testing of raw materials, in-process samples, finished products, and stability samples in accordance with applicable regulatory requirements and internal quality standards.
- Develop, validate, optimize, and implement microbiological testing methods, ensuring compliance with GMP, pharmacopeial requirements, and quality assurance procedures.
- Perform environmental monitoring activities within production areas and laboratories, analyze data trends, investigate excursions, and support compliance with microbiological standards.
- Investigate microbiological product complaints, deviations, out-of-specification (OOS) results, contamination events, and sterility failures, providing comprehensive reports, root cause analyses, and corrective and preventive action (CAPA) recommendations.
- Review microbiological test results, protocols, reports, and laboratory documentation to ensure accuracy, compliance, and data integrity.
- Provide technical support and guidance to junior team members and contribute to knowledge sharing within the microbiology function.
- Collaborate with Quality Assurance, Production, Validation, and Engineering teams to support product quality, process improvements, and regulatory compliance.
- Support and contribute to continuous improvement initiatives related to microbiological testing, laboratory operations, and contamination control practices.
Requirements
- Master's or Bachelor's degree in Science, or a related field.
- 2-3 years of experience in microbiology within the pharmaceutical, biotechnology, or related industries
- Strong analytical skills with proficiency in laboratory techniques and equipment.
- Detail-oriented with a commitment to accuracy and compliance.
- Excellent communication and interpersonal skills.