
Sterile Injectable Manufacturing Professional
1 week ago
The Quality Assurance Specialist will ensure the integrity of our manufacturing processes.
- Key Responsibilities:
- Prepare, review and approve validation protocols and reports for media fill studies to ensure aseptic process integrity.
- Analyze remote media fill results, identify deficiencies and recommend corrective or preventive actions.
- Develop and maintain area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data.
- Prepare and review periodic requalification protocols, data and environmental monitoring summaries for compliance with regulatory requirements.
- Support and participate in Factory Acceptance Test execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
- Develop and review utility qualification documentation, including HVAC, Water for Injection and compressed air system validation.
- Prepare, review and approve cleaning validation protocols and reports to ensure adequacy, compliance and suitability for product changeover.
- Maintain and update the Validation Master Plan, ensuring alignment with regulatory expectations and site needs.
Requirements:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology or related field.
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
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