
Sterile Injectable Manufacturing Specialist
4 days ago
Seeking a Quality Assurance Professional with Sterile Injectable Manufacturing Expertise
Job Description:As a key member of our team, you will be responsible for ensuring the quality and integrity of sterile injectable manufacturing processes.
- Review and approve batch records to ensure completeness, accuracy, and compliance with regulatory requirements.
- Coordinate with cross-functional teams to resolve discrepancies and ensure timely documentation.
- Review electronic data for trends and recurring issues.
Key Responsibilities:
- Verify product label templates for accuracy against specifications and regulatory standards.
- Compile and review electronic data for Annual Product Quality Review (APQR) reports.
- Assess and approve change control proposals via QMS software.
Required Skills and Qualifications:
- 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.
Benefits:
- Opportunity to work with a dynamic team in a fast-paced environment.
- Chance to develop expertise in sterile injectable manufacturing and quality assurance.
Others:
- Participate in virtual inspections and audits.
- Provide remote guidance to manufacturing site teams.
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