Quality Assurance Specialist
1 week ago
As a key member of our quality team, you will play a critical role in ensuring the compliance and efficiency of our manufacturing processes. Your expertise will be instrumental in driving excellence across our organization.
- Review and approve batch records to ensure completeness, accuracy, and regulatory compliance.
- Coordinate with teams to resolve discrepancies or missing documentation.
- Verify product label templates for accuracy against specifications and regulatory standards.
- Compile and review electronic data for APQR reports.
- Approve CAPA plans in the QMS system.
- Review deviation reports and root cause analyses.
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.
This role offers a challenging and dynamic work environment with opportunities for growth and development.
What We OfferOur company offers a competitive salary, comprehensive benefits package, and a chance to make a real impact in the industry.
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