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Quality Assurance Analyst
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Quality Assurance Manager
2 months ago
The Position:
This position is Quality Assurance Manager within the Quality group of a CMO.
SUMMARY:
The Quality Assurance manager is a key role for upholding the organization’s commitment to quality and compliance. Acts as a custodian of cGMP compliance and Regulatory. Promotes high quality standard to ensure Client is compliant with all regulatory agencies guidance and regulations including the US FDA, international pharmaceutical regulatory agencies, and State authorities.
PRINCIPLE RESPONSIBILITIES:
Creates and implements and maintains company high quality standard.
Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
Maintains and improves product quality by completing product, company, quality system, and compliance audits.
This role drives the classic QA activities with external and internal partners: Audits, deviations, OOS, change controls system, Quality management System, quality agreements, and Vendors qualifications.
QUALIFICATION:
Bachelor’s Degree in the life sciences or equivalent, with 10+ years of QA experience according to GMP at a biotech/pharma organization.
A passion for CMO management and product quality.
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