My client is a full GMP CMO facility for the manufacture of GMP intermediates, APIs and excipients located in Chicago metropolitan area.
SUMMARY:
The Quality Assurance Manager has a key role in upholding the organization’s commitment to quality and compliance. Acts as a custodian of cGMP compliance and Regulatory. Promotes high quality standards to ensure my clients are compliant with all regulatory agencies guidance and regulations including the US FDA, international pharmaceutical regulatory agencies, and State authorities.
PRINCIPLE RESPONSIBILTIES:
- Creates and implements and maintains company high quality standard
- Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
- Maintain 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 as well as filling with and responding to regulatory bodies, such as manage DMF, VMFs.
JOB DESCRIPTION
- Assists in the successful execution of customer and agency audits.
- Batch record review and approval as well as Quality Assurance support and documentation review and approval.
- Authority to approve, release, reject or hold raw materials, packaging and finished product along with labeling
Must have:
- Small molecule API experience
- Previous is Quality Assurance Manager with a CDO
- Onsite
- Location: Chicago, IL or Milwaukee WI (Or surrounding areas)
If you're passionate about upholding high-quality standards and ensuring compliance with FDA and international regulations, this could be the next big step in your career!