Sterility Assurance Lead – Retrospective Review Expert

ProPharma Group; Raleigh (NC); Vor Ort; USD 96.000 - 138.000; Vollzeit

Zusammenfassung

ProPharma Group in Kansas City, KS (onsite) is seeking an experienced leader to head the retrospective product review workstream for a 2-3 month engagement. You will oversee methodology development, technical oversight, and client communications, coordinating a small review team to deliver high-quality assessments.

The role requires strong expertise in sterile manufacturing, aseptic processing, and FDA remediation, with a track record of delivering rigorous product impact analyses.

Qualifikationen

• 10 years of experience in sterile manufacturing and sterility assurance.
• Experience with aseptic processing and FDA remediation.
• Ability to develop review protocols and assess product impact.

Aufgaben

• Lead the retrospective product review workstream and oversee 2-3 person team.
• Serve as primary client contact and overall workstream lead.
• Develop and finalize the review protocol and assessment methodology.
• Coordinate execution of retrospective review and deliverables.
• Provide technical oversight of the review process.
• Perform secondary review of lot assessments and product impact assessments.
• Review technical conclusions for consistency and scientific rationale.
• Escalate significant product-quality concerns.
• Support preparation and finalization of interim reports and final deliverables.
• Participate in project governance meetings and status updates.

Kenntnisse

Sterile manufacturing

Sterility assurance

Aseptic processing

Product impact assessments

FDA remediation

Jobbeschreibung

ProPharma Group in Kansas City, KS (onsite) is seeking an experienced leader to head the retrospective product review workstream for a 2-3 month engagement. You will oversee methodology development, technical oversight, and client communications, coordinating a small review team to deliver high-quality assessments.

The role requires strong expertise in sterile manufacturing, aseptic processing, and FDA remediation, with a track record of delivering rigorous product impact analyses.