Lead QA Validation – Sterile GMP & Data Integrity

United Pharma; Missouri; Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

United Pharma seeks a seasoned Quality Assurance Validation SME to lead the QA validation function at a sterile injectable GMP site. You will provide expert guidance on equipment and utility qualification, process and cleaning validation, media fill activities, and CSV, ensuring regulatory alignment and data integrity.

You will review validation plans, risk assessments, and reports, while mentoring staff and supporting inspections by FDA/EMA.

Qualifikationen

• Bachelor’s or advanced degree in life sciences, engineering, or a related field.
• 8+ years GMP pharma manufacturing experience with QA validation oversight.
• Strong regulatory knowledge (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8–Q10; WHO, PIC/S).
• Expertise in sterile manufacturing validation (media fill, cleaning validation, facility qualification).
• Experience with computer system validation and data integrity controls.

Aufgaben

• Lead QA validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
• Review and approve validation master plans, protocols, reports, and risk assessments.
• Provide QA oversight for media fills and validation strategies for aseptic manufacturing.
• Oversee CSV deliverables under 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Champion ALCOA+ data integrity across validation docs.
• Collaborate with Engineering, Validation, Manufacturing, IT, and QC teams.

Kenntnisse

QA leadership

Validation oversight

GMP/regulatory knowledge

Documentation & data integrity

Cross-functional collaboration

Regulatory inspections

Ausbildung

Bachelor’s degree in life sciences/engineering

Jobbeschreibung

United Pharma seeks a seasoned Quality Assurance Validation SME to lead the QA validation function at a sterile injectable GMP site. You will provide expert guidance on equipment and utility qualification, process and cleaning validation, media fill activities, and CSV, ensuring regulatory alignment and data integrity.

You will review validation plans, risk assessments, and reports, while mentoring staff and supporting inspections by FDA/EMA.