Sterile Drug QA Associate: Start-up & Compliance

PSC Biotech Corporation; Cork; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

PSC Biotech Corporation is seeking an experienced QA professional to support the start-up and ongoing QA of sterile drug product filling operations in Cork, Ireland. The role reports to the QA Operations Manager and requires hands-on quality leadership across technical transfers, change controls and GMP documentation.

The ideal candidate has 5+ years in pharmaceutical/biotech QA, strong knowledge of FDA/EMEA standards, and proven ability to drive CAPAs and deviations while promoting continuous

Qualifikationen

• Required: Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Required: Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Required: Relevant experience (5+ yrs) in a Quality function in pharmaceutical/biotech industry or equivalent.
• Required: Knowledge of FDA/EMEA regulations/standards and quality systems.
• Required: Proficiency in PC skills such as Excel, Word, PowerPoint.
• Required: Strong written and verbal communication skills.

Aufgaben

• Provide Quality direction and oversight of start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring clear scope of records and timely implementation.
• Write, review and approve SOPs, Work Instructions, MTAs, Master Batch Records, Specifications and other GMP documentation.
• Participate in cross-functional project teams to address issues in real time to meet timelines.
• Lead tasks to ensure critical activities are completed on time and to requirements.
• Provide Quality input to Deviations and CAPAs for timely closure with robust documentation.
• Support pre-approval regulatory inspection readiness for approvals.
• Assist with Quality Assurance elements needed for new product launches.

Kenntnisse

Sterile Drug Filling

Quality function experience

FDA/EMEA knowledge

Root Cause Analysis

Validation knowledge/experience

Lean / Continuous Improvement

MS Office (Excel/Word/PowerPoint)

Ausbildung

Degree in Science/Quality

Jobbeschreibung

PSC Biotech Corporation is seeking an experienced QA professional to support the start-up and ongoing QA of sterile drug product filling operations in Cork, Ireland. The role reports to the QA Operations Manager and requires hands-on quality leadership across technical transfers, change controls and GMP documentation.

The ideal candidate has 5+ years in pharmaceutical/biotech QA, strong knowledge of FDA/EMEA standards, and proven ability to drive CAPAs and deviations while promoting continuous