CQA HEAD |

Job Description : CQA HEAD | PHARMA SYDNEY AUSTRALIA Open to International candidates ???? Experience: 25+ Years ???? Salary: Up to AUD 240 K Only Oncology + Sterile background candidates are eligible. Minimum 3 years of current experience as CQA Head is mandatory. Strong exposure to Regulatory Audits, Compliance & Inspection Readiness is mandatory. Proven experience in handling USFDA / MHRA / EU-GMP / WHO-GMP or other regulatory inspections preferred. Candidate should have strong leadership experience in Sterile Oncology manufacturing operations and quality systems. ???? KEY RESPONSIBILITIES – CQA HEAD Provide strategic leadership for Corporate Quality Assurance / Site Quality Assurance functions across Oncology Sterile operations. Ensure complete compliance with cGMP, regulatory requirements, Quality Management Systems and internal quality standards. Lead and manage regulatory audits, customer audits and health authority inspections, including inspection readiness and remediation. Oversee deviations, CAPA, Change Control, OOS/OOT, Quality Risk Management and investigations. Ensure effective implementation and continuous improvement of QMS and Data Integrity systems. Drive product quality, patient safety, compliance culture and continual quality improvement. Review and approve critical quality documents, SOPs, protocols, reports and regulatory responses. Lead PQR/APQR, validation/qualification, process validation and quality risk assessment activities. Coordinate with Production, QC, Engineering, Regulatory Affairs and R&D for effective quality governance. Develop, mentor and lead a high-performing QA/CQA team. Ensure timely closure of audit observations, CAPA commitments and regulatory commitments. Act as the key quality leader for Oncology Sterile manufacturing and aseptic operations.

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