Talent Destination
Website:
talent-destination.com
Job details:
Job Summary
We are seeking an experienced Site Quality Head to lead the Quality function of our API manufacturing facility. The incumbent will be responsible for ensuring compliance with cGMP and global regulatory standards, driving quality excellence, and maintaining a robust Pharmaceutical Quality System (PQS). The role requires strong leadership in Quality Assurance, Quality Control, Validation, and Regulatory Compliance while ensuring continuous inspection readiness.
Key Responsibilities:
- Lead and oversee the overall Quality function, including QA, QC, Validation, Documentation, and Quality Systems.
- Ensure compliance with cGMP, ICH guidelines, WHO-GMP, US FDA, EU GMP, CDSCO, and other applicable regulatory requirements.
- Maintain and continuously improve the Pharmaceutical Quality System (PQS).
- Review and approve critical quality documents, including SOPs, Site Master File (SMF), Master Batch Records (MBR), Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Change Controls, Deviations, OOS/OOT investigations, and CAPAs.
- Ensure timely batch review, product disposition, and release in accordance with regulatory and company requirements.
- Lead Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification, and Analytical Method Validation programs.
- Drive Data Integrity compliance in line with ALCOA+ principles across all quality systems.
- Lead and manage regulatory inspections, customer audits, corporate audits, and self-inspections, ensuring timely closure of observations.
- Establish and monitor quality KPIs and drive continuous improvement initiatives.
- Lead supplier qualification, quality risk management, and product quality review programs.
Required Skills & Competencies
- Strong knowledge of cGMP, ICH Guidelines, WHO-GMP, US FDA, EU GMP, and Data Integrity (ALCOA+).
- Proven experience in managing regulatory inspections and customer audits.
- Expertise in Quality Systems, Validation, Risk Management, Investigations, and CAPA.
- Strong leadership, decision-making, communication, and stakeholder management skills.
- Excellent problem-solving, analytical, and strategic planning abilities.
Click on Apply to know more.
