Lead - IPQA Quality

Role & responsibilities

An IPQA (In-Process Quality Assurance) Lead is responsible for overseeing and guiding the IPQA team to ensure all manufacturing and packaging operations comply with cGMP and regulatory standards.

Preferred candidate profile

Core responsibilities

• Supervision and leadership:

  Lead and guide the IPQA team to ensure all in-process quality activities are performed correctly and efficiently.

• Process monitoring:

  Conduct real-time monitoring of manufacturing and packaging processes to ensure compliance with standard operating procedures (SOPs) and Good Manufacturing Practices (GMP).

• Documentation and review:

  Review and approve batch manufacturing and packing records, logbooks, and other relevant documentation.

• Line clearance:

  Ensure proper line clearance is conducted before manufacturing and packaging to prevent cross-contamination and mix-ups.

• Quality checks:

  Monitor critical process parameters and perform in-process checks to ensure product quality.

• Deviation and CAPA management:

  Lead or support investigations for deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results. Ensure timely closure of Corrective and Preventive Actions (CAPA).

• Compliance and audits:

  Ensure readiness for regulatory and customer audits by maintaining GMP documentation and compliance.

• Training:

  Train manufacturing and quality staff on GMP, GDP, and IPQA procedures.

Key skills and qualifications

• Education:

  Master's in Pharmacy is preferable

• Experience:

  Minimum 20 years experience in pharmaceutical manufacturing and In process Quality Assurance in INJECTABLE Mfg is must

• Regulatory knowledge:

  A strong understanding of industry regulations, especially GMP guidelines, is critical.

• Soft skills:

  Strong communication, leadership, and problem-solving skills are necessary to effectively lead the team and interact with other departments.