Unit Head QA

Job Description

Interested candidates are requested to share their resumes at Neha.More1@cipla.com . Job Purpose : Control and implement the Quality functions within the organization to ensure that the final product is as per the desired safety, quality, identity, integrity, purity and is safe for human use. Position Overview: Responsible for ensuring the quality assurance processes align with the production plan and regulatory requirements, while coordinating with cross-functional teams for the successful release of materials and products. Key Responsibilities: Meeting Coordination: Organize stakeholder meetings to prioritize tasks based on the production plan. Testing Coordination: Collaborate with QC for testing and release of incoming materials and finished products. Validation Planning: Plan and review validation/qualification activities for processes and equipment. Quality Improvement: Evaluate areas for improvement within quality assurance to support the production plan. Documentation Management: Review and approve key documents (Gap Analysis, BMR, etc.) and certificates of analysis. Monitor batch documentation and SAP entries for compliance. Regulatory Engagement: Ensure timely responses to regulatory communications and oversee monitoring activities. CAPA Management: Review root causes, approve CAPAs, and assess their effectiveness through post-implementation reviews. Risk Management: Coordinate quality risk management efforts and monitor KPIs to gauge unit health. Continuous Improvement: Review and approve action plans for SOPs, specifications, and test methods. Management Review: Conduct quality management reviews and escalate findings to site leadership. Safety Oversight: Review safety systems and coordinate with the HSE department to track incidents and ensure compliance with safety training.