Quality Lead

1. In-Process Quality & Manufacturing Monitoring

• Monitor, analyze, and review in-process quality control checks across manufacturing operations.
• Monitor and trend dimensional data and manufacturing process parameters.
• Support data-driven decision-making based on machine capability and customer profiles.

2. Product, Process & Customer Understanding

• Develop strong understanding of product and process requirements from a customer perspective.
• Identify and monitor CTQ (Critical to Quality) parameters.
• Prepare CTQ reports and support corrective actions where required.

3. Incoming Quality Control (IQC)

• Understand and support IQC functioning, including roles of Operators, Supervisors, and IQC Head.
• Plan, allocate, review, and release raw material analysis.
• Ensure compliance of incoming materials with defined quality standards.

4. Batch Review, Release & Investigation

• Review Batch Manufacturing Records (BMRs) for compliance and completeness.
• Support batch release activities.
• Conduct investigations based on BMR findings and implement corrective actions.

5. Customer Complaints & Investigations

• Analyze customer complaints related to product quality.
• Perform Root Cause Analysis (RCA) and implement CAPA.
• Ensure timely closure and effectiveness of corrective actions.

6. cGMP, QMS & SOP Compliance

• Learn, implement, and ensure adherence to cGMP and QMS requirements.
• Ensure SOP compliance on the shop floor.
• Support documentation and audit readiness activities.

7. Qualification, Validation & Utilities (Basic)

• Learn and support Qualification & Validation (Q&V) activities for equipment and systems.
• Gain exposure to utilities and water systems impacting product quality.
• Support validation documentation and compliance.

8. Automation, Digitization & OpEx

• Participate in automation and digitization projects, focusing on product quality-impacting parameters.
• Support OpEx improvement initiatives to enhance quality, efficiency, and compliance.

9. Microbial Monitoring (Basic Exposure)

• Learn and support monitoring of microbiological load in environment and product (basic level).
• Coordinate with QC / Microbiology teams as required.