Sr.Executive/Asst.Manager- Quality Control @ Kazipalli

Role & responsibilities

1. Quality Management System :

• Implement and maintain QC-related quality management systems in compliance with cGMP and regulatory requirements.
• Coordinate the preparation, review, and implementation of SOPs, specifications, protocols, and other controlled documents.
• Monitor deviations, CAPA, change controls, and laboratory incidents, ensuring timely investigation and closure.
• Maintain QMS records and ensure compliance with established procedures.

2. Learning Management System :

• Coordinate QC personnel training activities through the LMS.
• Ensure timely completion of assigned GMP, SOP, safety, and job-specific training.
• Maintain training records and monitor overdue training activities.
• Coordinate with departmental heads and QA to ensure training compliance and audit readiness.

3. Report Drafting and Documentation:

• Prepare, review, and compile analytical reports, investigation reports, trend reports, and other QC-related documents.
• Review laboratory records, analytical worksheets, and supporting data for accuracy, completeness, and traceability.
• Ensure documentation complies with ALCOA+ data integrity principles and applicable documentation practices.
• Support the preparation of technical documents and responses for internal, customer, and regulatory audits.

4. OOS and Laboratory Investigations:

• Coordinate and conduct OOS investigations in accordance with approved SOPs and regulatory expectations.
• Perform initial laboratory assessments and support comprehensive investigations to identify root causes.
• Investigate laboratory errors, atypical results, deviations, and other quality-related incidents.
• Coordinate with QC analysts, QA, Production, and other stakeholders to establish root causes and implement CAPA.
• Ensure investigations are scientifically justified, adequately documented, and closed within defined timelines.
• Support OOT (Out-of-Trend) investigations, where applicable.