- Quality Systems & Compliance
- Learn, implement, and ensure adherence to cGMP and QMS requirements.
- Ensure SOP compliance on the shop floor and across manufacturing processes.
- Manage QMS documentation, deviations, change controls, and CAPA.
- Maintain Master Samples and Control Samples as per FDA requirements.
- Audit & Regulatory Support
- Support internal, customer, and regulatory audits.
- Prepare and manage audit responses, ensure timely closure of audit observations.
- Understand and support implementation of regulatory requirements applicable to capsule manufacturing.
- Batch Review & Release
- Review Batch Manufacturing Records (BMRs) for compliance and accuracy.
- Support batch release activities and conduct investigations based on BMR findings.
- Monitor and ensure CTQ (Critical to Quality) compliance.
- Quality & Validation (Q&V)
- Learn and execute Qualification & Validation (Q&V) of equipment, utilities, and processes.
- Support Q&V activities for new projects, including automation and digitization initiatives.
- Conduct risk assessments for Q&V and OpEx improvement projects.
- Incoming Quality Control (IQC)
- Monitor and analyze IQC activities for raw materials.
- Plan, allocate, review, and release Raw Material (RM) analysis.
- Ensure compliance with quality standards for incoming materials.
- Microbiology & Utilities Monitoring
- Learn, monitor, and analyze microbial load in:
- Environment
- Raw Materials
- In-process and Finished Products
- Monitor and review HVAC and Water Systems for compliance and performance.
- Customer Complaints & Investigations
- Handle customer complaints, conduct detailed investigations.
- Perform Root Cause Analysis (RCA) and implement CAPA.
- Track effectiveness and ensure closure of complaint-related actions.
- Data Monitoring & Process Review
- Monitor, analyze, and review dimensional data and manufacturing process parameters.
- Support continuous improvement initiatives through OpEx, automation, and digitization projects.
Any other additional responsibility can be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.
- Key Result Areas
- cGMP & QMS Compliance
- Batch Review & Release
- Audit Readiness & Audit Management
- Qualification & Validation (Q&V)
- Incoming Quality Control (IQC)
- Microbiology & Utilities Monitoring
- Customer Complaint Handling
- SOP Compliance & Shop Floor Quality
- OpEx, Automation & Digitization
