We are looking for a dedicated QA Manufacturing Lead to be our quality champion on the manufacturing shop floor. In this role, you will play a critical part in maintaining Good Manufacturing Practices (GMPs), ensuring that every product meets our rigorous quality standards.
Your responsibilites will include,
1. Real-Time Shop Floor Oversight
- Perform on-the-floor quality assurance support during manufacturing, cleaning, and environmental monitoring operations.
- Monitor adherence to GMP practices during critical manufacturing steps (e.g., line clearance, material dispensing, equipment setup).
- Witness and verify critical process steps, in-process controls (IPCs), and reconciliations.
2. Line Clearance and Batch Execution Monitoring
- Perform and document line clearances before manufacturing operations.
- Review manufacturing processes in real time for compliance with approved batch records and SOPs.
- Ensure proper material handling, labeling, and segregation during production.
3. Deviations and Issue Escalation
- Identify and report deviations or abnormal events on the shop floor.
- Support or lead immediate impact assessment and documentation of on-the-floor deviations.
- Ensure timely escalation and coordination with QA and production leadership for resolution.
4. Batch Record Review and GMP Documentation
- Review completed batch manufacturing records for accuracy, completeness, and compliance.
- Ensure timely corrections to documentation issues and assist operators in proper GMP documentation practices.
- Verify logbooks, equipment use records, and cleaning records on the shop floor.
5. Support for Interventions and Aseptic Practices (if applicable)
- Observe and assess interventions during aseptic operations for compliance with aseptic technique and contamination control.
- Support environmental monitoring activities, gowning practices, and cleanroom behavior compliance.
6. Participation in Routine Checks and Audits
- Conduct routine walkthroughs and spot checks to assess compliance with housekeeping, gowning, and other GMP standards.
- Participate in internal audits and regulatory inspections as needed, providing on-the-floor knowledge and documentation.
7. Shop Floor Training and Coaching
- Provide on-the-job coaching and GMP guidance to operators and technicians.
- Reinforce good documentation practices (GDP) and quality culture.
8. Support for Investigations and CAPAs
- Provide input into root cause analysis based on first-hand observations.
- Support implementation and follow-up of corrective and preventive actions directly related to shop floor findings.
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