Engineer - Quality Assurance
2 weeks ago
To coordinate for Site Complaints from Factory for "Immediate Correction" at site.
To be a part of CAPA Team to ensure CAPA against each site complaint by helping in Root Cause Analysis.
To centrally coordinate for "Spare Part Activities" from factory.
To develop Indian Versions of Operation & Installation Manuals & Control Manuals for machines / accessories.
To work as a part of dispatch team to conduct pre-dispatch inspections.
To coordinate with respective departments to control the short or false supply to site.Great understanding of QA Processes.
Collaboratively work with team to achieve FTR at each process
Work accordance with planning & do execution, Work on challenges faced during, find our solution for the resolution of challenges.
Expert in handling FAT/ TPI / Customer for FAT.
Analysis of customer complaints & support for the CAPA process.
Work on Continuous improvement process.
Get consultation from Manager for clarification on part discrepancies.
Knowledge about Qualification Documents / Certification / Calibration procedures of parts
Knowledge about pharma machineries & testing procedure.
Knowledge about standard Auditing processes & NDT processes (ISO, ASME etc)
To work as a part of FAT Team for highlighting issues affecting installation at site & getting those corrected from respective depts.
To ensure the Site Installation time is reduced with effective I-FAT.
To review the Validation Documents during I-FAT to ensure Site & Customer Requirements are addressed in the documentation,
To review Mechanical BOM, ensuring all the material required on the site holding installation is added to BOM & being dispatched along with machine.
To implement learning from the site in I-FAT protocols for all machines to ensure maximum possible tests are conducted in factory for Electrical & Mechanical Items.
To develop methodology to minimize or eliminate Software modifications required at site during installation.
To re-structure the packing slip to add Tag No. to the packing slip & streamlining the process of packing slip generation for Electrical & Mechanical Items,
People development
Guide the team for the Self certification, FTR Process, Compliance to customer expectation.
Key Result Areas-
Development of strong relationship with CFT Members to achieve quality at source in each activity.
Ensure compliance with quality standards and procedures.
Identify the opportunities for process improvement to enhance a product quality streamline inspection procedure & optimise the efficiency without compromising safety & compliance to customer expectation
Pharma Machinery experience required
If interested please share profile on manjiri.-
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