About this role
Documentation
- To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice.
- Ensure that all documents / records required for Regulatory Compliance are maintained properly.
- Ensure old records are archived properly and are retrievable.
- To check online filling of document & online submission to QA department.
- Raise change control/ Deviation/ CAPA in OASIS LIMS.
- To support SAP transaction in production module as & when required.
- Raise indents for Consumables, parts, Stationary and Spares required for the plant.
- To ensure for high standards of housekeeping in plants.
- To maintain all records and documents as per GDP/SOPs.
- To take lead in audit preparedness and report to factory manager in case of any deviation.
- To maintain training records of employees in respect of training SOP.
Production
- To perform the role of production officer/executive as and when required.
Cross Functional Department
- To coordinate with QA, department for compliance.
- To coordinate with QC, PD Lab, Engineering and HR etc. for GMP Compliance.
- To coordinate with EHS for safety and environment related audits.
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