Senior Officer
Job Description
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.