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.
