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Documentation o Assist to Preparation of all SOPs, Logbook, Calibration Record, Temperature Records, and Formats as per regulatory requirements.. o Preparation, Issuance & control of Label for finished Product. o Assist to Handling of CAPA, Deviation and Change Control. o Co-Ordination with Production for all Validation Activities. o Preparation of Process validation report o Analysis – trend analysis of various parameters QA activity: Distribution / Issuance of BMR’s, SOP and Formats to the respective department o Prepare specification as per pharmacopoeia, in house test and as per customer requirement. o responsible and has authority to complying all production, despatch and packing process as per define quality standards and assuring all process as per plan and specification o Support and guide to other department for GMP and FSMS activity as per guideline. o Collection of control samples, semi-Finished Sample and Stability sample. o Assist to Handling of CAPA, Deviation and Change Control o Audit / Visit: Dispatch activity: Prepare labels as per customer requirement and issue to packing department. Cross check packing activities like, bag filling, stitching, pallet preparation and loading. Container observation – i. Check empty container and send final report within 30 Minutes after security information. ii. Check proper stacking of loading material