Documentation Officer/Executive - QA

To review and implement Quality Managements System for cGMP compliance at site. To review of production and quality control documentation for compliance with GMP and GLP requirements. To handle/support QMS events (Deviation, Change control, CAPA, incidence etc.) To handle/support Quality Risk Assessment and management activities. To review SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. To handle/support customer query compliance. To handle Nichelon software, Dynamic software, E-logbook, E-complaint, Mint DC software. Line clearance, in process and sampling of various stages of RM/PM, Production and Packing area. Process validation and Cleaning validation process. To review Batch production records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. To monitor qualification, validation and requalification activity at site. To review ongoing process verification. To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit. To inform Management on quality issue (if any). Interested candidates can share resume on dipika.parmar@milanlabs.com