Job
Description
Job Responsibilities: Preparation and review of SOP, Validation procedures, General testing procedures, Protocols, Summary reports, Trends, Investigation reports, Risk assessments, Rationale, Quality policies, Audit responses, Justification notes, CAPAs and related documentation. To ensure availability and implementation of approved specifications, sampling instruments and test methods Check and review analysis of packing material, raw material, in process and finished goods Preparation of raw data sheets for raw material, packing material, in process and finished goods Preparation, execution and review of validation protocols and equipment qualification protocols. Verification and approval of laboratory analytical reports of MLT, Water, Environmental Monitoring, Bioburden of In-process Materials, Bioburden analysis as per current specification and SOPs. Review and Monitoring of all types of routine non routine activities like calibration, validation, Media Preparation, Culture handling, water analysis etc. Review of daily documents like usage log books of instruments, temperature differential pressure humidity records, cleaning records, sampling records, RDS, COA and various assigned registers entry To carry out analysis of In-process, raw material, packing material and finished goods and Preservative efficacy test micro biologically. To ensure the compliance of laboratory system, GLP and cGMP To ensure Environmental Conditions Pharmaceutical Water qualities are maintained in respectively by preparing and reviewing the Trends of Environment Monitoring Water Risk assessments and Rationale for MLT, Water, BCC and Environment Monitoring. Sampling microbial analysis of raw water, portable water, purified water as and when required Sampling frequency reducing and Structural problem solving. Co-ordinate within and other departments as and when required Work distribution and allocation amongst subordinates as per the requirements Pedigree: B.Sc/ M.Sc (Microbiology) with relevant 8-12 years of experience
