1. Performs laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy / regulation to generate reliable and timely results, to comply with releases due date, reducing cycle time, and providing internal / external customer satisfaction.
- The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured.
- In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.),
- The tasks are: preparation and sterilization of materials needed for the analysis such as culture media and the depyrogenation / sterilization of glassware.
- Environmental surveillance of aseptic and oral dosage form manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring.
- Generates environmental trends and graphs of the controlled environments, post then in the manufacturing areas and discuss them with manufacturing personnel.
- Audit of aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required.
- Audit the controlled areas and utilities physical conditions (house-keeping) and generates audit corrective actions if required.