Execution of Media, Buffer, Washing, and Sterilization & Inoculation preparation activities
Assist in review of Records, SOP, logbooks, and monitoring charts for completion and ensure accuracy of all documents as per GMP guidelines.
Train and ensure technical staff comply to GMP, HSE, and SOP requirements.
Participate in daily meetings and report findings to management.
Participate in deviation investigations and root cause analysis.
Coordinate with units within department (MWS, Upstream and Downstream)
Provide training to personnel.
Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.
Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to (MWS, Upstream and Downstream processes).
Preparation of media, buffer, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, warehouse
Perform activities and documentation involved in MBWS and Upstream including, in buffer preparation, washing and sterilizing, inoculation preparation, infectivity testing, and material handling.
Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
Provide guidance to technical staff on problem solving and trouble shooting.
Ensure area is inspection ready. Knowledgeable to guide inspectors.
Material handling, movement an organization and storage. Reorder parts as per guidance from TGL's.
Administration of data for drug substance operations and preparation of trending reports for analysis
Document and review production and monitoring activities for drug substance manufacturing
Complete SAP transactions in a timely, accurate manner.
Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).
Ensure all data is completed timely and accurately in LIMS, Master, Change Request Forms, PCS and EM svstem.
Health, Safety and Environment and maintenance of GMP environment
Participate in keeping the production area and office areas in a tidy, GMP manner, following 5S guideline or equivalent and supply materials as required
Disinfect area as required in SOP.
Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
Use proper PPE when performing tasks.
Follow HSE SOP's, identify and minimize risks, promote safety culture.
Ensure chemicals are stored as per HSE requirement and has MSDS available.
Process improvement, development, and preparation of trending reports for SPC analysis
Assist implementation of facility, equipment, and process improvement projects
Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process
Modification of SOPs and BPR's for new processes in accordance with change control policies
Perform activities involved in IQ, OQ, and PQ for new equipment
Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates
Collaborate with other departments for root cause analysis and assist with implementation of corrective actions
Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position
