Walk In For QC ( Microbiology)

Role & responsibilities

• Environment monitoring of QC and production area.
• To prepare Trends of Environment monitoring and water testing.
• Sterility Test, sterility test observation and sterility test method validation.
• Establishing procedures for Microbiological testing, Documents review.
• Preparation of all microbiology documentation, training and effectiveness of documents.
• Microbial testing of Water, Bioburden, Raw material, Bulk samples its release & documentation.
• Maintaining Good Laboratory Practices throughout the Quality Control laboratory and good documentation practices
• Checking of daily release sterility test tubes & documentation.
• Bacterial Endotoxin Testing, method validation & its review.
• Participation in Investigation of Event, Change control, OOS etc.
• Media Praparation, Stock and consumption records with traceability.
• Microbiological validations to be performed.
• Responsible for product quality, sampling, inspection & testing
• Viable and Non-viable particle count monitoring in production & Quality Control area.
• Avoid spillage of chemicals and media during material handling & dispensing.
• To ensure control and segregation of generated waste material and maintain record for the same.
• Act as the pollution Prevention, Accident Prevention, Waste minimization and Energy team wherever applicable.
• To implement, follow & documentation of Objectives, Target and Management Program.
• Reporting immediately on non-conformance, incident and documenting the same.
• To understand and follow environmental Occupational Health and Safety, Energy and quality policy.
• Understand, Train, Implement and follow the OCP for preventing, reducing or eliminating the significant aspects, Energy loss and risks in respective area.
• Follow all the Safety & Environment, energy rules as per legal register and systems and procedures as per EOHSMS such as work permits, OCP, work instructions etc.
• To communicate Environmental and Safety, Energy objectives / targets to all.
• To initiate corrective and preventive action in Environmental and safety incident, Energy loss.
• Chemical management, maintain updated MSDS of all chemicals.
• To ensure compliance of legal & other requirements in quality assurance area.
• Resposible for training co-ordinator for departmental trainings.
• Report Adverse Drug Reactions (ADRs) and Complaints about Fresenius Kabi PU Pune's products from domestic and export markets to the respective market units immediately after receipt, but latest within 1 business day.

Preferred candidate profile

M.Sc Microbiology