Executive- Quality Control (Micro)

Roles and Responsibilities

• Responsible for the work allocation, planning and execution of the Microbiological analysis .
• Responsible for handling routine GLP related activities such as, instrument calibration, Validation and preventive maintenance.
• Responsible for Preparation, review, improvement and revision in SOPs as per procedure and implementation from time to time.
• To arrange training for applicable employee and define time line for newly prepared or revised SOP.
• Responsible to perform Sterility Method validation, Bacterial Endotoxin Test Method validation, Microbial Limit Test Method Validation & Disinfectant validation.
• Responsible for planning and execution of In-process, process validation, Semi finished, hold time study, finished product sample related activities.
• Responsible for procurement and management of material for microbiology department Such as Microbial culture, Microbial culture media, Plates etc.
• To participate in Media fill process simulation activities and perform the observation .
• Responsible for operation & monitoring of all equipment and maintain in compliance state.
• Responsible for review of raw data of Environmental monitoring , water analysis , sterility testing , Bacterial endotoxin test , Media preparation , Microbial Limit test ,Microbial culture , Microbial identification test , GPT and compilation of complete Microbiology document for submission to QA.
• Responsible for preparation, execution and review of qualification and validation protocols and reports.
• Responsible for analysis of sample and review of raw data for equipment, validation, Process validation, Hold time Study, Media fill, cleaning validation and Miscellaneous validation activity as per requirement.
• Responsible for execution and review of computerized system documents with respect to computer system validation.
• Responsible for coordination to quality assurance and Production department for sampling and analysis planning and management .
• Responsible to review annual GxP / Technical training planner as per requirement and its plan of execution.
• Responsible for initiating and participating in Quality Management System such as Change Control, Incident, Investigations, CAPA and non-conformance.

Desired Candidate Profile

Candidate Should be from Pharma background

Prefer who can work in a shift and is willing to work at location Pithampur , Near Indore (M.P)

Email Id : [email protected]