Executive- Quality Control (Micro)

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 400,000 - 640,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a Pharma-qualified professional for a Microbiology QA role in Indore. You will lead microbiological analyses, ensure GLP compliance, and manage SOPs and validations.

The role requires coordination of training, material management, and participation in quality systems and CAPA processes to ensure data integrity.

Qualifications

• Candidate should be from pharma background.
• Willing to work in shifts at Pithampur near Indore (M.P.).
• Experience with GLP, SOP preparation and validation preferred.

Responsibilities

• Work allocation, planning and execution of microbiological analysis.
• Handle routine GLP activities including instrument calibration, validation and preventive maintenance.
• Prepare, review, and revise SOPs and implement updates.
• Arrange training for applicable employees and define timelines for revised SOPs.
• Perform sterility, bacterial endotoxin, microbial limit, and disinfectant validations.
• Plan and execute in-process, process validation, hold time studies, and related sampling.
• Procure and manage microbiology materials such as media, plates, and cultures.
• Participate in media fill process simulations and observe outcomes.
• Operate and monitor all equipment, ensuring compliant state.
• Review raw data from environmental monitoring, water analysis, sterility tests, etc., and compile microbiology documents for QA.
• Prepare, execute and review qualification and validation protocols and reports.
• Analyze samples and review data for equipment, validation, process validation, hold time, media fill and cleaning validation.
• Coordinate computerized system documents for computer system validation; liaise with QA and Production for sampling and planning.
• Review annual GxP/Technical training plan and execute as required.
• Initiate and participate in Quality Management System activities (Change Control, CAPA, investigations, non-conformance).

Skills

GLP knowledge

Microbiology

SOPs

Quality Assurance

Education

Pharma background

Job description

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)