Full Name (Block letters/ Capital)

Gender

Current City

State

DEEEKSHA DUBEY

Female

AGRA

UTTAR PRADESH

PATEL JYOTI RAMESHBHAI

Female

Surat

Gujarat

SNEHA SAHA

Female

Kolkata

West Bengal

ANUSREE DAMODARAN

Female

Lucknow

Uttar Pradesh

Himanshu Sisodia

Male

Jaipur

RAJASTHAN

Neha Sharma

Female

Jaipur

Rajasthan

ADITI SAINI

Female

MEERUT

UTTAR PRADESH

CHAUDHARI CHANDA SHANKAR

Female

Surat

Gujarat

SHYAM SUNDAR TIWARI

Male

Kolkata

West Bengal

SANGITA PAUL

Female

Burdwan

West Bengal

POONAM BAGHEL

Female

BHOPAL

MADHYA PRADESH

ANUSHKA SAMEER KUDALE

Female

Pune

Maharashtra

CHAUHAN CHARMI JITENDRABHAI

Female

AHEMEDABAD

GUJARAT

PRABHAT PANDEY

Male

Gopalganj

Bihar

KRUPALBEN VIJAYKUMAR RANA

Female

VADNAGAR , MEHSANA

GUJARAT

MONISHA VERMA

Female

Lucknow

UTTAR PRADESH

• Life Sciences industry in Indian and global context

• regulatory authorities, regulations, legislation, and good practices relevant to the quality assurance in a life sciences manufacturing facility

• basic skills required to perform the job of Microbiologist-Quality Control.

• impact of non-compliance on the quality of the product and the environment

• quality principles and concepts applied in the life sciences sector.

• basic concept of Quality by Design (QbD) and its application in quality control, quality risk management.

• fundamental concepts of Microbiology

• principle of biochemical characterization of microbes by Gram stain and biochemical cards and their standard detection limits.

• the units of measurements of microbial growth.

• sampling plans for microbiological sampling

• Personal Protective Equipment (PPE) used in the microbiology lab.

• different quality management systems, quality specifications and policy of the company.

• properties and storage conditions of different chemicals and reagents used in a microbiology lab

• principle of calibration and validation of equipment/glassware used in the lab

• strategies to minimize the risks of cross-contamination, false-positive and false negative results

• different strategies used for decontamination in a microbiology laboratory

• different sterilization processes used in a microbiology laboratory.

• concept and importance of energy conservation.

• possible actions to optimize energy consumption and minimize energy wastage.

• concept of environmental pollution and its impact on the health of self, community, and planet.

• possible actions to be taken to minimize environmental pollution at work.

• various guidelines to be followed for hazardous waste management and disposal of waste

• properties of different microbial culture.

• basic techniques used for microbiological analysis.

• working principle and application of equipment used in a microbiology lab.

• optimum growth conditions for different microorganisms.

• method and importance of containment of microorganisms within the laboratory facility.

• Out of Trend (OOT) and Out of Specification (OOS) samples.

• different scientific literature search tools.

• how to develop new testing protocols for microbiological analysis.

• procedure to grow different strains of bacteria in various conditions for their molecular and cellular characterization.

• relevant legislative requirements and company’s procedures for the environment and health.

• workplace hazards and their reporting in a manufacturing facility in the life sciences sector.

• the guidelines and procedures for hazards, accidents, safety signs and signals, and Heinrich pyramid used in a manufacturing plant.

• Health, safety, and accident reporting procedures.

• importance of the gowning, medical assistance and emergency services.

• procedures for evacuation for employees, contract staff, and visitors in controlled areas.

• types of safety gears and procedure to use them.

• WHO guidelines for personal hygiene, handling, and storage of hazardous material.

• importance of material segregation and 5S system.

• types of documentation in an organization and the importance of maintaining the same.

• method of reporting and documentation as per Good Documentation Practices (GDP) and other regulatory guidelines.

• Attributable, Legible, Contemporaneous, Original, and Accurate Plus (ALCOA +) principle and its importance.

• how to use lab information management system.

• statistical concepts and application of statistical tools.

• guidelines for Electronic Records & Electronic Signatures, Audit Trails, Date and Time Stamps, Data Integrity in the life sciences sector

• the reporting structure of the organization.

• List the functional and cross-functional stakeholders for Microbiologist-Quality Control .

• efficient and clear communication methods for reporting incidents/ deviations.

• techniques for gaining emotional stability.

• various ways for conflict resolution.

• best strategies of collaborating with others.

• the problem-solving techniques for routine work-related issues.

• type of audits in the life sciences sector for the quality operations.

• rules laid by the Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressal) Act and the provided penalties for violation.

• importance of gender sensitive behavior.

• Explain the procedure to report inappropriate behavior e.g. sexual harassment.

• Describe the importance of an equal opportunity work culture.

• Discuss the importance of respecting other’s cultures, religion, and caste.

• the need for sensitivity towards people with disabilities.

• the correct ways of communication and collaboration with people with disabilities in compliance with the legal framework.

• Identify stereotypes and prejudices associated with people with disabilities and the negative consequences of prejudice and stereotypes.

• Introduction to Employability Skills Duration:

• Demonstrate sampling methods for conducting microbial test according to SOP.

• Demonstrate sample handling and preparation of microbial samples

• Demonstrate the use of Good Storage Practices (GSP) guidelines for storage of samples.

• Identify microbes using phenotypic and genotypic methods.

• Demonstrate the use of PPE in a Microbiology lab.

• Conduct regular checks for lab equipment and instrument for their calibration and validation state.

• Identify out of order/ non-calibrated/ non validated equipment.

• Demonstrate how to apply the decontamination strategies for contamination control in a microbiology laboratory.

• Demonstrate the steps of sterility testing.

• Demonstrate how to maintain positive and negative controls during testing.

• Demonstrate how to perform laboratory specific checks as per Standard Operating Procedures (SOP).

• Create a checklist of energy conservation practices during and post-work.

• Segregate waste into recyclable, non recyclable, and hazardous.

• Demonstrate the sustainable waste disposal- process.

• Demonstrate how to prepare media to conduct quality analysis on the samples.

• Demonstrate how to prepare and maintain standard cultures.

• Perform microbial isolation, plate pouring, serial dilutions and screening of microbes.

• Demonstrate how to operate equipment in a microbiology lab.

• Demonstrate how to perform sample specific microbial tests for detection of different microorganisms in samples.

• Demonstrate the how to identify the reason for unwanted growth of microorganisms.

• Demonstrate how to record and report the observations of the microbial test performed.

• Demonstrate how to perform the literature search for culture/media development for different microbial strains.

• Demonstrate how to grow different microbial strains in various conditions to understand their reactions.

• Demonstrate how to ascertain the breach of EHS protocols in a given situation.

• Demonstrate how to communicate hazards, safety instructions and accidents to teammates and cross-functional teams.

• Demonstrate how and when to follow instructions, guidelines, procedures, rules, signage, codes for different situations and processes.

• Demonstrate how to perform reporting and documentation as per GDP and other regulatory guidelines.

• Prepare inspection reports as per inspection activity performed.

• Demonstrate the use of computer/ and software like MS Office, or its alternative for reporting

• Demonstrate how to effectively communicate and collaborate with various stakeholders (e.g. manager, groups etc.) in a simulated environment for multiple scenarios.

• Demonstrate how to resolve conflict in multiple scenarios.

• Demonstrate how to communicate with auditors and regulatory inspectors during inspections/audits.

• Demonstrate the training procedures to train lab assistants and trainees.

• Demonstrate appropriate verbal and nonverbal communication that is respectful of gender, religion, disability, etc.

• Prepare a list of gender-neutral communication terms.

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Aditi saini- M.Sc. Microbiology