Lead - Tech support (LIMS/ELN-Microbiology)

Job Title: Lead - Tech support (LIMS/ELN-QCM)

Job Location: Bangalore

About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned


• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards


• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.


• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.


• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self


• Compliance to Syngene s quality standards at all times


• Hold self and their teams accountable for the achievement of safety goals


• Govern and Review safety metrics from time to time

Core Purpose of the Role :

• Static data creator/ reviewer for LIMS


• Validation of LIMS and ELN sheet


• Thorough knowledge on LIMS development, validation and GMP modules


• Knowledge on guidelines requirement for microbial analysis


• Ensure Microbial Method Validation, Method verifications


• Planning Microbiology analysis (Bioburden, MLT, Test for specified organisms, BET analysis)


• Sterility testing and validation


• Calibrations, Qualifications in Microbiology lab


• Handling QMS in Microbiology lab

Role Accountabilities

• Documents preparation/review/validation for LIMS and ELN for microbiology


• Facing regulatory and client audits, ensuring audit compliance


• Leading team for Microbial analysis section


• Ensuring Microbiology lab maintenance


• Media and culture qualifications data review and planning


• Responsible for Ensuring Microbiological analysis, Sterility testing, Bacterial Endotoxin Test and analysis of different grades of water (PW/WFI/POW) as per the respective specification.


• Responsible for risk assessment documents preparations, Protocol and reports preparation


• Responsible for QMS related to microbiology - change controls, CAPA, deviations, incidents, OOS/OOT investigations


• Responsible for Area qualification, calibrations, equipment qualifications and requalification


• Responsible for sample management and coordination with team for smooth operation of samples release activity.


• Responsible to perform the Method verification activity for Sterility, BET, MLT and Bioburden test.


• Responsible for review of microbiology documents


• Responsible for review of specifications and STP.


• Responsible for review of protocols and reports


• Preparation and planning of sampling schedule


• Interaction with clients


• Ready to work in shifts and supervising the shift analyst activities


• Follow the required EHSS policies and Good hygiene practice.


• Undertake other responsibilities related to Microbiology as per requirement.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence


• Integrity


• Professionalism

Accountabilities as a Syngene Leader

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.


• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

1. Experience :

1. Demonstrated Capability :

1. Education :

Experience : 9-10 yrs YEARS

Skills and Capabilities

• Microbial analysis of water, OSD products, Injectable products, Environmental monitoring


• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team


• Good speaking-listening-writing skills, attention to details, proactive self-starter


• Ability to work successfully in a dynamic, ambiguous environment


• Ability to meet tight deadlines and prioritize workloads


• Ability to develop new ideas and creative solutions


• Should be able to work in team and flexible for working in shifts


• Should be a focused employee


• Good documentation capability

Education : M. Sc. Microbiology

Equal Opportunity Employer

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