Microbiology Reviewer

JOB DESCRIPTION Job Title QC Microbiology Reviewer Job Location Bangalore About Syngene Syngene 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 Facing regulatory and client audits ensuring audit compliance Microbial Method Validation Method verifications Microbiology analysis Bioburden MLT Test for specified organisms BET analysis Sterility testing and validation Environmental Utility Monitoring data review Microbiology lab maintenance Calibrations Qualifications Review of Microbiology data Media and culture qualifications data review and planning Handling QMS in Microbiology lab Role Accountabilities Responsible for 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 Bioburden and Microbial Limit Test Responsible to perform the Method verification activity for Sterility BET MLT and Bioburden test Responsible for ensuring environmental monitoring of clean rooms in Microbiology laboratory Responsible for review of microbiology documents Responsible for preparation of specifications and STP Responsible for preparation of protocols and reports Audit trail review Preparation and planning of sampling schedule Interaction with clients Ready to work in shifts and supervising the shift analyst activities Well versed with LIMS and electronic documents execution and review 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 only for Leadership Hires 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 Experience Demonstrated Capability 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 It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities