QC - Microbiology

Position Title: QC - Microbiology

Job Level: Experienced

Location: Bengaluru, India

About Syngene: Syngene is seeking a seasoned professional to lead its Technical Training function, responsible for building and scaling learning programs that strengthen the scientific and technical capabilities of our workforce. This leadership role is pivotal in ensuring our teams across R&D, manufacturing, and analytical services are equipped with the latest skills and knowledge to meet evolving client expectations and regulatory standards.

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

Role Accountabilities:

• Responsible for BET analysis using KTA/PTS.
• Track and complete the qualification and requalification of equipment/instruments of Microbiology laboratory.
• Responsible for initiation of OOS, Deviation, Change control and CAPA.
• Investigations and timely closure of OOS, Deviations and microbial data excursions, CAPA’s and change controls.
• Involve in preparation of SOP/SOP-E/GP/Specifications and relevant Annexure.
• Involve in Analysis of RM, FP, Stability samples as per respective specification for the applicable tests such as Microbial Enumeration Test, Test for Specified Microorganisms, Qualification/ Verification activity.
• Involve in QCM related activities such as Sterilization, Media Preparation, Growth Promotion for media, Culture maintenance, Media Disposal, Equipment Calibration and Validation, Qualification /Verification activity, Cleaning and fumigation of microbiological laboratory, Identification of water and environment isolates, Reviewal of Temperature monitoring record of equipment and clean room.  Clean room pressure differential, Media fill validation etc. in QCM Laboratory
• Preparation of microbiological trend data for the facility in a suitable format. Maintains track for material requirement and requests the same as per the requirement.
• Plans and schedules analytical activities in the department and ensure compliance with SQDECC parameters.
• Undertakes any other task allocated by HOD or team leader as required

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Education: M.Sc. in Microbiology.

Skills and Capabilities:

• 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

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.