Asst. Manager Microbiology

JOB DESCRIPTION

Job Title: Microbiologist

Job Location: Syngene Unit 3 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:

• Responsible for sterility testing using isolator and 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

Role Accountabilities

Sterility testing by using Isolator.

Having knowledge of QMS and LIMS.

Qualification and validation.

Routine Microbiological activity and laboratory support.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience

06-10 Years

Skills and Capabilities

Good knowledge on Microbiology skills and techniques.

Sterility testing.

QMS knowledge.

Work as a team and have collaborative mindset.

Good communication skills.

Education

M.Sc in Microbiology or Biotechnology

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.