LIMS/ELN and Digitalization Specialist

JOB DESCRIPTION

Job Title: Junior Manager (Digitalization efforts) - Quality Control

Job Location: Bangalore, Biocon Park

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

Core Purpose of the Role:

• To handle LIMS operations in Quality control
• Creation and validation of ELN (Electronic Lab Note) Template
• Creation of static data in LIMS
• Digitalization and associated validation in QC
• Computer system validation

Role Accountabilities:

• To implement digitalization efforts in QC
• Ensure LIMS implementation and operations
• To develop ELN, validate and implement
• Creation of Static data in LIMS
• To digitalize the lab and perform associated validation and CSV efforts
• To perform computerized system validations for lab applications
• Custom filed implementation in Empower
• Any associated digitalization efforts in QC

Leadership Capabilities

- Decision making

- Guidance to team

-Adherence to timelines

-Compliance

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role:

• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Ability to provide solutions for complex problems.

Demonstrated Capability-

1. Knowledge on digitalization efforts in QC
2. Exposure to Labware LIMS, ELN implementation and validation
3. Subject Matter expert on the Guidelines/regulations pertaining to digitalization and CSV
4. Tactful communication

Education

M. Sc. (Biochemistry/Chemistry)

Experience

09-12 years

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.