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Lims/Eln And Digitalization Specialist

9-12 years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Junior Manager (Digitalization Efforts) - Quality Control
Date: 21 Jan 2025
Job Location: Bangalore, Biocon Park


About Syngene

Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization offering integrated scientific services across the product lifecycle—from early discovery through commercial supply. Syngene places a strong emphasis on safety, aligning it with business performance. All employees are expected to follow safety guidelines, procedures, and SOPs with shared responsibility for a safe working environment.


Core Purpose of the Role

The Junior Manager (Digitalization Efforts) in the Quality Control (QC) department is responsible for handling LIMS (Laboratory Information Management System) operations, creating and validating ELN (Electronic Lab Notes) templates, and implementing digitalization efforts within the lab. The role also includes overseeing computerized system validations (CSV) and data creation in LIMS.


Key Responsibilities

Digitalization in Quality Control:

  • Oversee the implementation of LIMS within QC operations.
  • Lead the creation, validation, and implementation of ELN templates.
  • Develop and manage static data in LIMS.
  • Digitalize laboratory processes and ensure appropriate validation efforts are completed.
  • Perform Computerized System Validation (CSV) for lab applications and systems.
  • Implement custom fields in Empower for lab data management.
  • Manage and oversee digitalization-related activities in QC to enhance laboratory efficiency.

Compliance & Safety:

  • Ensure adherence to Syngene’s quality standards and regulatory requirements for digitalization and lab applications.
  • Maintain strict compliance with all internal and external guidelines related to data integrity, CSV, and digitalization.
  • Lead by example in promoting a safety-first culture in the QC department, ensuring that safety protocols are followed at all times.

Leadership Capabilities

  • Decision Making: Able to make informed decisions that ensure successful completion of tasks and projects.
  • Team Guidance: Provide clear leadership and direction to the team, ensuring all efforts align with organizational goals.
  • Adherence to Timelines: Ensure tasks are completed on schedule and within project timelines.
  • Compliance: Maintain and enforce compliance with industry standards and regulations in all digitalization efforts.

Specific Role Requirements

  • Task Completion: Aggressively pursue task completion while maintaining high standards of quality and accuracy.
  • Problem-Solving: Ability to address complex challenges and provide innovative solutions.
  • Influencing Skills: Use effective influencing techniques to achieve project goals and encourage collaboration.

Qualifications

Education:

  • M.Sc. in Biochemistry, Chemistry, or a related field.

Experience:

  • 9-12 years of experience in quality control, digitalization, and LIMS/ELN operations.
  • Expertise in Labware LIMS, ELN implementation, and validation.
  • Experience with Computerized System Validation (CSV) and regulatory guidelines related to digitalization in the QC environment.

Skills:

  • Strong communication and influencing skills.
  • Subject matter expertise in digitalization efforts and regulatory compliance for lab applications.
  • Ability to manage complex tasks and provide clear solutions.

Syngene Values

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunities to all individuals, regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. Reasonable accommodations will be provided for qualified individuals with disabilities.

For more details, visit www.syngeneintl.com.