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Manager - Informatics

9.00 to 12.00 Years   Kolkata   09 Feb, 2023
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

    Roles and Responsibilities:
    1. Responsible for leading informatics operation and support for informatics applications of Syngene
    2. Understand the critical business process needs in various departments/operations of the organization and suggest solutions / ensure development and implementation.
    3. Implement new projects/solutions as per business needs. Coordinates between scientists and vendors for any solution development/implementation
    4. Coordinate with Syngene clients to roll out scientific applications at Syngene
    5. Facilitates computer system validation and ensures that scientific applications running in the GxP area are always in a validated state.
    6. Responsible for ensuring 21 CFR Part 11 compliance for enterprise & standalone applications
    7. Focus on near-zero downtime for enterprise applications for planned and unplanned downtime
    Qualification Postgraduate in Science/MCA with a minimum of 9 - 12 years of IT experience in the Pharmaceutical / Life science domainTechnical Skills
    1. Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry.
    2. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications.
    3. Familiarity with basic scientific concepts (calibration, basic statistics, etc.) desired
    4. Experience with Software development life cycle (SDLC) and Computer System Validation (CSV). Should have experience in running projects with CSV life cycle.
    5. Candidate should have knowledge of current regulatory & Guidelines (GAMP5) for CSV, i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems w.r.t. data security, traceability and integrity.
    6. Must have excellent command over industry business processes across business functions and experience working in the Indian CRO/Pharmaceutical market.
    7. Candidate should be familiar with GCP, GLP and GMP guidelines/SOPs.
    8. The candidate should have skills to manage Regulatory & Client Audits (experience in supporting internal and external audits).
    Other Skills:
    1. Strong leadership, communication, consulting and influencing skills.
    2. Must have experience in resource management - channelizing resources to track current and future program resource assignments.
    3. Must have excellent team collaboration skills and the ability to lead and motivate cross-functional teams.
    4. Strong analytical and communication skills are required.
    Behavioral Skills:
    • Strong commitment to exceptional customer experience, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
    • Excellent 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.
    ,

Keyskills :
laboratory information management systemcomputer system validation

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