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LIMS Supervisor

9.00 to 14.00 Years   Bangalore, Chennai, Lucknow, Hyderabad   21 Jan, 2022
Sygene
Job LocationBangalore, Chennai, Lucknow, Hyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Designation: Assistant Manager Job Location: BangaloreDepartment: Clinical Development - Laboratory ServicesAbout SyngeneSyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.Key Responsibilities:

  • Read, understand and comply with the relevant procedures and processes described as per the quality management system
  • Read, understand and comply with protocol and project management plan requirements for all activities performed
  • Responsible for Central Laboratory Data management.
  • Supervisor for Laboratory Information Management Systems (LIMS).
  • Interact with IT (systems) department to manage LIMS and maintain business logic.
  • Analysis, performance monitoring and maintenance of the Laboratory Information Management System
  • Handling project related data.
  • Ensure LIMS performance meets the laboratory day to day requirement.
  • Ensure safe archival and back up of data generated on the LIMS.
  • Maintain data quality as per applicable standards.
  • Project access management on LIMS.
  • Setup and execution of projects as per the sponsor protocol and PMP/PSW on LIMS.
  • Notify the laboratory director of all issues or problems impacting the performance of the laboratory information management system.
  • To identify and resolve problems on LIMS that may adversely affect analysis of samples, management of projects and/or reporting of test results.
  • Represent the laboratory in the domain of data management at audits (Sponsor/Regulatory/Accreditation Bodies).
  • To ensure data integrity that meets compliance requirements.
  • Other responsibilities and duties which may be designated from time to time.
  • Lab data transfer to the clients as per the Lab data transfer specification plan.
  • Prepare and/or review standard operating procedure
  • Monthly data extraction for TAT.
  • Sample testing data compilation for monthly billing.
  • Complete management of Annual health check-up (AHC) procedure with respect to IT and Central laboratory from the Samples registration till the report distribution.
  • Preparation of User requirement specifications with respect to IT related applications of Central lab.
  • Performing testing of IT related central lab applications as and when required.
  • Supervisor for Power LINK interface application.
Educational Qualification: BCATechnical/functional Skills:
  • English language proficiency is required (oral and written)
  • Should have good interpersonal skills
  • Large degree of flexibility and ability to work under strong time pressure
Behavioral Skills:
  • Should be independent.
  • Good communication.
  • Able to balance work and life
  • Should have time management
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.,

Keyskills :
continuous improvement facilitationconsumer goodsequal employment opportunitydata extractionanimal healthdata managementproject management plandata qualitydata integrity

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