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Associate Scientist

2.00 to 4.00 Years   Bangalore   31 May, 2021
Syngene International Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Designation: 9-II/8-IJob Location: BangaloreDepartment: BBRC PD ARDAbout SyngeneIncorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Job Purpose (1-2 Lines): To have a person responsible for the below mentioned key activities in PD ARD GMP labsKey Responsibilities: (Maximum 5-8 Points) -

  1. Analysis of API clinical manufacturing campaign samples manufactured in Syngene facilities.
  2. Execution of UPLC, HPLC and GC analytical method validation/qualification for drug product and API.
  3. Qualification of API reference standards.
  4. Preparation and review of analytical method report/validation summary.
  5. Analysis of specification set batches.
  6. Release testing for Drug product, APIs and intermediates for clinical use.
  7. Execution of analytical method qualification/validation.
  8. Preparation and review of analytical method validation/qualification protocol.
  9. Ensure the proper functioning of instruments in the laboratory. Co-ordinate with the preventive maintenance team to ensure preventive maintenance is carried on time.
  10. Calibration of instruments as per schedule on need basis.
  11. Maintenance of equipment usage logs.
  12. To raise OOS/deviation, wherever applicable.
  13. Review of laboratory notebooks and calibration records of all Laboratory equipment/instruments.
  14. Preparation/Review of Product specifications and Analytical results for clinical campaign materials.
  15. Experience in handling electronic systems like eln, EDMS and EQMS etc.
  16. Experience in GMP Analytical lab to execute above mentioned activities.
Educational Qualification: MSc /M.PharmTechnical/functional Skills: (Maximum 4-6 Points):1. Knowledge on Analytical instrument like Dissolution, UPLC, HPLC, GC, etc2. Knowledge on Computer system validation (CSV), Compliance and Quality management system (QMS).Experience: 2 to 4 Years Behavioral Skills: Adaptability/Flexibility, Problem Solving/Analysis, Integrity/EthicsEqual 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 :
documentationcomputer system validationsetprotocolsgmpsopcontinuous improvement facilitationquality management systemapimanagement systemhplcconsumer goodsquality managementlegislative relations

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