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Executive QMS

0.00 to 3.00 Years   Bangalore, Chennai, Hyderabad, Kolkata   29 Dec, 2021
Syngene International Limited
Job LocationBangalore, Chennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Designation: ExecutiveJob Location: Bangalore, Biocon ParkDepartment: Quality Assurance -BiologicsAbout 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.

  • Prepare, review and approve risk assessments pertaining to facility, process, product and safety.
  • Log, review and maintain the QMS elements such as Change controls, Deviations, customer complaints and CAPA.
  • Conduct investigation on the deviations and manufacturing investigations of OOS.
  • Represent QMS function in the PRMs/Client telecons for a nominated project.
  • Training of self and other employees on the GDPs, GMPs and QMS.
  • Compile QMS data for the monthly meetings, Quality Review meetings and Quality Huddle.
  • Initiate continuous improvements on the QMS and any Quality process within Biologics QA.
Key Responsibilities:
  • Responsible for Quality Assurance activities pertaining to Biologics manufacturing unit (In-process QA activities of Biologics Manufacturing Plants).
Educational Qualification:
  • Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering/Microbiology
Technical/functional Skills:
  • Knowledge on Biologics Manufacturing and testing compliance requirements.
  • Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
  • Clean room knowledge
Experience:
  • 0-3 years of experience in Biopharma manufacturing/testing/compliance/Quality Assurance.
Behavioral Skills:
  • Aggressive but assertive on task completion.
  • High influencing skills to complete the task at hand.
  • Ability to provide solutions for complex problems.
  • Eye for detail.
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 :
colorequal employment opportunitycustomer complaintsriskconsumer goodsquality assurancelegislative relationsanimal healthreligionscienceqmscontinuous improvement facilitationadditiontesting

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