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Senior Executive- Stability Operations

3.00 to 6.00 Years   Chennai   17 Aug, 2021
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Designation: Senior ExecutiveJob Location: Bangalore.Department: Quality Control Common: Late phase StabilityAbout 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.

  • Maintenance and Monitoring of Stability Chambers. Dat
  • Initiation of Stability study and sample pull outs.
  • Preparation of Stability Protocols, Stability monthly schedule and Alarm Trending for Stability Chambers.
  • Preparation and review of SOP s and IOP s.
  • Responsible for Initiation and Closure of Change controls, Deviations and CAPA s
  • Responsible for Stability chamber qualification/Requalification as applicable.
  • Responsible for updation of Labware LIMS flow and performing qualification as per requirement.
  • Responsible for audit readiness.
  • Ensure and comply with EHSS and safety policies laid down by the organization.
Key Responsibilities:
  • Stability study management.
  • Stability chamber Management
  • Initiation of QMS records on time.
  • Provide support to End user for Labware LIMS
Educational Qualification:
  • M.Sc. (Analytical Chemistry/Organic Chemistry)
Technical/functional Skills:
  • 3 to 6 years of working experience in Stability or Quality control.
  • Candidate should have knowledge of Stability sample management.
  • Experience in preparation of SOP s/IOP s.
  • Candidate should be aware on management of QMS documents
  • Experience in Labware LIMS, Trackwise will be added advantage.
  • Good understanding of GMP, GDP and data integrity principles.
  • Quick learner and early change adaptor.
  • Experience in regulatory audits is must.
Experience:
  • 3-6 years of working experience in Stability and Quality control. (Drug substances and drug products)
Behavioral Skills:
  • Effective time Management.
  • Reading Comprehension
  • Communicating effectively: verbally and writing
  • Team player.
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 :
miscustomer relationsregulatory auditsconsumer goodsanimal healthcustomer servicedata integritylegislative relationssalesworking experiencequality control

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