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Senior executive- QA GLP

0.00 to 3.00 Years   Chennai   28 Jun, 2021
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Designation: Senior ExecutiveJob Location: BangaloreDepartment: Quality Assurance - GLPAbout Syngene Incorporated 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 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.

  • Ensure compliance to the OECD principles of GLP.
  • Receipt and dispatch of documents/SOPs, Study Plans and Study Reports.
  • Preparation and /or review of SOPs and other documents related to QAU.
  • Perform review of documents and conduct study based and process based audit/inspections in Bioanalytical, Physical-chemical testing.
  • Review of Study Plans, Study Plan Amendments, Study Reports, Study Report Amendments, SOPs, IOPs, EOPs and other documents.
  • Maintain copies of approved Study Plans and SOPs.
  • Planning/scheduling of inspections/audits.
  • Audit of study raw data and study report.
  • Conducting facility based inspections in all the GLP areas.
  • Review of Change controls, Deviations, CAPA and creating audit plan in Electronic Quality Management System
  • Report the observations/findings of inspections to the respective auditee and management in a timely manner.
  • Updating the issues/concerns and non compliances to Head QAU.
  • Preparation and issue of Signed QA statement for Study Reports.
  • Verification of QA activities weekly/monthly.
  • Preparation of Quality Analytics report related to physical chemical Bioanalytical studies.
  • Impart GLP compliance training to the personnel working in the GLP area.
  • Submission of records relevant to QAU for archival in a timely manner
  • Updating the issues/concerns and non-compliances to Head- QAU and management
Educational Qualification: M.Sc., / M. Pharm with minimum 2 + years of working experience with Pharmaceutical / Life science.Technical/functional Skills: Hands on Experience in LMS, Track wise and EDMS.Experience: 0-3 yearsBehavioral Skills:
  • Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
  • Good speaking-listening-writing skills in english, attention to details, proactive self-starter.
  • Ability to work successfully in a dynamic, ambiguous environment.
  • Ability to prioritize workloads.
  • Ability to develop new ideas and creative solutions.
  • Should able to work in team and flexible for working in shifts.
  • Should be a focused employee.
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 :
quality assurancesalescommitment towards workequal employment opportunitymisdeliverycontinuous improvement facilitationstudy reportsconsumer goodscustomer servicecustomer relationsanimal health

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