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Senior Executive-CD-Operations

3.00 to 6.00 Years   Bangalore   10 Jun, 2021
Sygene
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

Designation: Senior Executive, Chemical DevelopmentJob Location: Bengaluru, IndiaReporting to: Senior Manager, CD-OperationsJob Grade: 9Operating Unit : Chemical DevelopmentDepartment: CD - OperationsThe CompanySyngene 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.The RoleThe role is responsible to facilitate quality operations of all the equipment s and instruments at all Process Research & Development laboratories. The role would also ensure 100% compliance on regulatory and quality/training requirement associated with the same.Key Result AreasRole-specific:

  • Evaluate the current lab equipment and instruments and its asset status.
  • Up to date on the all the operational documents and procedures directly or indirectly related lab instruments or equipment.
  • Track and monitor capacity, resource utilization as a diagnostic control.
  • Regular monitoring of preventive maintenance of instrument and break down assistance.
  • Regular quality and compliance audits both Internal/external, corrective & preventive action closure.
  • Close monitoring of Infrastructure project progress against the plan and resolve critical bottlenecks and capex forecasts.
  • Active involvement in implementation of regulatory and safety compliance programs and best practices.
  • Good in quality documentation and communication.
  • Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
  • Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
  • Attend training on Environment, Health, Safety, and Sustainability (EHSS)
Education and ExperienceEducationMaster s degree in ChemistryIndustry Experience3-6 years of relevant experienceOther competencies required for the role
  • Experience in handling Process Research & Development instruments and equipment s.
  • Experience of working in chemical lab
  • Excellent communication (Oral and written)
  • Good Knowledge on regulatory and quality compliance in terms of equipment/ instrument.
  • Knowledge on API and requirement; Food and Drug Administration, International Organization for Standardization(ISO), Pharmaceuticals and Medical Devices Agency (PMDA) and other European regulatory bodies & 21 Code of Federal Regulations (CFR) part-11 compliance and its requirement with respect to instruments.
  • Knowledge/hands on experience on the various application software for quality and compliance, like electronic document management system(EDMS), Laboratory Information Management System(LIMS) and Trackwise etc.
Equal Opportunity EmployerIt 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 operationsfederal regulationssalesquality compliancepreventive actionmisdeliverycustomer servicesafety compliancedocument managementelectronic documentcustomer relationscode of federal regulations

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