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Associate Manager- QA Biologics

2.00 to 7.00 Years   Pune   21 Jun, 2021
Syngene International Limited
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Designation: Associate ManagerJob 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.

  • Review and approval of master batch records (BMR/BPR/PDRs) of various projects
  • Approval of Bill of materials in SAP.
  • Issuance of batch numbers and batch records for execution.
  • Review of executed batch records and supporting raw data.
  • Review and approval of process validation, cleaning validation and hold time protocols and reports.
  • Client communications for batch release timelines.
  • Approval of Technology transfer documents
  • Preparation and review of quality protocols and quality agreements
  • Review and Approval of BMP SOPs.
  • Attending project review meetings and Telecons for projects and ensuring that the timelines provided for quality related queries are met.
  • Review and approval of product quality reviews.
  • Handling of change controls, deviations, CAPA and risk assessment related to batch release (logging, assessment and approval).
Key Responsibilities:Responsible for the BDR function of the Biologics business unit.Educational Qualification: Master of Science / Master of Technology -Biotechnology/Bioprocess EngineeringTechnical/functional Skills:
  • Knowledge on Biologics Manufacturing and testing compliance requirements.
  • Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
  • Tactful communication.
Experience: 10-12 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.
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 :
customer relationssalesmisanimal healthqualitycontinuous improvement facilitationmanagementbill of materialsconsumer goodsbatch releasebatch recordsequal employment opportunity

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