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Executive- IPQA

0.00 to 3.00 Years   Delhi   01 Dec, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaAudit
EmploymentTypeFull-time

Job Description

  • Review of manufacturing documents (SOPs, EOPs, IOPs and Technology transfer documents) pertaining to Biologics function.
  • Review of master batch records and executed batch records (BMR/PDR).
  • Review of process validation, cleaning validation and hold time protocols/reports.
  • Line clearance for batch to batch and product to product changeover.
  • Ensure that good aseptic practices are followed inside the facility.
  • Review of facility, process and EHSS risk assessment.
  • Ensure readiness for internal and external audits by periodic GMP rounds.
  • Issuance of logbooks and annexures for execution, review of executed logbooks and annexures.
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.
,
  • Review of manufacturing documents (SOPs, EOPs, IOPs and Technology transfer documents) pertaining to Biologics function.
  • Review of master batch records and executed batch records (BMR/PDR).
  • Review of process validation, cleaning validation and hold time protocols/reports.
  • Line clearance for batch to batch and product to product changeover.
  • Ensure that good aseptic practices are followed inside the facility.
  • Review of facility, process and EHSS risk assessment.
  • Ensure readiness for internal and external audits by periodic GMP rounds.
  • Issuance of logbooks and annexures for execution, review of executed logbooks and annexures.
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.
,

Keyskills :
equal employment opportunitycontinuous improvement facilitationanimal healthbatch recordsexternal auditconsumer goodsquality assurance

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