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Junior Manager Quality Control Biologics 1

9.00 to 12.00 Years   Chennai   09 Dec, 2022
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    • To handle the Inprocess and Finished products team as shift in charge.
    • Review of Analytical documents related to Inprocess/Finished products/Stability/Method validations.
    • Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
    • Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
    • Handling Internal audits, Client audits and Regulatory Audits pertaining to Biologics Operations Unit.
    • Coordinate for Internal Audits in consultation with Internal Quality Audit Team as per the schedule.
    • Coordination with cross functional departments on the status/ progress of Audit related CAPA on a weekly basis.
    • Tracking follow- up and closure of CAPAs triggered through external audits, internal audits and self-inspections. Provide data and updates on the same to Internal Quality Audit team on a monthly basis.
    • Ensuring all time audit readiness and preparation prior to audits.
    • Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
    • Provide data on status of audit related CAPA progress/closure for Quality Governance Forum.
    • Assessment of FDA 483 observation reports and regulatory guidelines against current systems in Syngene.
    Key Responsibilities:
    • Handling shift and ensuring release of Inprcoess/Finished product samples within TAT and by adhering to compliance norms.
    • Review of Analytical documents related to Inprocess/Finished products/Stability/Method validations.
    • Guidance to the analysts on good laboratory and analytical procedures.
    Educational Qualification: Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering Technical/functional Skills:
    • Knowledge on Biologics Manufacturing and testing compliance requirements.
    • Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
    • Tactful communication.
    Experience: 9-12 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.
    ,

Keyskills :
equal employment opportunityquality controlinternal quality auditorcalibrationisoinspection

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