skillindiajobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Junior Manager AQA

7.00 to 9.00 Years   Kolkata   14 Dec, 2022
Syngene International Limited
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaNetwork / System Administration
EmploymentTypeFull-time

Job Description

    • Ensure readiness for internal and external audits by periodic GMP rounds.
    • Issuance of logbooks and annexures for execution, review of executed logbooks and annexures.
    • Handling and management of Analytical QA pertaining to Biologics.
    • Handling of customer projects and attending internal PRM to ensure the project related activities are delivered as per timeline.
    • Review and approval of documents related to CSV, LIMS, over all qualification activity, protocols, reports etc.
    • Review and approval of the analytical testing records.
    • Review and approval of Analytical Method Validation, Analytical Method Transfer, protocol and report as per current SOP.
    • Review and approval of stability summary and stability reports generated by QC.
    • Handling and being part of the investigations related to Deviations, Laboratory Incidents, Out of Calibrations, Out of Specifications, CAPA and Out of Trend.
    • Handling & management of Deviations, Laboratory Incidents. Coordinating in identifying the root cause investigations with CAPA identification, approval.
    • Handling, review, evaluation of Change Control, verification, and implementation of the Corrective and Preventive Action.
    • Review of IOPs and EOPs in QCB.
    • Conducting regular GMP rounds in the Quality Control laboratory.
    • Review and approval of Equipment/Instrument Qualification documents related to QCB.
    • Review, approval of RM/PM/Consumables analysis reports and release on SAP.
    • Review and approval of stability summary and stability reports generated by QC.
    • Handling of Track wise activities as a QA Reviewer related to CAPA, Change Control, Deviation and OOS
    • Review of facility, process and EHSS risk assessment.
    Key Responsibilities:
    • Responsible for Quality Assurance activities pertaining to Biologics manufacturing unit (Analytical Quality Assurance activities of Biologics Quality Control).
    Educational Qualification: Master of Pharmacy / B. Pharm / Master of Technology -Biotechnology Technical/functional Skills:
    • Knowledge on Biologics Laboratory Instrument working, testing & compliance requirements.
    • Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
    • Hands on Analytical Techniques
    Experience: 7-9 years of experience in Biopharma manufacturing/testing/compliance/Quality Assurance. Behavioral Skills:
    • Analytical and problem solving
    • 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 :
sapsafetycommissioningmechanicaltroubleshootinganalytical method validation

APPLY NOW

Junior Manager AQA Related Jobs

© 2020 Skillindia All Rights Reserved