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Associate Manager

3.00 to 4.00 Years   Ahmedabad   11 Mar, 2020
Sygene
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Primary Responsibilities:

  1. Responsible to prepare and review the method transfer, method verification & validation protocols.
  2. Coordinating and supporting the execution, review and release of method transfer, validation and verification activity and its records and results.
  3. Assisting in the technical aspects of the change control, CAPAs, and test methods reviews and revisions and assisting to resolve laboratory incidents, out of specification (OOS), complaints, discrepancies and CAPA.
  4. Responsible for the managing of all activities related to product support in Quality control biologics.
  5. Shall participate in investigations, audits and inventory management, continuous improvement initiatives for all the projects.
  6. Review of daily/monthly laboratory monitoring, verification, calibration records of Equipment and instruments.
  7. Responsible to check and review all the new joiners training records and analyst qualifications.
  8. Coordinating and supporting the team for the preparation and review of QMS documentation such as SOPs, IOPS and EOPs.
  9. Responsible to check, update and review all the compliance documents on-time for the Equipment and instruments documents like calibration records/reports, log books, cold chamber log sheets.
  10. Responsible to prepare CAPEX and OPEX based on requirement.
  11. Implementation of LIMS product and stability modules in Quality Control Biologics.
  12. Responsible to train lab personnel in fundamental lab techniques and procedures as a mentor and coach. Shall initiate experiments as needed.
  13. Develop the competency matrix so that the staff are optimally utilized in the laboratory.
  14. Responsible to complete all planned quality and compliance training as and when required by the department Head.
  15. Responsible for attending the weekly teleconferences with clients and understand and establish requirements to meet and deliver their needs.
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Keyskills :
continuous improvementmanagement qualityinventory management compliance trainingcustomer relations product supportquality contro

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