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Urgent profile for-QC Senior Manager

4.00 to 6.00 Years   Kolkata   10 Dec, 2022
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    • Senior Manager QC Operations is responsible for testing and release activities of Biologics at Syngene International Limited.
    • Senior Manager QC Operations will report to the Head of Quality Control Biologics and act as a delegate to the Head of Quality Control Biologics in the latter s absence.
    • Senior Manager leads the operations in QC Biologics (Drug substance and Drug Product) related to the following areas;
    • In-process testing and release
    • Final Product testing and release
    • Stability testing
    • Method Validation and Transfers
    • Senior Manager shall be responsible for GMP and GLP compliance and other regulatory requirements in QC lab.
    • Senior Manager QC Operations shall collaborate with other stakeholder like Program Management, Strategic Sourcing, Manufacturing, Engineering and Maintenance, EHSS, Quality Assurance, Analytical Development to ensure successful project deliverables and milestone accomplishments.
    • A team of approximately 40 members report to Senior Manager QC Operations
    • Senior Manager QC Operations is responsible to ensure all KPI s are met related to project timelines for QC testing portion. He/She shall ensure work plans are periodically updated to address any changes in scope, priorities or timing.
    • Participate in functional and cross functional teams and ensure testing of Biologics products as per cGMP compliance.
    • He/she shall always adhere to ALCOA principles on data integrity as applicable for work area for self and team
    • Establish robust governance process for effective review of the function and escalate key concerns to the senior leadership in formal and timely manner.
    • Responsible to investigate any deviation, Incident, OOS, OOT, client complaints related to QC testing in Biologics and assess the impact on product quality and propose and implement remedial actions to prevent such occurrences.
    • Responsible to participate in investigation and closure of client and regulatory audit observations in QC Biologics.
    • Provide QC representation for regulatory filing wherever required (e. g. Prior Approval Submissions, renewals/updates/supplements etc.), Ensure timely update of Annual Product Review (APR/PQR) for Biologics QC batch release sections.
    • Manage, coach and develop QC team and contribute to their growth. give directions and monitor team activities to deliver excellence.
    • Proactively monitor various Quality control trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements within QC Biologics.
    • Shall identify continual improvement opportunities in various work areas of QC Biologics and ensure implementation of the same.
    • Shall participate in assessing the continues state of regulatory compliance in SOP s and ensure timely updates or revisions to procedure.
    • Preparation of capital and revenue budgets, manpower projection requirement on a yearly basis.
    • Recruit, induct and integrate associates into Syngene system.
    • Responsible to meet project timelines related QC Biologics operations. Ensure work plans are periodically updated to address any changes in scope, priorities or timing.
    • Establish robust governance process for effective review of the function and escalate key concerns to the senior leadership in formal and timely manner.
    • Any other responsibilities that may be assigned by Head Quality Control Biologics and/or Senior Management.
    ,

Keyskills :
financeaccountancyquality controlsalesquality assurancedata integrityproduct testingmis

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