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Manager-Regulatory Surveillance

5.00 to 9.00 Years   Chennai, Hyderabad, Kolkata   04 Jul, 2022
Sygene
Job LocationChennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    1. Responsible to perform surveillance of regulatory agencies (like USFDA, TGA, EU, MHRA, SAHPRA, Health Canada, WHO, ICH, PIC/s, etc.)websites and any other platform to identify updated regulatory guidelines, pharmacopoeia, non-conformances (FDA 483 s, warning letter, etc.) published.
    2. Responsible to evaluate and perform the gap assessment for the compliance to current regulatory guidelines, pharmacopeia updates, and non-conformance reports issued to other organisation to ensure the Syngene Systems are inline with current regulatory requirements.
    3. Monitor and track the gap assessment reports for closure and actions initiated as a part of regulatory surveillance activity for adequate and on time implementation.
    4. Review of learnings from audit observations, quality events and CAPAs identified across the organization and cross deploy to other Operating Units for proactive system improvements.
    5. To participate/ review the investigations, pertaining to the deviations, customer complaints, OOS, OOT, etc. as per role specified in respective procedures.
    6. Support to establish the Corporate quality system/policy/procedures in compliance with national/international regulatory standards.
    7. Ensure compliance with the observations of an internal, client, or regulatory audit and provide response or support for observation related Corporate Quality Assurance function and support operating units for audit compliance wherever required.
    8. Support the Quality Management Review Meetings as and when required.
    9. Ensure horizontal deployment of learning across all verticals of Syngene as a part of harmonized quality compliance.
    10. Work within an interdisciplinary research and manufacturing team and support in resolving compliance issues.
    11. Ensuring training compliance in line with training procedure.
    12. With effective communication presentation, inter-personal skills build network among the different vertical/Operating Units and coordinate with them from CQA front.
    13. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
    14. Any other assignments conferred by Reporting Manager after fulfillments of training requirements.
    ,

Keyskills :
corporate quality assurancecontinuous improvement facilitation

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