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Assistant Manager

9.00 to 12.00 Years   Delhi   04 May, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    This role is for the Engineering and Maintenance of the Formulation facility maintenance. It will support the engineering team in maximizing organizational performance levels and competency in aligning with quality and safety standards.This role ensures timely execution of preventive maintenance, breakdown maintenance, and upkeeping of utility equipment & systems like; HVAC system, Purified water plant, WFI, Pure steam, Chillers, Air compressors & Cleanroom equipment. And also responsible for handling quality management systems like CAPA, CCF, Deviation investigation, and compliance with regulatory requirements.Key Responsibilities:
    • Coordination with the cross-functional team for installation and commissioning of Utility & HVAC equipment and knowledge of process equipment (Injectable & OSD facility equipment).
    • Preparation and review of equipment qualifications (HVAC, Purified water, WFI, and Pure steam).
    • Root cause analysis and corrective action plan for variances in operational performance of utility equipment and energy saving.
    • Adherence to Standard Operating procedures, Safety, cGMP, QMS & EHS Requirements.
    • Preparation of SOPs related to Utility & HVAC equipment operation and preventive maintenance.
    • Preparation and execution of qualification protocols related to HVAC and utility equipment.
    • Planning and execution of preventive maintenance of HVAC equipment & facility in coordination with the user.
    • Coordination with OEM for regular PM visits and breakdown maintenance of utility equipment.
    • Planning and procurement of required spare parts for the equipment and its accessories.
    • Clean room equipment preventive maintenance and its documentation.
    • Participate in small projects/modification initiatives.
    Educational Qualification: B.E/B. TechTechnical/functional Skills:
    • Hands-on experience in routine and breakdown maintenance of Clean Utilities (Purified water, WFI & Pure steam) and HVAC equipments.
    • Electrical systems, Chillers, Heat pumps & knowledge of formulation Injectable/ OSD equipment.
    • Experience in QMS handling (CAPA/CCF/Deviation writing skill)
    • Experience on SAP
    • Experience on Trackwise
    • Experience on EDMS
    Experience: 9-12 years of relevant experience ,

Keyskills :
salesmisaccountstatbankingservice center operationsstandard operating procedures

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