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Junior Manager - Injectables

8.00 to 12.00 Years   Delhi   20 Feb, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

    Responsible for operating machines, documentation, upkeep, facility maintenance, cGMP compliance for production and packaging operations at formulation manufacturing facility for human injectable dosage forms. Primary responsibilities:
    • Equipment setup, operation, dismantling and cleaning of manufacturing and packaging equipment and instruments in injectable facility and execution of manual operation like unit preparation and Lyo loading.
    • Co-ordination with supervisor or scientist while manufacturing of batches, performance qualification of equipment for existing and new equipment.
    • Daily logbook entries, verification of instrument as applicable.
    • Daily, weekly, and monthly Balance verification and calibration.
    • Entries in batch records, protocols, relevant equipment usage logbooks.
    • Co-ordination with cross functional department for completion of production targets and support for achieving of production numbers for weekly, monthly and annually
    • linen management - cleaning, storage and inventory of garments as per SOP.
    • Perform identification, assessment and categorization of consumables.
    • Co-ordination with engineering and maintenance team during preventive maintenance of equipment.
    • Daily monitoring of environment monitoring system.
    • Equipment, Instrument and area cleaning record and checklist update.
    • Complete online and offline training on time.
    • Support for preparation of SOP, EOP and IOP as applicable in EDMS as well as manually.
    • Support for area validation, qualification and equipment qualification and re-qualification.
    • Supporting for department for audit preparation and monitoring.
    • Support in implementation of cGMP requirements to meet compliance w.r.t. USFDA, EU, MHRA standards.
    • Support in preparation of various client visits, regulatory and QP audits.
    Secondary Responsibilities:
    • To ensure and implement procedures to target Zero Incidents.
    • To ensure proper Housekeeping.
    • Facility readiness during audit/visit.
    Quality Compliance: Compliance and Adherence to all applicable Syngene Quality Systems EHSS Compliance Compliance to Syngene EHSS Policies and Systems. Educational Qualification: BPharma Experience: 8-12 years Behavioral Skills:
    • Good communication,
    • Quick learner,
    • Adapt to changes,
    • Time management,
    • Professionalism.
    • Effective Planning and Organizing skills.
    • Good Business/Industry Awareness.
    ,

Keyskills :
troubleshootingclient visitsmechanicalsapcommissioningdata management

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