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Deputy Manager Injectables Manufacturing

12.00 to 15.00 Years   Delhi   09 Feb, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

    Deputy Manager, Formulation Injectables The role is responsible to supervise manufacturing of Parenteral injectable manufacturing and packing. Experience in vial filling machine & Lyophilizer for ready to use vials and ready to use prefilled syringes. Key Result Areas Role-specific:
    • Managing production team involved in day to day operations of parenteral products.
    • Responsible for support to plan for manufacturing and packing of Injectable manufacturing facility for small molecules formulations & large molecules (biologics) products.
    • Responsible for ensuring compliance of QMS activities like change control, Deviation, Investigations, OOS, OOT, market complaints, validation protocols, CAPA, APQR as per need.
    • Implementation of documentation systems such as Standard operating systems, operational & Equipment operating procedures, BMR, BPRs.
    • To ensure training and good clean room practices according to the regulatory guidance.
    • Having experience on WFI generation & distribution system and guide the team.
    • Co-ordinate with other functions like project management, Formulation Development, Regulatory, QA & QC with respect to various plant related activities.
    • Effectively manage the manufacturing activities & resources for smooth functioning and ensure that facility is in state of compliance with cGMP requirements.
    • Participate in periodic self-inspections/internal audits/client and or regulatory audits.
    • Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
    • Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
    • Attend training on Environment, Health, Safety, and Sustainability (EHSS)
    Education and Experience Education
    • B. Pharm / M. Pharm with minimum 12 years of work experience in managing manufacturing of Parenteral formulations.
    Industry Experience 12-15 years of relevant experience Other competencies required for the role
    • Should have experience for manufacturing of Parenteral formulations technology and support for manufacturing of clinical supplies.
    • Should have hands of experience for operation of Vial filling line for liquids and lyophilized products, PFS filling line and Cartridge filling line.
    • Should have knowledge and experience for transfer of technology from development scale to pilot scale.
    • Should have faced regulatory inspection like USFDA, EU GMP, MHRA etc.
    • Should have hands of expertise in qualification activities like URS, FAT, DQ, IQ, OQ, PQ of equipment/instrument for small volume parenteral and sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc.
    ,

Keyskills :
miscustomer servicedocumentationfinanceinsuranceequal employment opportunitycontinuous improvement facilitationanimal healthconsumer goodschange control

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