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Downstream Manufacturing-Cell Culture

6.00 to 12.00 Years   Chennai   16 Nov, 2022
Syngene International Limited
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Mandatory expectation for all roles as per Syngene safety guidelines
    • Overall adherence to safe practices and procedures of oneself and the teams aligned
    • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
    • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
    • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
    • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
    • Compliance to Syngene s quality standards at all times
    • Hold self and their teams accountable for the achievement of safety goals
    • Govern and Review safety metrics from time to time
    The Role Purpose of this role is supervisor at downstream manufacturing process at Syngenes manufacturing facility for Cell culture products 100L,500L and 2KL scale respectively Key Result Areas Role-specific:
    • Execution and Supervision of downstream manufacturing activities (Chromatography, filtration systems and preparation of downstream accessories).
    • Manage the team and plan daily downstream execution activities.
    • Active trouble shooting to minimize the various risks prior to execution and during execution.
    • Planning of raw material /consumables management for production campaign.
    • Maintenance of Operations equipment in coordination with Maintenance Department.
    • Monitoring of process efficiencies.
    • Reporting of non-conformities and implementation of corrective/preventive actions in specific areas of operation.
    • Adherence to pollution control and safety requirements.
    • Issue, Checking and Review of Operations documents.
    • Meet training requirements.
    • Preparation, revision and review of Batch Manufacturing Records.
    • Preparation of general validation protocols and report, Performance qualification documents.
    • Review of Quality Department Protocols related to Operations.
    • Reporting Deviations and Change controls from Operations to QA.
    • Investigation of Batch failures in Operations.
    • Review of written Batch records, checklists and associated written documents in Operations.
    • Preparation and review of Operations related documents.
    • Process equipment commissioning & qualifications.
    • Candidate should be ready to work in shifts
    • Ability to work in a team and willingness to work in shifts including night shiftsPossess 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 Master s in Biotechnology,

Keyskills :
equal employment opportunitycontinuous improvement facilitationcell culturebatch records

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