Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Associate / Executive / Sr. Executive / Jr. Manager / Assistant Manager
Upstream (cell culture) - (52882)
Job Description :
• 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
• Execute all the upstream related activities including assembly preparation, feed and media preparation, gas bank management, take care of USP cleanroom upkeep, Bioreactor readiness and its operation, sample management and material dispensing.
• Maintain Compliance to cGMP practices and approved procedures.
• Perform all the upstream activities like Assembly preparation, Media Preparation, Vial thaw, Feed preparation and Filtration, Bioreactor Operations to Batch Harvest.
• Execution of protocols related to upstream related activity and equipment / instrument qualification.
• General consumable stock review and record maintenance
• Ensure PM planner and calibration planner are followed.
• Execution of batch activity as per BMR and report non-conformity to the supervisor.
• Issuance of annexures, RM, consumables and BMRs.
• Tracking of work order status and ensuring timely closure.
• Monitoring and process control of the specific Operations of the Upstream.
• Adherence to Standard Operating procedures, Operational control Procedures
• Compliance to Current Good Manufacturing Practices
• Following good Aseptic behavior inside BMP1 Facility
• Maintaining process area All-time ready for Inspection / Audit purpose.
Downstream (cell culture) - (53128)
Job Description :
• 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 (EHSS) mindset and operational discipline at the workplace always.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHSS) 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
• 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.
Required Skillset
• Expertise in downstream unit operations.
• Strong Hands-on experience with Chromatography and filtration.
• Exposure to handle of recombinant proteins and biotherapeutics projects in cGMP area.
• Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
• Experience on the Equipment Qualification and commissioning aspects.
Facility Management (Production) - (52023)
• 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 (EHSS) mindset and operational discipline at the workplace always.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHSS) requirements always 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
• Supervise cleaning & sanitization of the clean rooms and maintain or review the records.
• Operation and cleaning of sterilization Autoclave and Deacon Autoclave.
• Preparation of disinfectant solution and ensure appropriate documentation.
• Report non-conformities and participate in implementation of corrective and preventive action.
• Review shop-floor documentation and ensure Good Documentation Practice(s).
• Ensure adherence to Standard Operating Procedures.
• Should be ready to work in all shifts
• Supervise cleaning & sanitization of the clean rooms and maintain or review the records.
• Operation and cleaning of sterilization Autoclave and Deacon Autoclave.
• Ensure waste management as per established procedures.
• Report non-conformities and participate in implementation of corrective and preventive action.
• Review shop-floor documentation and ensure Good Documentation Practice(s).
• Ensure adherence to Standard Operating Procedures.
• Perform fumigation as per the schedule
Candidate Profile
Diploma / BSc / Btech / MSc / MTech / M.Pharma with 1 to 12 Years of Experience
Job Location : Bangalore
Walk in Interview
Date & Time : 17th December 2022, 10:00 AM to 2:00 PM
Venue : Minerva Grand Hotels, Bhuvana Towers, SD road, Kalasiguda, Secunderabad, Telangana 500003
Candidates need to get their latest resume, ID proof (PAN/Aadhar card), latest increment letter, and last 3 months pay slips.
OR
Apply on the below links
Facility Management (production)
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