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DSP Operator
Syngene International
posted 1 day ago
Job Role Insights
Flexible timing
Job Description
Designation: Associate
Job Location: Bangalore
Reporting to:
Job Grade: Associate
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and 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. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Key Result Areas
Role-specific:
- Maintain good aseptic behaviour inside Biologics operations facility.
- Perform all the Downstream activities like Assembly preparation, accessories arrangement for step, Dispensing of raw materials and consumables, Reconciliation of excess and unused raw materials and consumables Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation and 0.2 filtration.
- Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP.
- Monitoring and process control of the specific Operations of the Downstream.
- Maintenance of Quality records.
- Perform In-process product sampling, sample submission and storage.
- Preparation and review of operation related documents.
- Perform room owner responsibility for the assigned DSP area.
- Perform equipment/instrument ownership related responsibilities related to DSP.
- Initiate Complaint Slips (work orders) for DSP related areas and equipment.
- Coordinate with QA for line clearance.
- Maintaining process area All-time ready for Inspection/ audit purpose.
- Maintain facility and assigned zone all-time ready for visit and audit.
- Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record (BMR).
- Involve in shipment of samples / final product as per packing and dispatch record .
- Work proactively to meet all document(s) on time closure requirement.
- Preparation of general Downstream related procedures, protocols, risk assessment and BMRs.
- Execute the protocols related to Downstream related activity and equipment / instrument qualification.
- Involve in Shipment of samples /final product as per packing and dispatch record.
- Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required.
- Execute the batch activity as per BMR and report nonconformity to the supervisor.
- Review of executed Documents on time.
- Issuance of annexures, RM, consumables and BMRs.
- Track the work order status and ensuring timely closure.
Involve in upstream related activities under supervision of upstream supervisor.
Education and Experience
Education
Master s degree/ bachelor s degree in pharmacy, Master s degree in Pharmaceutical Sciences.
Industry Experience
- Minimum 1 -4 years of relevant practical experience in mAbs downstream process.
Other competencies required for the role
- Follow the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment and adhere to the highest standards of quality, integrity & compliance for every work activity.
- Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar.
- Attend all assigned mandatory trainings related to data integrity, health, and safety measures.
- Compliance to Current Good Manufacturing Practices and Good Documentation Practices.
- Adherence to Standard Operating procedures, Operational control Procedures.
- Participate in & support the trainings on procedures, protocols, and On-the-Job activities.
- Follow the discipline of reporting structure at times of escalation.
- Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
- Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.
Safety
and DI Responsibilities:
- Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security.
- Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety.
- Understand all necessary safety protocols and always follow the same to ensure safety for all.
- Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals.
Equal Opportunity Employer
.
Pls visit us at https://syngeneintl.com/ to know more about us and what we do.
Employment Type: Full Time, Permanent
Read full job description
What people at Syngene International are saying
Operator salary at Syngene International
reported by
4
employees
with 2-4
years exp.
₹2.7
L/yr - ₹4.4
L/yr
21%
more
than the average Operator Salary in India
View more details
What Syngene International employees are saying about work life
based on 2.1k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Syngene International Benefits
Submitted by Company
Cafeteria 
Health Insurance Job Training Team Outings
Submitted by Employees
View more benefits 
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Syngene International Bangalore / Bengaluru Office Locations
Bengaluru/Bangalore, Karnataka Office
Headquarter
Syngene International Ltd, Biocon Park, SEZ, Bommasandra Industrial Area – Phase-IV, Jigani Link Road, Bangalore 560099
Bengaluru/Bangalore, Karnataka
560099
560099
Bengaluru/Bangalore, Karnataka Office
Syngene International Ltd, Semicon Park, Tower 1, Electronic City – Phase-II Hosur Road, Bangalore 560100
Bengaluru/Bangalore, Karnataka
560100
560100
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