Sr, Executive USP

Designation: Executive/Sr. Executive

Job Location: Bangalore

Reporting to:

Job Grade: Executive

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. Syngenes 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:

• Follow good aseptic behavior inside Biologics operations facility.
• Perform all the upstream activities like Assembly preparation Media Preparation Vial thaw Feed preparation and filtration Bioreactor Operations to Batch Harvest.
• Monitoring and process control of the specific Operations of the upstream.
• Maintenance of Quality records.
• Traceability from raw material till finished product.
• In-process product sampling and storage.
• Preparation and review of operation related documents.
• Perform room owner responsibility for the assigned USP area.
• Perform equipment/instrument ownership related responsibilities related to USP.
• Initiate Complaint Slips (work orders) for USP related areas and equipment.
• Coordinate with QA for line clearance.
• LNS system monitoring and LN2 tank refilling.
• Gas Bank Monitoring.
• Maintaining process area All-time ready for Inspection/ audit purpose.
• Preparation of general upstream related procedures protocols risk assessment and BMRs.
• 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 nonconformity to the supervisor.
• Issuance of annexures RM consumables and BMRs.
• Tracking of work order status and ensuring timely closure.
• Involve in downstream related activities under supervision of downstream supervisor.

Education and Experience

Education

Masters degree/ bachelors degree in pharmacy Masters 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

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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