Junior Executive - Facility Management

Job Description

Designation: Junior Executive, Biopharmaceutical OperationsJob Location: Bengaluru, IndiaJob Grade: 10Operating Unit : BiopharmaceuticalDepartment: Biopharmaceutical OperationsThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), 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. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The RoleSupervise the cleaning, fumigation activities in the facililty. Operating the Sterilization autoclave, Filter integrity machine, Garment cubicle, CLAF, Pass-boxes, Washing machine & Drying machine.Key Result AreasRole-specific:
• Operation and Supervision of Sterilization Autoclave, Decontamination Autoclave, Pass-boxes, Garment cubicles & CLAF S related to facility.
• Preparing daily routine facility cleaning disinfectant solution and ensure appropriate documentation.
• Supervise cleaning & fumigation of the clean rooms in the facility.
• Maintaining all the records and documents as per the GMP requirement.
• Ensure daily availability of all the required materials in clean rooms (Gowns, gloves, disinfectants etc.) as per the Standard Operating Procedures.
• Ensure Waste management as per established procedures.
• Preparation of qualification documents as per the present qualification procedure.
• Monitoring and performing the routine Fumigation activity.
• Coordination with cross functional team for qualification document review and approval.
• Execution of qualification activities as per the present qualification procedure
• Preparation and revision of SOPs related to facility and process equipment s.
• Qualification, Requalification and Validation of Sterilization Autoclave, EMS and Clean Room Equipment.
• Preparation and revision of Forms and checklists and associated written documents in operations.
• Compliance to current Good manufacturing practices and keep facility readiness at all the times as per regulatory requirements.
• Maintenance of quality records.
• Adherence to Standard Operating Procedures, Operational control procedures
• Verification of operations equipment calibration.
• Adherence to pollution control and safety requirements.
• Meet training requirements
• Ensuring readiness of prerequisites for batch activities
• Execution of BMP4 manufacturing operations by adhering Syngene safety and GMP practices.
• Coordination with PPIC team for Material request and requirements.
• Review of Environment monitoring data, online Environment monitoring trends reports and associated documents as per the SOP.
• Responsible for accompanying the CFT internal audits and closure of observations within the timeframe as per the approved procedure.
Education and ExperienceEducationB.ScExperience0-3 yearsFunctional or Technical skills RequiredAutoclave operation / garment management / Cleaning & Fumigation of clean room.Equal Opportunity EmployerIt 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.Please visit us at https://syngeneintl.com/ to know more about us and what we do.,

Keyskills :
accountingequal employment opportunitymisaccountssalesstandard operating proceduresinternal audit