Applicants for-Production Executive

Job Description

Designation: Executive Job Location: Bengaluru, India Reporting to: Associate Manager, Pharmaceutical Development Job Grade: 9 Operating Unit: Biopharmaceutical Department: Biopharmaceutical Operation The Company Syngene 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 Role The role is responsible for upstream activities like Assembly preparation, Media Preparation and handling Bioreactor Operations to Batch Harvest. Key Result Areas Role-specific:
• Adherence to all procedures related to data integrity.
• Ensure there is no violation of any environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Escalate safety related incident through appropriate channel.
• Wear all required PPE at all times.
• Understand and demonstrate that you are responsible for safety of self & colleagues by following all necessary safety protocols at all times.
• Identify near-misses and potential incidents proactively and communicate those.
• Attend all assigned mandatory trainings related to upstream, data integrity, health, and safety measures.
• Follow the discipline of reporting structure at times of escalation.
• Compliance to Current Good Manufacturing Practices
• Adherence to Standard Operating procedures, Operational control Procedures
• 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
• Following good Aseptic behavior inside BMP1 Facility
• 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 non-conformity to the supervisor.
• Issuance of annexures, RM, consumables and BMRs.
• Tracking of work order status and ensuring timely closure.
Education and Experience M.Sc/B.Tech(1-3 years) of relevant experience 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 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 :
qualityproduction planningdocumentation