Associate Executive

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JOB DESCRIPTION

Designation: Executive

Level: 9- I

Job Location: Bangalore

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:

Functional Responsibilities:

• Responsible for safety compliance in all the work activities performed.
• 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 training courses in a timely manner and comply with the training procedure training calendar.
• Attend all assigned mandatory training related to data integrity, health, and safety measures.
• Compliance with Current Good Manufacturing Practices and Good Documentation Practices.
• Adherence to Standard Operating procedures, Operational control Procedures.
• Participate in support the training 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.
• 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.

Primary Responsibilities:

• Maintain good aseptic behavior inside BMP1 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 Downstream.
• Maintenance of Quality records.
• Perform In-process product sampling, sample submission and storage.
• 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.
• 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.
• Execute the batch activity as per BMR and report nonconformity to the supervisor.
• Issuance of annexures, RM, consumables and BMRs.
• Track the work order status and ensure timely closure.

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.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.