- 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
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.
