Lead Process (Manufacturing) - Sterile/Injectables

Role & responsibilities

• Design new processes and review existing Manufacturing process with focus on ensuring sterility by design to ensure Right first-time media fill
• Ensure scientifically sound cycle development for Sterilization processes like Autoclave, SIP etc
• Optimize existing processes to improve productivity, quality and cost-effectiveness
• Analyse process data to identify trends and areas of improvements
• Optimize warehouse processes right from receipt of raw material to finished product dispatch using lean techniques like 5S, Six sigma etc.
• Provide support in HVAC for meeting temperature/Relative Humidity requirements in warehouses and other areas.
• Review existing processes of Filling line like

a)Vial Washing-Vial Washing cycles using Recycled water, purified water, Water for Injection(WFI) and compressed air

b) Tunnel Sterilizer-Infeed zone(Drying zone),Hot zone and Cooling zone.

c)Vial Filling process-Transfer of aseptic load for filling. Nitrogen purging(Pre filling and post filling),Vial Filling and Stoppering

d)Lyophilization-Freezing, Primary Drying and Secondary Drying

• Provide inputs for improvements in area cleaning, Fogging activities and sanitization process
• Review trends and carry out analysis concerning viable and non viable counts.
• Devise strategies to ensure compliance to change room entry/exit procedures and gowning qualification.
• Ensure sterility/Integrity test of process by checking location of glove ports wherever interventions are involved
• Scientifically Evaluate any Technology being transferred to Manufacturing to ensure Quality & Manufacturability is built in by design
• Be part of Scale ups at manufacturing and work with IPD to ensure Robust Commercial Scale up of New Products
• Utilize Predictive tool and technologies (Modelling & Simulations) for Right First Time Commercial batches after filing
• Ensure right first-time media fill for new process transfers with deep review of aseptic connections and processes .
• Vendor Relationships / Management - Strengthen partnerships with key vendors to facilitate issue resolution, after sales support, etc
• Ensure right implementation of PUPSIT technology
• Be the Technical Expert for the unit for Process and Sterilization Validation and Aseptic Process Simulations (Media Fills)
• Support unit for Right First Time Process Validation using sound scientific validation principles
• Lead the validation of new processes, including the creation of validation protocols (PV)
• Scientifically evaluate Process Validation procedures for the unit and recommend changes to procedures if required to meet regulatory validation expectations
• Support technical trouble shooting during Process Validation/media fill activities, assist in identifying the root cause and defining CAPAs to prevent recurrence of the issue
• Lead implementation of New Validation tools and technologies at unit to improve validation Efficiency, Accuracy and Reliability
• Oversee technical aspects of major remediation activities (e.g. Revalidation etc.) arising due to regulatory or internal observations
• Provide technical support to manufacturing operations to resolve process related issues
• Support unit in resolving technical challenges in other processes like SIP, Depyrogenation, Autoclave/Steam steriliser etc..
• Develop and implement process monitoring systems to ensure ongoing control and compliance.
• Collaborate with A & IR team , process automation, equipment engineering, and other technical groups to optimize asset performance
• Provide technical support for area and equipment qualification
• Provide support in WFI and purified water sanitization aspects and carry out overall operation and maintenance review.
• Ensure all manufacturing processes comply with GMP (Good Manufacturing Practise) and other relevant regulatory requirements by design
• Participate in audits and provide necessary documentation and support.
• Provide SME support for regulatory actions and provide recommendations for process/procedure
• Support the Unit Operations in preparation of deviation investigation and compliance reports by reviewing the actions identified for observations and non conformances. Providing appropriate CAPAs as applicable.
• Participate in Audit trail review and Equipment/System User management review.
• Provide support in review of BMR and BPR