Job Description

Division
Department
Sub Department 1
Job Purpose
The incumbent supports the Operations and Engineering teams on improving the process along with providing advanced technologies for enhancing the productivity. He also provides technical support for process validations and helps the site in all regulatory compliances.

• Process Design and Optimization: Develop and implement manufacturing processes for sterile pharmaceutical products to ensure product and process Robustness
• Technology Absorption: Provides guidance to process team on new technologies to be adopted and ensures smooth transfer of the same
• Process Validation: Provides support for all validation related activities of key equipments and participates in root cause analysis and CAPAs for any deviations observed
• Technical Support xc3xa2xc2x80xc2x93 Provides technical assistance in all sterile operations and processes .
• Compliance: Ensures that the unit is compliant to all regulatory requirements at all times

Key Accountabilities (1/6)
Process Design and Optimization

• 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.

Key Accountabilities (2/6)

• 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

Key Accountabilities (3/6)
Technology Absorption

• 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

Key Accountabilities (4/6)
Process Validation

• 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

Key Accountabilities (5/6)
Technical Support

• 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.

Key Accountabilities (6/6)
Compliance

• 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 nonconformances. Providing appropriate CAPAs as applicable.
• Participate in Audit trail review and Equipment/System User management review.
• Provide support in review of BMR and BPR

Major Challenges

• Process Validations, Parameters to meet rapidly evolving regulatory guidelines.
• Performance of old assets to meet stringent process requirements as per guidelines
• Gaps in SOP vs Regulatory Guidance
• Capability of Personnel
• Attrition of Critical Talent

Key Interactions (1/2)

• IPD,EM&R and A&IR-For technology transfer and process implementation and optimization
• Safety for safety operations and near-misses
• Indirect purchase for Spares, scope, insurance and new vendors
• Central purchase for provide Technical inputs and clarifications for CAPEX (Need basis)

Key Interactions (2/2)

• OEMs for projects, automations, alternate vendor development, quality issues and maintenance (Need basis)
• Auditors and Consultants for audits and compliance

Dimensions (1/2)

• Dotted line Reports: Production team

Dimensions (2/2)
Key Decisions (1/2)

• Decisions related to Gap Assessment vs Regulatory Guidance
• Decisions related to new product design and optimization
• Decision related to new technology adoption
• Decisions related to Audit Compliance

Key Decisions (2/2)
Recommend structures and implement structures so that process is implemented as per design.
Education Qualification
BE/B-Tech
Relevant Work Experience
12-15 years of Experience