Lead Process (Manufacturing) - Sterile/Injectables

Cipla; South Goa District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Cipla is seeking a skilled specialist to design and optimize sterile manufacturing processes, focusing on sterility by design and robust validation. You will work on autoclave, SIP, and media fill validations, while applying Six Sigma and 5S principles to boost productivity and quality.

Responsibilities include process design reviews, data analysis, and cross-functional collaboration with quality, manufacturing, and engineering teams to ensure regulatory compliance and Right First Time

Qualifications

• Experience in GMP manufacturing, especially sterile processes.
• Ability to design and review sterilization and aseptic filling processes.
• Strong knowledge of validation principles and regulatory expectations.

Responsibilities

• Design new manufacturing processes with sterility by design focus.
• Review and optimize processes to improve productivity, quality and cost-effectiveness.
• Lead validation efforts for new processes and media fills in aseptic operations.
• Analyze process data to identify trends and areas for improvement.
• Support HVAC, cleaning, sanitization, and gowning procedures to maintain sterility.

Skills

Sterility by design

Autoclave

SIP

Six Sigma

5S Lean

HVAC

Process Validation

Media Fill

Aseptic Process Simulations

Job description

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
• 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

• 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