Sumit Gupta

Ø Providing Technical support

· Create, develop, and update standard operating procedures, specifications, and other best practices documents to support standard services

· Develop training material to support the introduction of new services and new/ updated standard operating procedures

· Address specific technical support requests

· Develop and perform ongoing maintenance of knowledge databases / information repositories to share technical expertise

· Identify and support qualification of subcontractors for Labs Services.

· Act as a technical and quality consultant to improve practices and throughput in the global Labs Services

Ø Coordinating Technical Enhancement Projects globally - throughout all the regional Labs Services – with a LEAN approach.

· Manage the projects and their different aspects: time and planning, cost, communication

· Design experiments, internal studies and qualification studies whenever appropriate – prepare protocols, discuss these with project stakeholders

· Follow up on execution and review results

· Formalize output in technical documents: specifications, standard operating procedures. Support marketing to update marketing documentation

Ø Regulatory Monitoring and Support.

· Monitoring regulatory requirements and recommendations, and industry standards and best practices. Providing recommendations to internal stakeholders if appropriate

· Assessing impact of changes and evolutions and defining VS positioning and policy accordingly

· Participating in regulatory and/or industry and/or customers and/or expert’s network

· Reviewing post-services regulatory queries answers provided by Ops and support them when needed – when beyond their experience and knowledge. Identifying trends and sharing these with appropriate teams

Ø Customer Support:

Responsible to provide support to key accounts, specifically those validation/service accounts in resolving customer issues with our services.

Ø Projects Planning

• Responsible for planning, coordination of Filter validation projects from Local and Global customers and supervision of all technical and operational activities and laboratory staff members.
• To plan, allocate and execute Filter Validation and Lab Activities on weekly, monthly, and Quarterly basis in accordance with customer committed timelines and simultaneously considering all process variables, analyst availability, inventory status and practical feasibility of the process.
• To handle all projects rescheduling and deviations from plan and to reallocate to meet customer committed timelines.

Ø Validation and Qualification activities

• To execute and monitor following of filter validation activities

§ Microbiological Testing (Bacterial Retention studies and Viability Studies).

§ Physical Testing (Product based Bubble point studies, Diffusion/Water Intrusion studies and Compatibility Studies).

§ Preservative Binding studies.

§ Development and implementation of testing strategies for customer projects with unique process variables.

• Protocol preparation and execution of Qualification activities for equipments like Autoclave, HVAC, LAF, and Incubators etc as per cGMP and international regulatory requirements.
• Protocol preparation and execution of Cleaning validation and water loop validation activities.
• Monitoring of calibration and preventive maintenance activities.

Ø Microbiological and Lab activities

• To establish facility (Microbiology lab and aseptic area) for filter validation activities as per cGMP and international standards.
• Optimization and validation of Sterility testing and Bioburden testing methods.
• Preparation, Standardization and execution of SOPs and specifications for following microbiological activities:

§ Biolog and MINI API analysis for bacterial and fungal identification.

§ Propagation of Culture, purity testing and Culture maintenance.

§ Media Qualification.

§ Environmental monitoring (Active/ Passive air sampling for viable organisms).

§ Surface and personnel monitoring.

§ Isolation and identification of Environmental isolates.

§ Purified Water and Milli Q Sampling and testing.

§ Documentation and review of results and trend analysis.

Ø Quality concepts and implementations

• To establish and implement in processes “ISO Quality System” including:

§ Formats and procedures for handling of Change control, Deviations, Incidents, OOS and CAPAs through Track wise.

§ Quality Documentation System.

§ Projects for Continual Improvement.

• Implementation of Good Laboratory Practices in Access Lab.
• Implementation of worldwide Services Policies and Procedures.
• Continuous Improvement projects for optimization of Lab specific processes.

Ø Customer Audits and Regulatory Queries

• To face customer audits and to respond Regulatory Queries from Various Regulatory agencies and Customers regarding Filter Validation Activities.

Ø Budgeting, vendor approvals and follow ups

• To develop and implement laboratory budget, including expenses for personnel, supplies, and capital expenditure.
• Vendor selections, approvals for lab inventories.

Ø Manpowerhandling and inter department communications

• To set and achieve performance targets for self and all personnel from the Laboratory group and handling skilled and unskilled peoples

Ø Trainings

• To qualify and Re qualify the Analysts for Execution of all Filter validation Activities.
• To train Lab group for Daily Lab Monitoring and Aseptic Area Handling.

To give training to customers on various aspects of Filter Validation during Filtration Schools

§ Responsible to provide support to key accounts, specifically those validation/service accounts in resolving customer issues with services.

§ Collect, collate, maintain, and distribute technical, competitive, and comparative information.

§ Prepares and reviews documents, reports and raw data packages.

§ Compilation, collection, documentation and maintenance of filter Validation and Qualification database.

§ Analysis of filter validation study results.

§ To ensure “quality” in processes, products, studies and services that are provided to the customers, through implementing quality concepts, audits and reviews with follow up plans.

§ Responsible to develop Lab specific plans.

§ Develops and implements testing strategies and program definition subject to alignment with the worldwide Access Services policies.

§ To set and achieve performance targets for self.

§ Develops and implements laboratory budget, including expenses for personnel, supplies, and capital expenditure.

§ Directs efforts of the laboratory in development of standards for lab work and development and validation of analytical methods.

§ QC inspection of the incoming samples.

§ Responsible for review of the respective protocols, reports & raw data for the Product Bubble point, Compatibility, Preservative Binding, Viability and Bacterial Retention tests.

§ Responsible for the preparation of trend analysis in the lab.

§ Responsible for planning, calibration & validation, and preventive maintenance schedule for the lab equipments.

§ Responsible for preparation and implementation of relevant SOP’s.

§ Implementing & maintaining quality management system

§ Implementing corrective & preventive action for the non-conformance including audit non- conformance.

§ To handle customer query in terms of Validation studies

§ To face customer audits and Closing of Audit points.