Job Summary 

We are seeking a Quality Assurance Associate for Microbiology for managing daily Environmental monitoring operations in the Manufacturing facility as well as in microbiology laboratory. The qualified individual shall ensure that cleanrooms and classified manufacturing environments meet microbial and particulate cleanliness standards through the design, execution, and oversight of the Environmental Monitoring (EM) Program. This role supports cGMP compliance by providing data on environmental conditions by proactively identifying the contamination risks.

Roles & Responsibilities

• Routine Monitoring Activities

• You will be responsible to perform Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs. 

• You will be responsible to perform Environmental Monitoring through LIMS software.

• Monitor different cleanroom areas including ISO5/Grade A, Grade B, C and D.

• You will be responsible to perform utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and Non-viable particulate load.

• You will be responsible for personnel monitoring as well as gowning qualification of personnel who will be proposed to work in cleanrooms.

• You will be responsible to perform water sampling (Raw water, treated water, Purified water, WFI and Pure steam) and to support the cross-functional department in area qualification /requalification.

• You will be responsible to maintain and calibrate EM equipment (e.g. particle counters, air samplers) and related required accessories.

• You will be responsible to train and qualify newly joined personnel in EM program and water sampling activity.

• Data Management & Trending

• Record and Review EM data accurately and in a timely manner.

• Perform routine trend analysis of viable/non-viable data and report anomalies.

• Participate in alert and action level excursions and support deviation management.

• Prepare the Annual summary report for EM program along with determination of Alert and Action level based on the historical data.

• Compliance and Documentation:

• Adhere to cGMP, GDP and internal SOP requirements.

• Prepare and review EM protocols, SOPs and investigation/ study reports.

• Support in regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans.

Scope/expectations:

➢ Full ownership and accountability for each project assigned

➢ Manage project delivery planner/tracker, issue trackers, PIS and any other updates needed and make sure 100% compliance to all the Ops processes

➢ Act as Ops coordinator to lead PPM with E2E Ops teams (Field team, QC, SUD), external partners like TCS, Toluna and go through all project specifications and checklists with CS SPOCs in PPM meeting appropriately

➢ Assist the Project Manager to plan, organize and control activities within own area of responsibility with efficient supervision to ensure timely, effective and efficient process execution through the proper supervision of staff as well as the strict implementation of project instructions and standards.

➢ Ensure ownership and accountability for all the tasks assigned on each project level as per project planner (post commissioning activities)

➢ Follow and assure 100% compliance to CI processes including internal and vendor partner QC checks norms.

➢ Follow and assure 100% compliance to all the SOPs standards

➢ Apply smart design at every project execution and assure that project is managed within the approved budget (OOP) with always adding even more efficiencies to produce more savings on each project level to achieve productivity targets

➢ Specs change/ alteration in the design or the questionnaire to be identified and actioned as per SOPs

Operation

▪ Plan, schedule and follow the E2E process within the area of operation with regular monitoring in order to meet the overall schedule, quality and client expectations of the assigned project

▪ Work closely with E2E Manager to clarify project related problems / issues in order to ensure that instructions are carried out correctly

▪ Ensure efficiency in operations by regular review / revisions of systems and procedures with the end goal of improving productivity in the department and report to project manager timely

▪ Achieve delivery schedules within ongoing emphasis to improve efficiency, accuracy, timeliness and cost effectiveness

▪ Assist in the preparation of quotations and costing for new projects, when asked for

▪ Ensure project plans / schedules / issues are communicated with other related departments for further action planning

▪ Ensure timely generation of input and output validation reports from Data Science team

▪ Ensure each project is executed in line with approved budget (OOP), but also that further efficiencies are implemented in order to deliver on productivity (savings) at every project

▪ Ensure data and systems back-up are created and maintained

▪ Assist staff on technical problems regarding the area of operation

▪ Provide regular feedback on the operation concerns and issues to E2E manager

▪ Perform other related functions/tasks that may be assigned by CI Ops Leads

Data Collection

▪ Plan and organize field work in relation to project planner, schedule, allocating quota and research materials

▪ Follow and 100% comply to established CI processes

▪ Organize briefing to the vendor partner EIC and interviewer certifications to train them on specific project requirements. Relationship Management

▪ Work along with vendor SPOC for field supervision and monitor progress and quality of work to achieve project timelines and quality.

▪ Ensure timely action on the reports published on data anomaly and variation.

▪ Ensure that the vendor partner conducts line function checks to supervise and validate each supervisor and interviewer work through accompaniments, telephonic and personal backchecks. Administration

▪ Ensure proper distribution of information and implementation of company rules and regulations as well as policies and procedures

Structural Design Engineer is required to work on the predominantly Temporary structures design review, and Metro rail structures design in general, for the ongoing project. The successful candidate will continue to work and contribute to the STRUCTURES Business units, for the design of ongoing, upcoming metro rail design projects and on Railway structures design.

• Conduct thorough design reviews of Temporary structures, ensuring compliance with all relevant standards and regulations.
• Develop and execute complex structural designs for Metro rail projects, adhering to strict safety and quality standards.
• Collaborate with cross-functional teams to integrate structural designs with other engineering disciplines.
• Perform advanced structural analysis using industry-standard software such as STAAD and MIDAS.
• Prepare detailed technical reports and design documentation for internal and external stakeholders.
• Contribute to the continuous improvement of design processes and methodologies within the STRUCTURES Business unit.
• Mentor junior engineers and provide technical guidance on structural design principles and best practices.
• Conduct site visits to assess structural integrity and provide expert recommendations.
• Participate in client meetings and presentations to communicate design concepts and solutions effectively.
• Stay abreast of the latest developments in structural engineering, particularly in the context of Metro and Railway structures.
• Ensure all designs meet project deadlines and budget constraints without compromising on quality or safety.
• Collaborate with the quality assurance team to maintain the highest standards of structural integrity in all projects.