Job Purpose · Creating and tracking purchase orders (POs) for the G-PHAD third-party manufacturers (CMOs). · Ensuring GR entry with respect to the PO and payments are processed. · Coordinating with project teams and ensuring data accuracy in SAP. · Supporting process improvements and compliance with procurement systems like SAP S4 HANA and ARIBA. · POs reconciliation and Deviations management · Define and implement the process for E2E Subcontracting process for TRD NCE PHAD external manufacturing. · Ensure correctness of SAP vendor and customer master data · Coordination with PHAD Global Project Team/EPSM /SPP and SAP business lead for implement process (SAP/supply activities) improvement to serve business needs. Role profile description · Manage PHAD external purchase order (PO) requests via the TRD PO SharePoint platform. · Maintain a robust tracking mechanism for PO requests and provide timely updates to project teams. · Coordinate with project teams for service-related or external batch manufacturing activities and perform goods receipt postings in SAP. · Verify all PO line items and components in SAP by cross-referencing the CMO consumption sheet with NVTS SAP PO data. · Ensure accurate consumption posting in SAP of input materials in DP/PP batches based on the CMO consumption sheet. · Collaborate closely with global NVTS stakeholders including MDGM, TRD MDM, GCS, SAP super users, and the P2P/payment helpdesk team. · Create subcontracting, direct, and indirect PRs and POs in SAP. · Support internal and external audits and inspections. · Contribute actively to the creation, revision, and maintenance of Standard Operating Procedures (SOPs). · Execute SAP-related tasks to ensure accurate and complete data availability for downstream materials planning and supply processes. · Communicate effectively with project teams and support to maintain uninterrupted, high-quality supply operations. · Adhere strictly to established procedures for all SAP and supply-related activities. · Perform any additional supply-related tasks as assigned to the team. Key Performance Indicators · Task Execution: Timely, accurate, and reliable completion of assigned responsibilities within defined budgetary constraints. · Customer Satisfaction & Compliance: Delivery of solutions that meet high standards of customer satisfaction while ensuring full compliance with applicable regulations (e.g., GxP, SOX). · Adherence to Standards: Consistent alignment with Novartis standards, particularly in the areas of ethics, health, safety, and environment (HSE). Ideal Background Education & Technical skills (minimum/desirable): · bachelor’s degree in science, Commerce, Engineering, Business Administration, or a related field. · Desirable: Advanced degree with expertise in IT systems such as SAP S/4HANA and ARIBA. · Experience as an SAP Key User, preferably in one or more of the following modules: · MM (Materials Management) · FI (Financial Accounting) · PP (Production Planning) · WM (Warehouse Management) Languages: Fluent in English, both written and spoken. Experience/Professional requirement: 1. 3 to 8 years of relevant experience in a business support role, ideally within supply chain, SAP domains, or pharmaceutical/manufacturing organizations. 2. Over 3 years of hands-on experience in technical domains such as supply chain operations and SAP applications. 3. Proven track record in project and implementation management, with strong organizational and planning capabilities. Key competencies required: 1. Willingness to learn and adapt. 2. Strong troubleshooting and support engagement skills. 3. Proficiency in action plan tracking and issue resolution. 4. Effective team collaboration and communication. Show more Show less
The Data Quality Expert (DQE) is accountable for creating, maintaining, and optimizing dynamic master and reference data across global Analytics functions within TRD. This role ensures the accuracy, quality, and lifecycle management of data in digital systems, supporting business operations, governance, and decision-making. Key Responsibilities: Create and maintain global dynamic master and reference data. Support Line Units in transcription/setup of records in IT systems (e.g., LIMS, stability protocols). Coordinate with stakeholders for initiating/updating master data. Support global project teams and line functions on data object requests/changes. Collaborate with governance boards to maintain compliance and standards. Ensure timely updates of global and local master data across all TRD sites. Enhance end-user satisfaction through continuous support and training. Guide and educate users in best practices and key application usage. Optimize system performance and ensure robust IT system integrations. Provide coaching, mentoring, and technical expertise to team members. Promote a learning organization culture and share best practices. Monitor data quality regularly to ensure fitness for use and rule compliance. Produce Data Quality Dashboards as per defined business metrics. Analyse and act on data cleansing/enrichment requests from stakeholders. Enhance the Data Quality strategy, framework, and metrics. Design and implement cleansing and linking strategies. Develop and manage plans for data quality corrections. Work with Data Stewards, Process Owners, and Solution Designers for governance. Execute periodic DQ assessments, KPI tracking, gap analysis, and improvements. Act as a role model for Novartis values and behaviours. Qualifications: Education: Minimum: Bachelor's/Master’s in Life Sciences or Data Science (e.g., Analytical/Organic Chemistry, Pharmacy, Pharmaceutical Development, IT). Desirable: Ph.D. or advanced degree in a relevant discipline. Familiarity with digital tools such as eLN, GLIMS, SAP is preferred. Experience: 5–7 years in a relevant role within a GMP environment. Strong scientific and technical writing skills. Solid understanding of quality and regulatory standards in pharmaceutical development. Proven experience with data governance, master data, and IT system integration. Languages: Fluent in English (spoken and written). Knowledge of local/site language is advantageous.
Looking for a qualified and experienced Mechanical Engineer to support and manage Quality Management System (QMS) activities within the Engineering (EN) Department. The ideal candidate will have hands-on experience in engineering QMS processes and be proficient in AutoCAD for editing engineering-related drawings and documents. Key Responsibilities: Manage and maintain QMS activities specific to the Engineering (EN) Department Ensure compliance with ISO and internal QMS standards and procedures Prepare, review, and update QMS documentation including SOPs, work instructions, and quality records Coordinate and support internal and external audits Identify gaps and support continuous improvement initiatives within QMS processes Collaborate with cross-functional teams to resolve QMS-related issues Edit and revise engineering drawings using AutoCAD as per project or audit requirements Maintain documentation control systems and ensure accuracy and traceability Required Skills & Qualifications: B.Tech in Mechanical Engineering 3 to 5 years of relevant experience in QMS within an engineering or manufacturing environment Strong knowledge of Quality Management Systems, preferably ISO 9001 standards Proficiency in AutoCAD for editing and updating engineering drawings Good understanding of engineering documentation practices Attention to detail and good organizational skills Strong communication and coordination abilities
Job description Looking for a qualified and experienced Mechanical Engineer to support and manage Quality Management System (QMS) activities within the Engineering (EN) Department. The ideal candidate will have hands-on experience in engineering QMS processes and be proficient in AutoCAD for editing engineering-related drawings and documents. Key Responsibilities: Manage and maintain QMS activities specific to the Engineering (EN) Department Ensure compliance with ISO and internal QMS standards and procedures Prepare, review, and update QMS documentation including SOPs, work instructions, and quality records Coordinate and support internal and external audits Identify gaps and support continuous improvement initiatives within QMS processes Collaborate with cross-functional teams to resolve QMS-related issues Edit and revise engineering drawings using AutoCAD as per project or audit requirements Maintain documentation control systems and ensure accuracy and traceability Required Skills & Qualifications: B.Tech in Mechanical Engineering 3 to 5 years of relevant experience in QMS within an engineering or manufacturing environment Strong knowledge of Quality Management Systems, preferably ISO 9001 standards Proficiency in AutoCAD for editing and updating engineering drawings Good understanding of engineering documentation practices Attention to detail and good organizational skills Strong communication and coordination abilities
As a Trade Compliance Manager, you will be responsible for conducting denied party screening and compliance checks aligned with embargoes and sanctions. You will manage customs classification and country-of-origin determinations while preparing and maintaining import/export documentation, including licenses and shipment agreements, in adherence with relevant laws and company SOPs. Additionally, you will be coordinating customs clearances and logistics operations with internal teams and external partners. Monitoring and reporting on trade compliance KPIs, assisting with audits and regulatory reviews, and providing advisory support to business units are also key aspects of your role. Furthermore, you will deliver training on customs classification and compliance best practices and manage export control processes, including license applications and controlled-goods oversight. To qualify for this position, you should hold a Bachelor's degree in Commerce, International Trade, Logistics, or a related field and possess approximately 4 years of experience in trade compliance within the pharmaceutical or healthcare sector. Knowledge of customs regulations, import/export licensing, and trade compliance frameworks is essential. Proficiency in MS Office and ideally ERP tools such as SAP, along with strong analytical, communication, and interpersonal skills, will be beneficial for this role. Preferred attributes include experience with KPI reporting and compliance dashboards, awareness of global trade regulations, sanctions, and regulatory changes, and the ability to train and guide cross-functional teams in trade-related processes.,
The Data Quality Expert (DQE) is accountable for creating, maintaining, and optimizing dynamic master and reference data across global Analytics functions within TRD. This role ensures the accuracy, quality, and lifecycle management of data in digital systems, supporting business operations, governance, and decision-making. Key Responsibilities: Create and maintain global dynamic master and reference data. Support Line Units in transcription/setup of records in IT systems (e.g., LIMS, stability protocols). Coordinate with stakeholders for initiating/updating master data. Support global project teams and line functions on data object requests/changes. Collaborate with governance boards to maintain compliance and standards. Ensure timely updates of global and local master data across all TRD sites. Enhance end-user satisfaction through continuous support and training. Guide and educate users in best practices and key application usage. Optimize system performance and ensure robust IT system integrations. Provide coaching, mentoring, and technical expertise to team members. Promote a learning organization culture and share best practices. Monitor data quality regularly to ensure fitness for use and rule compliance. Produce Data Quality Dashboards as per defined business metrics. Analyse and act on data cleansing/enrichment requests from stakeholders. Enhance the Data Quality strategy, framework, and metrics. Design and implement cleansing and linking strategies. Develop and manage plans for data quality corrections. Work with Data Stewards, Process Owners, and Solution Designers for governance. Execute periodic DQ assessments, KPI tracking, gap analysis, and improvements. Act as a role model for Novartis values and behaviours. Qualifications: Education: Minimum: Bachelor's/Master’s in Life Sciences or Data Science (e.g., Analytical/Organic Chemistry, Pharmacy, Pharmaceutical Development, IT). Desirable: Ph.D. or advanced degree in a relevant discipline. Familiarity with digital tools such as eLN, GLIMS, SAP is preferred. Experience: 5–7 years in a relevant role within a GMP environment. Strong scientific and technical writing skills. Solid understanding of quality and regulatory standards in pharmaceutical development. Proven experience with data governance, master data, and IT system integration. Languages: Fluent in English (spoken and written). Knowledge of local/site language is advantageous.
The Data Quality Expert (DQE) is accountable for creating, maintaining, and optimizing dynamic master and reference data across global Analytics functions within TRD. This role ensures the accuracy, quality, and lifecycle management of data in digital systems, supporting business operations, governance, and decision-making. Key Responsibilities: Create and maintain global dynamic master and reference data. Support Line Units in transcription/setup of records in IT systems (e.g., LIMS, stability protocols). Coordinate with stakeholders for initiating/updating master data. Support global project teams and line functions on data object requests/changes. Collaborate with governance boards to maintain compliance and standards. Ensure timely updates of global and local master data across all TRD sites. Enhance end-user satisfaction through continuous support and training. Guide and educate users in best practices and key application usage. Optimize system performance and ensure robust IT system integrations. Provide coaching, mentoring, and technical expertise to team members. Promote a learning organization culture and share best practices. Monitor data quality regularly to ensure fitness for use and rule compliance. Produce Data Quality Dashboards as per defined business metrics. Analyse and act on data cleansing/enrichment requests from stakeholders. Enhance the Data Quality strategy, framework, and metrics. Design and implement cleansing and linking strategies. Develop and manage plans for data quality corrections. Work with Data Stewards, Process Owners, and Solution Designers for governance. Execute periodic DQ assessments, KPI tracking, gap analysis, and improvements. Act as a role model for Novartis values and behaviours. Qualifications: Education: Minimum: Bachelor's/Master’s in Life Sciences or Data Science (e.g., Analytical/Organic Chemistry, Pharmacy, Pharmaceutical Development, IT). Desirable: Ph.D. or advanced degree in a relevant discipline. Familiarity with digital tools such as eLN, GLIMS, SAP is preferred. Experience: 5–7 years in a relevant role within a GMP environment. Strong scientific and technical writing skills. Solid understanding of quality and regulatory standards in pharmaceutical development. Proven experience with data governance, master data, and IT system integration. Languages: Fluent in English (spoken and written). Knowledge of local/site language is advantageous.
The key responsibilities of the role include creating and tracking purchase orders (POs) for third-party manufacturers (CMOs) of G-PHAD, coordinating with project teams to ensure data accuracy in SAP, supporting process improvements and compliance with procurement systems like SAP S4 HANA and ARIBA, handling PO reconciliation and deviations management, defining and implementing the process for E2E Subcontracting for TRD NCE PHAD external manufacturing, ensuring correctness of SAP vendor and customer master data, coordinating with PHAD Global Project Team/EPSM/SPP and SAP business lead to improve processes, managing external purchase order (PO) requests via the TRD PO SharePoint platform, maintaining a robust tracking mechanism for PO requests, coordinating with project teams for service-related or external batch manufacturing activities, verifying all PO line items and components in SAP, ensuring accurate consumption posting in SAP based on the CMO consumption sheet, creating subcontracting, direct, and indirect PRs and POs in SAP, supporting internal and external audits and inspections, contributing to the creation, revision, and maintenance of Standard Operating Procedures (SOPs), executing SAP-related tasks to ensure accurate and complete data availability for downstream materials planning and supply processes, communicating effectively with project teams, adhering strictly to established procedures for all SAP and supply-related activities, and performing any additional supply-related tasks as assigned to the team. The key performance indicators for the role include timely, accurate, and reliable completion of assigned responsibilities within defined budgetary constraints, delivery of solutions that meet high standards of customer satisfaction while ensuring full compliance with applicable regulations, and consistent alignment with Novartis standards, particularly in the areas of ethics, health, safety, and environment. The ideal background for the role includes a bachelor's degree in science, Commerce, Engineering, Business Administration, or a related field, with desirable expertise in IT systems such as SAP S/4HANA and ARIBA, experience as an SAP Key User in modules like MM, FI, PP, WM, fluency in English, both written and spoken, 3 to 8 years of relevant experience in a business support role within supply chain, SAP domains, or pharmaceutical/manufacturing organizations, over 3 years of hands-on experience in technical domains such as supply chain operations and SAP applications, a proven track record in project and implementation management with strong organizational and planning capabilities, willingness to learn and adapt, strong troubleshooting and support engagement skills, proficiency in action plan tracking and issue resolution, and effective team collaboration and communication.,
The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, allocate resources, and manage budgets. Monitor project progress and ensure milestones are met within the set constraints. Technology Transfer Execution: Facilitate the transfer of manufacturing / analytical processes between transferring sites. Collaborate with cross-functional teams (R&D, QC, Quality, Regulatory, and Manufacturing) to ensure a smooth transition. Provide technical support during process scale-up, validation, and commercial launch. Process Documentation & Compliance: Prepare and review technology transfer documents, including Master Batch Records, Process Validation Protocols, and Reports. Ensure compliance with cGMP, regulatory guidelines, and company SOPs. Support the preparation of regulatory submissions related to process validation and manufacturing changes. Troubleshooting & Continuous Improvement: Identify and resolve technical challenges during process transfer. Analyse data and propose improvements to enhance efficiency, yield, and quality. Work with production teams to implement process optimizations. Risk Management: Identify potential risks and develop mitigation strategies. Address project roadblocks proactively to minimize delays or budget overruns. Process Improvement and Innovation: Evaluate and implement process optimization opportunities. Lead initiatives to improve manufacturing efficiency and product quality. Collaboration & Stakeholder Management: Liaise with external partners, vendors, and regulatory bodies as needed. Participate in cross-functional meetings and ensure project timelines are met. Qualifications & Experience: Education: B.Pharm / M.Pharm (Pharmaceutical Sciences) Experience: 3-6 years in technology transfer, process development, or manufacturing in a regulated pharmaceutical environment. Knowledge: Strong understanding of cGMP, ICH guidelines, and regulatory expectations. Experience with process validation, scale-up, and troubleshooting. Familiarity with solid oral dosage forms. Key Skills: Strong analytical and problem-solving abilities. Excellent documentation and technical writing skills. Effective communication and cross-functional collaboration. Ability to handle multiple projects with attention to detail.,
Roles & Responsibilities Perform activities as per safety precautions, cGMP, and adhere to Quality Policy. Perform and document activities as per good documentation practices (GDP) with data integrity. Verify laboratory ambience for a clean and safe workplace. Verify analytical instrument calibration. Ensure continuous training and development of team members. Prepare, review, and maintain standard operating procedures. Prepare and review specifications and standard testing procedures for products. Review test data sheets. Review audit compliance reports and ensure effective implementation. Review events, incidents, OOT, and OOS. Review controlled documentation systems in QC department. Assist in writing, revising, and verifying quality standards, procedures, and forms. Record, evaluate, and report quality data. Execute and monitor analytical QA-related activities. Prepare and conduct QA-related training. Review analytical deviations, PNCs, OOS, and change controls. Review investigations related to product complaints and OOS, and implement preventive actions. Review certificates of analysis. Review aberrant results. Review trend analysis reports. Review stability protocols. Review GMP documents like SOPs, protocols, schedules, specifications, STPs, and GTPs. Review vendor qualification documents related to QC laboratory. Review validations and verifications to be performed. Review qualification documents. Review activities related to process validation, method development/transfer, hold time studies, and validation reports. Record temperature in control/sample rooms. Conduct and support internal audits, self-inspections, and contract analytical site audits. Conduct vendor audits. Verify reference and retention samples. Perform sampling and release of raw/packing materials. Verify receipt and segregation of raw/packing materials. Supervise sampling, testing, and dispensing of raw/packing materials. Perform water sampling and analysis as per schedule. Control raw data (collecting, storing, issuing, retrieving, destroying documents). Perform documentation control. Arrange and coordinate documentation cell activities. Review training programs/documents like SOPs, STPs, specifications, and protocols. Issue and retrieve controlled documents (SOPs, formats, analytical data, protocols, etc.). Execute other jobs assigned by HOD outside defined responsibilities. Monitor transportation of samples to external QC laboratories as per transport validation.
We are seeking an experienced Instrumentation Engineer specializing in pharmaceutical process and packing instrumentation. The candidate will be responsible for managing calibration, maintenance, and troubleshooting of field instruments and automation systems including SCADA, PLC, and DCS. The role will also involve compliance with GMP standards, equipment qualification, and supporting regulatory inspections. Key Responsibilities Operate and troubleshoot SCADA- and PLC-based systems (Allen Bradley, Siemens, Schneider, Polmon, etc.). Maintain and calibrate field instruments (Temperature, Pressure, Flow, Conductivity, pH, Level Transmitters, etc.). Execute breakdown maintenance and preventive maintenance activities for process and packing equipment. Conduct instrumentation and automation for pharma process utilities: reactors, tray dryers, centrifuges, lyophilizes, solvent systems, etc. Develop and review SOPs and calibration schedules in accordance with GMP and regulatory guidelines. Manage Quality Management System (QMS) activities including deviation handling, change control, and documentation. Perform installation, commissioning, and validation (IQ/OQ/PQ) of instrumentation and control systems. Support regulatory audits and ensure documentation aligns with 21 CFR Part 11 and other compliance standards. Lead projects involving utility automation systems like Single Fluid Heat Transfer Systems (SFHTS), clean room monitoring, and nitrogen/air compressor systems.