Summary Participate as a Trainee Engineer in NOCC Engineering team at Novartis Hyderabad. Responsible for the operational support to business functions in managing contractors and external services as well represent an interface between internal community and external partners. To be acted as a single point of contact for all in accordance with legislation, internal regulations, good practices and business objectives via NOCC Engineering project team. Additionally, this role is crucial to have some knowledge to perform conceptual, basic and detail engineering design for various facilities like Pharma, Biotech & Chemical operation facility, Aseptic facility, Solids and Packaging facility and in compliance with local as well as international regulations. About the Role Major accountabilities: In depth knowledge of Engineering subjects, ability to use systems and tools (e.g., MS office, Excel, etc.) for documentation and reporting. Participate in the review meetings with users, cross functional team and external vendors. Also contribute to review process improvements and provide the innovative solutions to process issues. Contribute in the preparation of project assignments, timely compilation of tender documents, technical bid analysis, preparation of technical solutions within the legal framework, internal quality and HSE requirements. Perform other tasks as assigned by the supervisor, and tasks based on a specific appointment. Creating purchase orders and ordering equipment in SAP/ESHOP. Care and maintenance of electronic databases (SharePoint). Responsibility for ensuring the consistency and quality of procedures and documentation. SPOC to the external service provider regarding operational processes related to external employees (announcements of new employees, assuming new roles, replacements, etc.). Providing support to the Training & Learning organization in defining the training that will help the external associates to obtain their qualifications. Management and review of training roles for all external colleagues in the field of work and regular monitoring of the education of external colleagues and ensuring the consistency of training. Ensuring that updated production documents are sent to relevant external colleagues for the purpose of education (reading and understanding) and transferring knowledge to colleagues and, if necessary, conducting training (OJT) for relevant colleagues. Support for ensuring the implementation of external services according to defined KPIs. Collaborate with internal users and relevant line functions to bring the common understanding on the scope of the work with an emphasis on GMP, Safety and cost optimization. Work in conjunction with the relevant line functions to complete the project deliverables in time and in full. Work Experience: 0-1 yr in relevant role Knowledge of Microsoft Office Knowledge of SAP recommended Financial knowledge Good communication (English) both spoken and written

1.To see the packing line plan and work accordingly and Checking of BOM against SAP BOM, SAP related work and verify the quantity dispensed accordingly. 2.Training to be given to the workmen & Operator in the concerned area as per the cGMP guidelines and maintaining Training record, printing activity and barcoding activity. 3.All documentation work like Deviation observed during packing activity, handling of Change control and submission after completing all the formality, Market complaints , New Machine/Equipment Qualification. 4.To Co-ordination with QA and QC dept. regarding the line clearance, samples collection and its release for further process.

Vision To acquire and maintain global leadership position in chosen areas of businesses To continuously create new opportunities for growth in our strategic businesses To be among the top 10 most admired companies to work for To continuously achieve a return on invested capital of at least 10 points higher than the cost of capital. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC 22000, NABL . Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling & Analysis. Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) Qualification & Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional & Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument ",

Summary Novartis operates multiple manufacturing sites globally to produce cutting-edge Cell and Gene Therapy products and Biologics (Large Molecules). As a Discoverant Specialist, you will play a pivotal role in supporting the Discoverant System Business Owner within Novartis Technical Operations (NTO). Discoverant is a validated IT solution utilized across NTO for automated manufacturing data aggregation, advanced analysis, and comprehensive reporting. In this role, you will act as the global Discoverant Super User, collaborating with IT teams, manufacturing sites, and the Discoverant Global Business Owner. Your responsibilities will include ensuring optimal system setup, seamless change implementations, and ongoing maintenance of the Discoverant platform across the Novartis network. About the Role Major Accountabilities Serve as the primary business-side representative for the implementation, lifecycle management, and ongoing evolution of the Discoverant system, ensuring effective collaboration with local users, IT, and system vendors under the guidance of the business owner. Coordinate Discoverant interfaces with integrated IT systems, including ERP (SAP), MES, LIMS, Data Historians, and patient scheduling tools (e.g., CellChain), leveraging cloud-based manufacturing and quality data storage solutions. Facilitate onboarding for new internal and external users, conduct training sessions, and promote knowledge sharing among end users. Develop and optimize data analytics components, including dashboards, control charts, automated reports, and advanced analytics, utilizing best practices and tools like Pipeline Pilot. Drive change control processes for the Discoverant system, integrating new parameters, products, and architectural updates, including respective interface modifications, while supporting local and global risk and impact assessments. Support data integration from new systems and parameters into Discoverant to meet manufacturing data trending and analysis needs, aligning data flow from source systems to Discoverant and advanced analytics platforms. Assess data quality, implement corrective actions, and propose improvements to ensure data accuracy and reliability. Manage manufacturing data provision for internal stakeholders outside the manufacturing group. Address and resolve Discoverant-related deviations, quality events, and associated actions. Act as a liaison between local Discoverant users, IT teams, and system vendors to ensure smooth operations and system enhancements. Author and maintain Discoverant-specific Standard Operating Procedures (SOPs) and Working Procedures (WPs). Key Performance Indicators (Indicate how performance for this role will be measured) Quality / Accuracy / Right First Time Timeliness Deviations / Escalations Job Dimensions ( Number of staff reporting) Indicate key facts and figures) Direct: 0 Financial responsibility (Budget, Cost, Sales, etc.) Operational Budget: na Impact on the Organization Contribute to increased level of automation in manufacturing Significant impact on ensuring competitive advantage in quality and costs by improving the relevant data and digital technology standards Contribute to Site Manufacturing financial / business goals. Minimize process-related rejected batches and write- offs. Maximize process robustness Skills: Good Documentation Practice Effective communicator Strong cross functional collaboration Adaptability to Embrace Change Effective stakeholder engagement Manufacturing Process Knowledge Of GMP (Good Manufacturing Practices) Change Control Deviation management Corrective and preventive action (CAPA) Continual Improvement Process General HSE Knowledge Manufacturing (Production) Ideal Background / Requirements for the role Education (minimum): University degree in Engineering, Computer Sciences, Technology (Chemical/Biology) or similar field Languages Fluent in English and additional languages desirable (German, French, other) Relevant Experiences 5 years of practical experience in the pharmaceutical industry, with expertise in manufacturing IT systems. Hands-on experience with Biovias Discoverant and Pipeline Pilot tools. Knowledge of integrated IT systems such as ERP (SAP), MES, LIMS, OSI-PI, SQL, Oracle/MS SQL databases, and cloud-based data storage solutions. Comprehensive understanding of pharmaceutical cGMP, Computerized System Validation (CSV), and regulatory requirements. Familiarity with statistical tools and programming languages such as Minitab, JMP, Python, and R is a plus. Knowledge of data handling applied statistics, and Six Sigma methodologies. Proven ability to collaborate effectively with team members, site experts, and organizational leaders, with a capacity to influence without direct authority. Solid project management and presentation skills, with the ability to lead cross-functional initiatives. Excellent communication and interpersonal skills to foster collaboration and drive results.

The Manager ProductDevelopment is a senior position in the Foods Business mandated to design,develop and supervise the implementation of the Categories Product developmentstrategy. Principal Accountabilities Actively collaborate with cross-functional teams to drive PD projects from concept to commercialization with focused, agile and speedy execution. Drive expansion into new range of offerings as per business plan to develop competitively superior product portfolio. Focus on upgrading and updating product quality parameters and systems for existing products ensuring that consumer feedback feeds into the quality and manufacturing systems so that consistent quality is maintained in the market. Develop scientific building blocks for future innovation and portfolio building Ensure scientific backing for meaningful product claims and applying for IP in relevant cases. Responsible for onboarding vendors, quality system/documentation to ensure consistent quality in seasoning and regulatory compliance for all the product development & manufacturing Develop team members to enhance their skill sets and technical capabilities Requirements Expertise in Food sciences, Processing technologies and must have contributed in developing and launching the products (from pilot to commercial scale) in previous organizations. Experience of leading a team, Technical Knowledge and experience of: Product Formulation, chemical composition, ingredient properties and functions, techniques of processing/manufacturing & storage Food analysis instrumentation & procedures Food related statutory compliances Microbiology, food safety, food chemistry, food preservation and shelf-life study Manufacturing and quality systems such as HACCP, GMP, ISO, TPM, Six-sigma and Lean Design of experiments, Statistical analysis and interpretation of data Claim substantiation and IP Product costing and contributions

" Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com The Position Organization - Jubilant Pharmova Limited Designation - Manager- Procurement Purchase Location - Nanjangud, Mysore Key Responsibilities: Shall be responsible for the following activities: Procurement of raw materials, Packing material, solvents & Acid tankers. Identification of new sources to mitigate single source dependency Coordinating with vendors and negotiating the right price, quality and timelines. Ensure the payments to all vendors and service providers. Coordinating with logistics and service providers. Ensure GMP and regulatory compliance. Meet the RM Delivery schedule and ensure sequence production in terms of RM Supply. Monitoring inventory and schedule deliveries. Sale of non-moving materials Yearly Agreement for transporter contractors External manufacturing actives Service bills processing Renewal of Certifications {UN Drums} Vendor rating as per SOP Verification and scrutiny of vendor quality documents, forwarding to QA and monitoring the qualification process with IP, QA, QC, R&D and RA. Alternate vendor development Vendor re qualifications as per SOP Review and approval of QMS documents Handling of CDMO projects Requirement: Qualification: BSc/MSc - Chemical Engineering Purchase experience: 10+ years of experience in Raw Meterial procurement from Pharma API or Chemical industry Experience in procurement of KSM, Intermediate, Chemicals, Solvents and Catalogue chemicals Handled procurement of: 400 Cr per annum. ",

Ensuring implementation and monitoring of the Quality systems at Sanofi s External manufacturing sites as per cGMP and Sanofi Global quality document requirements in order to ensure the quality of products delivered to market. Our Mission: We Lead and manage the Quality strategy within the External Manufacturing site s network to ensure that drug products manufacturing and distribution activities are in compliance with the Global Quality standards and applicable regulatory requirements. Main responsibilities: Digital Transformation: - Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc as appropriate. - Providing feedback on the roadblocks and difficulties met related to CoP area supported. - Providing return on experience on inspection assessing the CoP area supported. - Proposing evolution for simplification and harmonization of the process and tool. - Sharing successes and best practices with other sites. - Contributing to the objectives set via the CoP roadmap. - Cascade all relevant information to all impacted stakeholders and ensure that the application of the process is well deployed and implemented at entity level when needed to ensure adherence to the standardized approach defined during the CoP -Act as primary focal point for digital initiatives coming from global -Promote a performance & data driven mindset, leveraging the power of digital tools -Ensure the effective use of Digital to transform Quality & Regulatory department operations according to the EM&S digital roadmap to deliver impact. -Use of digital tool One Quad for Quality KPI reporting. -Act as SME for Global Digital Transformation Project Management: Collaborate with the team of projects managers in charge of activities related to technology transfers, new product launches, new API source qualification and validation activities (process, analytical) requiring transversal coordination Ensure efficient partnership with other functions involved in project management, especially Technical Operations and operational support functions Ensure projects are delivered on time, at expected cost and right quality level Ensure that changes during projects are evaluated and their impact on planning, costs Ensure that risks identified during project are escalated according to procedure in force Process Enhancement: Lead and coordinate deployment of SMS tools within Quality & Regulatory Department: SMS training, VSM/VSD, DGBI, +QDCI, GPS3 Deploy and maintain global quality programs (eg Quality Maturity Index, Data integrity) Collect, report and analyse KPIs of Quality & Regulatory department (eg +QDCI, Global Quality KPIs) and propose improvements. CMO Performance Monitoring: Ensure quality contracts are in place and updated with CMOs, suppliers, third parties and internal stakeholders Track and report quality performance of all CMOs & Suppliers within its perimeter. Oversight the performance of the Complaints, audit PQR and SQR Planner Execution on time. Coordinate the preparation of Business Review meetings with CMOs for all that is related to Quality & Compliance aspects Ensure system is in place to monitor and maintain CMO, suppliers and third parties qualification Ensure and Coordinate audits planning and execution (CMO, suppliers, Third parties, self-inspections) Quality System Management: Ensure and escalate the adverse trending to Operational team on regular basis for meeting the Quality KPI targets. Conduct regular training on Digital tools and workflows. Ensure the right QMS workflows are followed as per global procedures. Supervise and coordinate GMP training programs for EM&S GenMed APAC Hub Maintain EM&S GenMed APAC quality documentation using Sanofi CMS tool, ensuring implementation of Global Sanofi documentation Ensure implementation of global Quality Management System tools (change control, Third party qualification, Events and CAPA, etc Audits & Risk Management: Act as primary focal point for, HA Audits and internal audits (Self Inspection) Coordinate Risk reviews and annual Quality Review for the EM&S GenMed India Ensure and Perform the Access review of all Digital tools for Users in entity. Computerized System: Maintain the inventory of Computerized system as per global procedures. Ensure and execute the qualification of Local Computerized system. Coordinate with global for qualification records for Global computerized system. Act as tester in local/global computerized system as and when required. About you: Experience : (>12 years of experience in Quality Assurance) Soft skills : Team handling, Stakeholders management, Effective communication with external partners -CMOs, and ability to work independently. Technical skills : Quality Assurance, Quality Control, Effective Analyzing skills, Strong cross-functional collaboration, teamwork, and stakeholder management. Handling of different pharmaceutical dosage forms Managerial courage - ability to make difficult decision and implement successfully Education : (B.Pharm/ M.Pharm/ MSc/PHD in lifesciences) Languages : English, Hindi

" Kindly refer www.jubilantpharma.com for more information about organization. Position Assistant Manager - QC Business Unit / Function Department Quality Control Location Bharuch SEZ Reports to QC Head Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory & Pharmacopeia requirement for lab compliance. Review of hybrid & electronic data for IPQC & FG analysis. Analytical method validation, OOS & OOT. Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities. Training to subordinate & employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification & Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies (Technical, Functional & Behavioral) Responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data & hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Site Quality Head CQA & RA Head Unit HR Head ",

Quality Control (QC) Officer ensures products meet quality standards and regulatory requirements by performing tests, Analyzing results, and maintaining records, ensuring safe and effective medications. Must Experience in FDA Approved Company.

Responsible for Supplier Quality Management activities - Supplier onboarding, Supplier routine monitoring and Supplier Exits from Quality & Compliance perspective. Job Description Supplier Quality Management: Drafting of Annual Monitoring and Certification report for incoming materials Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with Suppliers/Service providers Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of change record for the applicable SCN Drafting and Evaluation of Supplier s incoming materials Specification Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers Management of Supplier/ Material qualification and supplier related documentations Preparation of regulatory statement for materials and finished products Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rd PAP Management in TPRM (Third Party Risk Management) tool Co-ordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables Evaluation of Change control tasks related to supplier quality management Audit preparation support and CAPA Management End to end deliverables for supplier quality management activities as per the delegated task from the business partner. Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

You are accountable for the teams performance, compliance, and audit readiness, managing product return and replacement processes, and partnering with global colleagues to resolve issues. You will ensure the team is trained and proficient, support the development of training programs, and promote quality risk management. Leading the surveillance team, you will generate complaint metrics and monitor KPIs to improve processes. You will also support Product Surety/Corporate Security and Serialization activities, manage employee-related activities, and foster a collaborative and empowered team environment. Key Responsibilities As Hyderabad Product Quality Complaints (PQC) Team lead, you are accountable for the delivery performance and quality of service provided by the HYD PQC team. Reporting to the HYD Global Quality Lead, you will work closely with the Global Process Owner for Product Quality Complaints to deliver compliant, accurate, timely and efficient services for the management of Product Quality Complaints and associated data, systems and processes for BMS products. Leading the Hyderabad Product Quality Complaints (PQCs) team members to deliver robust and timely processing of Product Quality Complaints (PQCs) to meet enterprise and global regulatory requirements Leading the Hyderabad PQC surveillance team to collect, manage and analyze PQC data, highlighting trends, signals and risks and focus areas to PQC Management and Quality Councils supporting effective decision making to protect the organization and our patients and to optimise PQC performance Leading the Hyderabad PQC digital team to design, deliver and maintain digital solutions to optimize PQC processes, deliver efficiencies in PQC process performance and optimize system interfaces Communicates continuously and effectively with management (Global Quality Lead, Hyderabad, Senior/ Director Product Quality Complaints, Site Quality & Compliance Leadership as appropriate) and key PQC stakeholders on PQC related matters Accountable for HYD PQC team delivery of performance and compliance requirements, in alignment with HYD Global Quality Lead, and Senior Director Product Quality Complaints Accountable through your HYD team for daily case processing of incoming PQCs while adhering to triage timelines and ensuring compliance to global Health Authority reporting (eg Field Alert Reports, Medical Device Reports, etc) Accountable through your HYD team for delivering comprehensive, timely and compliant PQC reports and records for closure to designated Quality approvers across the network Accountable for the continuous audit-ready state of the HYD team Manage the product return and product replacement processes required for PQC investigation Partner with global PQC US/EU colleagues and/or market Quality colleagues and/or network sites and/or third parties to ensure timely resolution to PQC sample return and/or product replacement issues Partner with PQC Management, and key stakeholders (intake teams, Medical Information, Safety, Third Parties, PQC Local Process Owners and Investigation sites to optimize the intake & processing of Product Quality Complaints Escalate system performance issues to PQC Systems Support for expedited resolution Accountable through the HYD team for the optimum performance of digital tools (BOTs, dashboards, Sharepoints, flash reports etc) Develop trusting, open and collaborative partnerships while ensuring stakeholders have a clear understanding of BMSs PQC procedural requirements Support the development and implementation of PQC training programs including new product launch trainings Ensure the local HYD PQC team are adequately trained and proficient to complete required PQC-related actions, in line with BMS policies, procedures and regulatory expectations Provide experienced based training and mentoring to PQC HYD team and external personnel supporting PQC processing to ensure compliance with regulations Assist in the establishment of quality risk management for complaint handling and promote the understanding of risk management for product quality complaints Leading the HYD surveillance team, accountable for complaint metrics generation as well as monitoring of Key Performance Indicators (KPls) to facilitate improvements for end-to-end complaint process Support Product Surety/Corporate Security and Serialization activities as necessary Grows, develops, engages and empowers team Manage employee related activities for the department (hires, trains, appraises, mentors, motivates, disciplines) The roles, responsibilities and duties prescribed in this job description are descriptive but may not be all inclusive. Qualifications & Experience Bachelor of Science in Life Sciences (Chemistry, Biology) or Health Sciences. Post-graduate qualification preferred. A minimum of 7 years of pharmaceutical industry GMP experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements. Experience in a senior role with product quality complaints involving global teams and globally distributed products is required. A minimum of 3 years experience in a people management role is required. Prior employment on a pharmaceutical manufacturing site in a Quality or operations role is an advantage. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking Excellent communication with management, peers, and other functional areas Subject matter expertise in global regulatory requirements and expectations for management of PQCs is required Excellent understanding of product formulation* & presentation* types, defect categories applicable to each, and the inherent risk that defect types pose to patient safety *(Solid Oral Dose, Device/Combination, Topical, Liquid / Suspension / Powder / Freeze-Dried Parenteral etc) Ability to apply critical thinking in a high-volume, fast-paced environment, in the knowledge that decisions taken support patient safety Strong people management expertise and ability to focus on execution of strategic decisions while balance conflicting priorities Ability to effectively lead teams to thrive in a fast-paced, highly regulated environment Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives Demonstrated ability to make and act on decisions while balancing speed, quality and risk Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments A continuous improvement mindset Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments Customer and partner focus, including the ability to listen and incorporate feedback from key stakeholders Strong analytical skills and ability to deliver meaningful messaging from data analysis Financial acumen to meet budget for PQC processing Strong working knowledge in software and applications relevant to the role (eQMS eg VEEVA Infinity, ERP eg SAP, artwork eg BAMS, regulatory eg Verity, MS Office - Word, Excel, Powerpoint, Sharepoint) Commitment to Quality

Responsible for the operational support to business functions in managing contractors and external services as well represent an interface between internal community and external partners. To be acted as a single point of contact for all in accordance with legislation, internal regulations, good practices and business objectives via NOCC Engineering project team. Additionally, this role is crucial to have some knowledge to perform conceptual, basic and detail engineering design for various facilities like Pharma, Biotech & Chemical operation facility, Aseptic facility, Solids and Packaging facility and in compliance with local as well as international regulations. Job Description Major accountabilities: In depth knowledge of Engineering subjects, ability to use systems and tools (e.g., MS office, Excel, etc.) for documentation and reporting. Participate in the review meetings with users, cross functional team and external vendors. Also contribute to review process improvements and provide the innovative solutions to process issues. Contribute in the preparation of project assignments, timely compilation of tender documents, technical bid analysis, preparation of technical solutions within the legal framework, internal quality and HSE requirements. Perform other tasks as assigned by the supervisor, and tasks based on a specific appointment. Creating purchase orders and ordering equipment in SAP/ESHOP. Care and maintenance of electronic databases (SharePoint). Responsibility for ensuring the consistency and quality of procedures and documentation. SPOC to the external service provider regarding operational processes related to external employees (announcements of new employees, assuming new roles, replacements, etc.). Providing support to the Training & Learning organization in defining the training that will help the external associates to obtain their qualifications. Management and review of training roles for all external colleagues in the field of work and regular monitoring of the education of external colleagues and ensuring the consistency of training. Ensuring that updated production documents are sent to relevant external colleagues for the purpose of education (reading and understanding) and transferring knowledge to colleagues and, if necessary, conducting training (OJT) for relevant colleagues. Support for ensuring the implementation of external services according to defined KPIs. Collaborate with internal users and relevant line functions to bring the common understanding on the scope of the work with an emphasis on GMP, Safety and cost optimization. Work in conjunction with the relevant line functions to complete the project deliverables in time and in full. Work Experience: 0-1 yr in relevant role Knowledge of Microsoft Office Knowledge of SAP recommended Financial knowledge Good communication (English) both spoken and written Skills Desired Architectural Engineering, Business Networking, Cooperation, Efficiency, Employee Welfare, General Hse Knowledge , Heat Transfer, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Job Description, Knowledge Of Gmp, Manufacturing Production, Mathematical Optimization, Microsoft Word, Outside Sales, Physics, Qualification, Software Troubleshooting, Team Work, Test Equipment, Total Productive Maintenance

Role & responsibilities : CORPORATE QUAKLITY ASSURANCE 1. Specification Preparation & Documentation Develop and maintain specifications for raw materials (APIs, excipients) and packing materials. Ensure specifications comply with pharmacopeial standards and in-house quality standards. Review and update specifications based on regulatory updates, stability studies, and supplier changes. Coordinate with purchase, packaging development, QC, and regulatory teams for finalizing specifications. 2. Raw Material (RM) Specification Management Maintain records of Material Safety Data Sheets (MSDS) and Certificates of Analysis (COA) from suppliers. 3. Packing Material (PM) Specification Management Develop specifications for primary, secondary, and tertiary packaging materials. Ensure packing materials comply with stability, compatibility, and regulatory requirements. Conduct compatibility studies to assess interaction with drug formulations. Define parameters like GSM, burst strength, WVTR, dimensions, artwork compliance. 4. Regulatory & Compliance Assurance Ensure regulatory compliance with global standards (USFDA, WHO-GMP) Assist in audit preparation and responses related to material specifications. Ensure proper documentation and version control of Master Specification Files. 5. Vendor & Cross-functional Coordination Collaborate with vendors for RM & PM specification approvals. Work with Quality Control (QC), Quality Assurance, and Procurement to resolve material specification issues. Participate in vendor qualification, site audits, and material evaluation. 6. Acting as SPOC Between Factory & Corporate Serve as the primary liaison between the corporate QA team and the factory team regarding RM & PM specifications. Ensure smooth communication and implementation of corporate quality standards at the factory level. Address and resolve factory concerns related to RM & PM specifications in coordination with corporate QA. 7.Addressing Factory Concerns & Quality Compliance Resolve factory-level issues related to raw and packing materials by aligning corporate directives. Support factory teams in implementing quality control procedures for RM & PM. Ensure material handling, storage, and testing compliance at factory sites. Coordinate and support regulatory inspections and customer audits at manufacturing sites. Ensure timely CAPA (Corrective and Preventive Action) implementation post-audits. Maintain audit readiness across manufacturing and distribution facilities Design and approve the corporate documents to meet highest levels of quality standards. Conduct vendor audits and qualification for raw materials, packing materials, and contract manufacturers (P2P). Collaborate with the Procurement Department to ensure suppliers meet the required quality standards. Establish quality agreements with vendors and monitor compliance. specifications in coordination with corporate QA. Knowledge Required 1. 8 10years of relevant experience in Pharma industry. 2. Strong knowledge of pharmacopeia standards (IP, USP, BP, EP). 3. Expertise in specification writing and document management. 4. Knowledge of analytical techniques (HPLC, GC, UV, Titration, etc.). 5. Familiarity with ICH Q3C, Q6A, GMP, and GDP guidelines. 6. Knowledge of Specification Preparation of Raw Material / Packing Material / Finished Product 7. Knowledge of Pharmacopeia Monograph - Indian Pharmacopoeia / British Pharmacopoeia / United States Pharmacopoeia 8. Must have knowledge of General Testing Procedures related to Raw Material / Packing Material / Finished Product testing. 9. Must have proficiency in computer operating ( Specially MS Word ) 10. Able to communicate effectively with Factory Site and Purchase / RA Dept.. 11. Shall be able to communicate with Purchase Dept. related to P2P products. 12. Ensure cross-functional teams (Production, Purchase, Regulatory Affairs) are aligned with quality expectations. 13. Should be able to travel to third party site/s. 14. Should possess good verbal and written communication skills. 15. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, WHO, ISO etc. Please note: Female candidate is preferred provided she should be able to travel outstation once in week on monthly basis.

1. Amino acid validation. 2. In-Process and finished products analysis. 3. Product development product analysis. 4. Documentation. 5. Responsible for method process Share resume to hrd@stedmanpharma.com, Call 7904827192/9786920463 Perks and benefits Canteen and other welfare benefits.

Handling entire plant operations like production, QC, manpower, maintenance, electrical, housekeeping, GMP, GHP, HACCP, ISO certification, etc. people handling, costing, and budgeting Required Candidate profile Should be a good communicator, have B.tech or MSc or any other similar qualifications, and sound knowledge in plant operations. Age more than 40 + preferred.

Dear Candidate, We are pleased to invite you to a walk-in interview for the position of Production Executive Details are mentioned below. Qualifications: - B.Sc./M.Sc./ B.E - B.Tech (Chemical Engg.) - 1 to 9 years of experience. - Experience in handling critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. The interview will be held on : Venue - Alembic Vidyalay, Opp. Bhailal Amin General Hospital, Alembic- Gorwa, Vadodara, Gujarat - 390003 Please bring a copy of your resume. During the interview, we will discuss the job requirements and your qualifications, and answer any questions you may have about the company and the position. We encourage you to be prepared and dress professionally. We look forward to meeting you and discussing this opportunity further.

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Good understanding of the GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ICH Quality and other regulatory guidelines Review requirements, specifications, and technical design documents to provide timely and meaningful feedback. Experience in Validation life cycle of regulated projects GxP Awareness including Good Documentation. Practice Knowledge on Change control and Deviations, GAMP Categorization, Protocol Preparation, Vendor Evaluation. Good knowledge on pharma regulatory compliance processes and regulations Ensure all defined Process Engineering phases are reviewed, verified & defect removal is done. Take responsibility for creating the Project Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems. Performing Internal Audits as per annual inspection plan for GxP/GMP compliance and quality review. Capture the lessons and best practices in projects and suggest process improvements at the organization level. Conduct process related trainings and its tracking. Practice on Review for Requirement Specifications. (URS,FS and DS) Ensure that all sources are baseline and stored centrally in the central repository and local library of the project. Conduct baseline audits and reviews. Troubleshooting / investigating project defect database and bugs are classified. Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects. Experience in SDLC phases & Software Release strategy. Candidate should have work experience in software & Pharma industry.Role & responsibilities

Hiring for "Executive " for Leading Biotechnology company Knowledge of Protein Purification Knowledge of GMP standards, SOPs and quality management systems Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards.

Coordinate renewal processes for various certification document preparation. Quality Monitoring & audits, Vendor & customer compliance Verify CCP/OPRP processes and product label Carryout internal audit & maintain audit finding & NC closure records. Perks and benefits Medical, Canteen

1. Ensure Quality & Safety of food products 2. Monitor QCD activities 3. FSSAI, FSMS implementation & Management 4. Legal & Regulatory compliance 5. Customer complaint handling 6. R&D- New product launch 7. MIS reports Required Candidate profile * Master's degree in Food Technology, Food Science * 12-15 years of experience in food processing industry * Strong knowledge of Food safety, laws & regulations * Good communication & Leadership skill

We are seeking a highly skilled and detail-oriented Food Technologist to join our R&D team at DS Group. The ideal candidate will play a critical role in analyzing food materials, developing new products, ensuring regulatory compliance, and maintaining proper documentation in line with industry best practices. Key Responsibilities: 1. Food Material Analysis & Laboratory Practices 2. New Product Development & Nutritional Analysis 3. Regulatory Compliance & Food Safety Standards 4. Documentation & Record Keeping

Responsible for achieving sales target for the allocated region. Deep understanding of Pharma GMP testing industry and the testing requirements of Method Development and Validation, Trace analysis (Nitrosamine, Elemental, Genotoxic, Related substances) EL Testing Packaging testing. Responsible for generating leads for all Pharma GMP analytical testing. Responsible for end-to-end sales cycle. MSc., M. Pharma, MBA in Pharma, Chemistry or Analytical Chemistry.

Job Summary The Corporate Quality Manager will work closely with the relevant stakeholders to drive Process Excellence Initiatives. This role will drive continuous improvement, risk management, and customer satisfaction. Key Responsibilities Continuous Improvement Drive continuous improvement initiatives, including Lean, Six Sigma, or other methodologies to achieve efficiency improvements, customer value creation and delivery excellence Customer Satisfaction: Monitor and analyze customer feedback, ensuring effective resolution of quality-related issues. Quality Metrics and Reporting: Develop and track quality metrics, providing regular reports to senior management. Collaborate with internal stakeholders and clients to drive and influence improvement objectives. Provide support and guidance to develop and design documents including training manuals, process outlines, flowcharts, checklists, templates, and implementation procedures. Mentor and support candidates pursuing Six Sigma Yellow Belt certifications. Hands on work on project implementation, including project plan creation, governance, stakeholder management, toll gate reviews and benefit quantification Quality Management Systems: Adhere to quality management systems, including ISO 9001, ISO 27001, or other relevant standards. Requirements Education: Any Bachelor's or Masters degree Experience: Minimum 12 to 15 years of experience in the field of Process Excellence, with at least 5 years in a managerial role Certifications: Six Sigma Green Belt, Certified Lean Practioner or other relevant certifications. Data Analysis Skills: Proficiency in data analysis tools (e.g., Excel, Tableau). Nice to Have Industry Experience: Experience in US healthcare will be an added advantage (preferred Healthcare (RCM) experience, insurance collection business, F&A Order to Cash)

1.Responsible for batch record issuance. 2 Responsible for issuance of change control 3.Resposible for implementation of ISO & Quality Management System 4. Responsible for calibration & validation of Equipements & Instruments 5. Responsible for inprocess Quality Checks 6.Resposible to implement CGMP 7. Responsible to monitor product activity 8. Responsible for issuance & retrival of control document 9. Resposible for dispatch verification 10. resposible to prepare process validation proyocal & record