96 Edms Jobs - Page 4

Responsibilities Copy, scan and store documents Check for accuracy and edit files, like contracts Review and update technical documents (e. g. manuals and workflows) Distribute project-related copies to internal teams File documents in physical and digital records Create templates for future use Retrieve files as requested by employees and clients Manage the flow of documentation within the organization Maintain confidentiality around sensitive information and terms of agreement Prepare ad-hoc reports on projects as needed Requirements and skills Proven work experience as a Document Controller or similar role Familiarity with project management Hands-on experience with MS Office and MS Excel Knowledge of Electronic Document Management Systems (EDMS) Proficient typing and editing skills Data organization skills Attention to detail BSc degree in Project Management or relevant field

Preparing document status report procedure & instruction for managing Project Communicating & interacting with internal discipline, external stakeholder for Client Contractor subcontractor & Vendor Presenting Document management & imparting training

We re AtkinsR alis, a world-leading Design, Engineering and Project Management organization. Created by the integration of long-standing organizations dating back to 1911, we are a world-leading professional services and project management company dedicated to engineering a better future for our planet and its people. We create sustainable solutions that connect people, data, and technology to transform the worlds infrastructure and energy systems. We deploy global capabilities locally to our clients and deliver unique end-to-end services across the whole life cycle of an asset including consulting, advisory environmental services, intelligent networks cybersecurity, design engineering, procurement, project construction management, operations maintenance, decommissioning and capital. The breadth and depth of our capabilities are delivered to clients in key strategic sectors such as Engineering Services, Nuclear, Operations Maintenance and Capital. News and information are available at www.atkinsrealis.com or follow us on LinkedIn. Our teams are proud to deliver on some of the most prestigious projects across the world. Its thanks to our talented people and their diverse thinking, expertise, and knowledge. Join us and youll be part of our genuinely collaborative environment, where everyone is supported to make the most of their talents and expertise. When it comes to work-life balance, AtkinsR alis is a great place to be. So, lets discuss how our flexible and remote working policies can support your priorities. Were passionate about are work while valuing each other equally. So, ask us about some of our recent pledges for Womens Equality and being a Disability Confident and Inclusive Employer . Support and assist regional project management teams to manage and control their documentation of customers and vendors i.e. proposals, product related issues and drawings/documents in a timely and efficient manner. Roles and Responsibilities: Maintain a Master Document Register (MDR) consisting of drawings, specifications, procedures and plans. Examine documents such as blueprints, drawings, change orders, and specifications to verify completeness and data accuracy. Follow-up with all the stakeholders to monitor and closure as per the schedule of due dates for drawings, specifications, software, technical manuals, and other documents. Prepare and maintain a filing system in various collaboration platforms e.g. Aconex, SharePoint as per project requirements. This filing system allows management team to get an updated Customer Supplier issued documents as receiving, recording, and processing for internal and external organizations review and approval. Manage the flow of correspondence in and out of the company through proper transmittals; ensure outgoing documents are accurate, comply with company standards and policies, route correspondence to correct associates; and protect and secure confidential and proprietary information. Copy or scan materials; organize, maintain, and safeguard files and database. Review and verify project documents for completeness, format, and compliance with contract requirements. Submit project documentation to management team for their approval and transmit approved documents to customer. Distribute documentation to the project team and customers for their review and comments. Receive, distribute, and track comments received from customers. Liaise with engineers, managers, customers, and other stakeholders to discuss the project, prepare documents, or modify contract schedules. Liaise with document originators or engineer s liaison personnel to resolve discrepancies and compiles required changes to documents. Update changes of computerized or manual control records; release documents and notify the affected departments. Provide support to other departments within the framework of the project e.g. assisting flow of company info. Minimum Qualification and Experience: Graduate in any discipline. Must have solid experience of 5+ years of experience in Document Control in engineering, manufacturing or construction. Other skills Adaptability to cope with diverse systems and procedures applicable to a variety of projects. Demonstrated ability to communicate effectively both verbally and in writing. Willing and proactiveness to work under tight deadlines and taking ownership of the tasks assigned to him or her. Ability to manage the document control process independently with minimum supervision. Ability to utilize Word, Excel, PowerPoint, etc. as tools to enable effective evaluation of information and reporting to Management. Preferred Tools: MS Office tools: MS Teams, Excel, Word, PowerPoint, etc. Aconex, ProjectWise, SharePoint, BIM360, ACC, Procore, Asite, Team Centre, EDMS What We Can Offer You: Varied, interesting and meaningful work. A hybrid working environment with flexibility and great opportunities. Opportunities for training and, as the team grows, career progression or sideways moves. An opportunity to work within a large global multi-disciplinary consultancy on a mission to change the ways we approach business as usual. Why work for AtkinsR alis We at AtkinsR alis are committed to developing its people both personally and professionally. Our colleagues have the advantage of access to a high ranging training portfolio and development activities designed to help make the best of individual s abilities and talents. We also actively support staff in achieving corporate membership of relevant institutions. Meeting Your Needs: To help you get the most out of life in and outside of work, we offer employees Total Reward. Making sure youre supported is important to us. So, if you identify as having a disability, tell us ahead of your interview, and we ll discuss any adjustments you might need. Additional Information: We are an equal opportunity, drug-free employer committed to promoting a diverse and inclusive community - a place where we can all be ourselves, thrive and develop. To help embed inclusion for all, from day one, we offer a range of family friendly, inclusive employment policies, flexible working arrangements and employee networks to support staff from different backgrounds. As an Equal Opportunities Employer, we value applications from all backgrounds, cultures, and ability. We care about your privacy and are committed to protecting your privacy. Please consult our Privacy Notice on our Careers site to know more about how we collect, use, and transfer your Personal Data. Link: Equality, diversity inclusion | Atkins India (atkinsrealis.com) Worker Type Employee Job Type Contractual (Fixed Term) At AtkinsR alis , we seek to hire individuals with diverse characteristics, backgrounds and perspectives. We strongly believe that world-class talent makes no distinctions based on gender, ethnic or national origin, sexual identity and orientation, age, religion or disability, but enriches itself through these differences.

JOB DESCRIPTION Job Title: Specialist Development QA Development Chemistry Department: Discovery and Development QA Job Location: Bengaluru, India About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit The mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned. Contributing to the development of procedures, practices and systems that ensure safe operations and compliance with the company s integrity quality standards. Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline always in the workplace. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace. Ensure that all assigned mandatory training related to data integrity, health, and safety measures is completed on time by all team members, including self. Compliance with Syngene s quality standards at all times. Hold yourself and your teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time. Core Purpose of the Role: Key Responsibilities: Responsible for driving Phase gate for Product Development across Chemical Development functions. Review and Assess risk associated with Analytical Methods and Mitigation Plan. Review and provide inputs on analytical methods to have robust methods. Review and approval of Analytical Technology Transfer from Development services to Quality Control. Review and approval of Method transfer documents and Specifications for all early and late phase programs. Review and approval of Method development reports and QbD reports during Method development. Review and approval of Process development reports and QbD reports during Process development. Coordination with cross-functional teams to complete the assigned work on time and data review. Responsible for reviewing scientific experiments as per project requirements in an analytical laboratory catering to large molecule process development. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges Review of Quality Assurance procedures in EDMS. Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company s integrity quality standards. Providing the exact root cause for the issues and performing why-why analysis to understand the challenges Review and implementation of cross-deployment of CAPAs across Development OUs. Support for facing Customer audits and their related compliance. Support for handling customer queries related to quality compliance with Development OUs. Overall adherence to safe practices and procedures of oneself and the teams aligned Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance with Syngene quality standards and Data integrity policies always. Hold self-accountable for the achievement of safety goals The Successful Applicant A minimum of 10 -15 years of experience in the pharmaceutical industry in Analytical Method development and Quality Control in small molecules, with at least 5- 10 years of testing experience. Proven track record of successfully managing and leading respective time. Sound knowledge of analytical techniques, including RS, Elemental impurities, Assay, Solubility studies, and impurity characterization. Sound knowledge of Guidelines such as ICH, USP etc. Strong understanding of regulatory requirements Excellent communication, Interpersonal and problem-solving skills Ability to work effectively with cross-functional teams and OU s. Technology Transfer/ Method Transfer from development to QC lab Knowledge of setting acceptance criteria for method validation and transfers. Ability to Handle method transfer and data review as part of the transfer. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience 10 -15 years of relevant experience Skills and Capabilities Team player, Result-oriented and focused. Education Master s degree in Pharmacy, Master s in chemistry are both preferable Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Position: Executive / Sr. Executive Job Title: Executive / Sr. Executive Job Grade: Function: R&D Quality Sub-function: CMCQA Formulation Manager s Job Title: DGM Skip Level Manager s Title: NA Function Head Title: AVP Location: Vadodara No. of Direct Reports (if any) NA Areas of Responsibility Review of various formulation and packing development / technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol / report, Master packaging record, Study Protocol & report etc. as per internal guidance and procedures for various markets To assist in developing procedures / system and for assuring compliance to them by the R&D function by identifying GAP and bridging through document review/audit To work in coordination with Team members and CFT to resolve issues. Evaluation of OOS/OOT data Departmental Training Coordinator in Learning Management System as per defined role like assign job to a user, add / removal of user to a job, assign learning activity to a job, to create curriculum). Function as EDMS coordinator Prepare departmental internal report for management information Travel Estimate Nil Job Scope Internal Interactions (within the organization) Various R&D and Site Functions External Interactions (outside the organization) Not Applicable Geographical Scope India Financial Accountability (cost/revenue with exclusive authority) NA Job Requirements Educational Qualification M. Pharmacy Specific Certification Six sigma or equivalent Skills Technical understanding, Oral and Written Communication Experience 5 to 7 years Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Urgent Hiring: Document Controller | Mumbai | MNC Company. Location: Mumbai Experience: 7-12 years Qualification: Any Graduate Job Responsibilities: Project Documentation Management: Organize, control, and manage all project-related documents. Electronic Document Management System (EDMS): Handle and maintain the document control system efficiently. Reporting & Compliance: Prepare document status reports, procedures, and instructions for project document management. Stakeholder Communication: Coordinate with internal teams and external stakeholders, including clients, contractors, subcontractors, and vendors. Training & Implementation: Present and train internal & external stakeholders on the document management system. Why Join Us? Opportunity to work with a leading MNC in a dynamic and professional environment. Enhance your career with global-standard document management practices . Be a key part of high-impact project documentation and compliance . Kindly note : we required local Mumbai candidates. Interested? Apply Now! Send your resume to tanvi.bhosale@aarviencon.com Contact for more info: +91 2243324722 Don't miss this opportunity to advance your career in document control! key skills : Primary Skills (Core Competencies): Document Control Electronic Document Management System (EDMS) Project Documentation Document Management System (DMS) Document Review & Approval Process Project Coordination Document Archiving & Retrieval ISO Documentation & Compliance Technical Skills: MS Office (Excel, Word, PowerPoint, Outlook) AutoCAD (if applicable for document handling) SharePoint / Aconex / Primavera Unifier / Asite (or other EDMS tools) ERP & SAP (if applicable for document tracking) Soft Skills: Communication & Coordination Stakeholder Management Training & Presentation Skills Attention to Detail & Accuracy Time Management & Organization

Designation: Associate Manager QA Job Location : Mangalore Department: MSEZ- Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve RD productivity, speed up time to market and lower the cost of innovation. Job Purpose: Associate Manager - Quality Assurance to manage QMS activities Educational Qualification: M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree. Experience: 8 to 12 Years Technical Skill: Participation in regulatory inspections and audits and managing responses and corrective actions. Ensuring compliance with data integrity policy and identifying the cause of non-compliance. Responsible for all engineering quality assurance activities and not limited to: Review and approval of Calibration / PM planners and schedule/ Engineering and Maintenance documents/ SOPs of Engineering and Maintenance. Review and approval of Information Technology related documents Handling of LMS Training Activities. Compilation and Preparation of Quarterly QMS trends Preliminary review of Quality notifications (such as Change control, Deviation, CAPA, Customer complaints, OOS, OOT) for its completeness and correctness. Preparation and review of Quality Agreement. Client communication. Vendor Qualification. Preparation and/or review and/or approval of Standard Operating procedures and ensuring the adherence to the guiding SOP. Review and approve of equipment qualification and engineering related validation documents for its adequacy and accuracy. Reviewing the risk assessments for its adequacy and accuracy. Familiar with Trackwise, EDMS, SAP and LMS applications. Key Responsibilities: Establishing and maintaining a robust QMS in accordance with regulatory requirements (e.g., ICH, FDA, EMA). Management of Site QMS and trending. Management of document archival. Site Training coordinator. Technical/functional Skills: Good communication skills and experience in API industry. Behavioural Skills: Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be able to work in team and flexible for working in shifts. Should be a focused employee. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

" 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 Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma 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 Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), 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 Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design & Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R&D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R&D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy. Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to on the job trainings and off the job trainings . Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech Chemical Engineering Experience Range : 10+ years Jubilant is an equal opportunity employer. .

Document collection& Distribution: Collect& register technical documents& Print& distribute. Document storage: Sort& store documents. Document review: Review& update documents . Document scanning: Scan& upload documents. Document filing &compliance. Required Candidate profile Must be willing to work beyond Office hours 4+ Years experience in Oil&Gas Sector Companies or Engg. Co. Technical qualification like Diploma would be advantageous Should be well versed in Computers.

Proficiency in Oracle Unifier system with proficiency. Good knowledge of using EDMS (Electronic Document Management System), PDMS (Project Document Management System), IM (Information Management), Documentation Management System, MS Office (Word, Excel, Power point, Outlook, Access) and SharePoint. Maintaining and managing all important documents either for a particular project or whole organization and assures accessibility and stored properly. In Oracle Primavera Unifier assign and closed RFI, SRR and letter correspondence MOMs and coordinate in site. Controlling EMS administer incoming and outgoing financial documents (submittals, transmittals, specifications, correspondences etc). Copy and distribute drawings and documents to relevant client on project site. Follow up for priority items with relevant managers, engineers, consultants, and contractors. Convert drawings to various file formats and upload / file as required. Makes sure that the documents and drawings are under safe custody without any damage or deterioration with easy traceability. Maintain the files and control logs as required by the project. Coordinate with consultant and client for contractor submittals approvals. Coordinate with Manager Document Control to ensure knowledge of EDMS and PMIS policy, procedures, reports etc. Coordinate all activities related to document control procedure, including technical documents, drawings, and commercial/ admin. site correspondence. Conduct periodic data checks and validation to ensure data accuracy. Input document data into the standard registers ensuring all the information is accurate and up to date. Ensure accurate and timely processing of data reports for head office as required. Ensure timely transmission of approved project change orders to the concerned stakeholders as per Communication Management Plan. Ensure that controlled copies of latest approved documents and drawings are given to the appropriate staff, subcontractors, and suppliers as applicable. Prepare and generate the various document control reports as required. Typing of site documents, and follow-up of all the site needs. Having strong interpersonal and communication skills, knowledge of Microsoft package, outlook and Oracle Primavera Unifier/ERP.

1. Engineering Document Control 2. Project Documentation 3. Technical Drawings & Records Management 4. Document Review & Approval Workflow 5. Compliance & Regulatory Documentation 6. ISO Standards & Audits 7. Electronic Document Management (EDMS) 8. Metadata & Version Control 9. Construction & Project Coordination 10. Vendor & Contractor Documentation Handling 11. AutoCAD & Blueprint Management

S&C Global Network - Strategy - MC - Industry X - Capital Projects - Analyst To bring industry knowledge, world class capabilities, innovation and cutting-edge technology to our clients in the capital projects industry to deliver business value To harness extensive knowledge combined with an integrated suite of methods, people and assets to deliver sustainable long-term solutions Lead design workshops, virtual walkthroughs and develop proof of concepts as required by the client teams Project Planning, monitoring and control through coordination/liasioning with various internal and external stakeholders. Handled team of more than 6+ resources Functional Processes/Domain experience across the project lifecycle- FEED, Engineering, Planning and Execution, Procurement & Supply Chain, Construction, Commissioning Planning & Execution, Budget and Cost Monitoring, Contract Lifecycle Management etc. Digital strategy and enablement across enterprise project functions (ex:Automation, IoT) and understanding of platforms like Hexagon, AVEVA Suites, Intergraph etc. would be desirable MIS and Reporting:Ability to drive & generate meaningful reports and apply analytical tools to carve out insights through reports, periodic reviews and meetings from top floor to shop floor (Ex:Engineering Analysis, Throughput, Contractor Performance, Project Performance Analysis, Milestone Analysis etc.) Qualifications Qualifications: Engineering Degree (Tier-1 institutes) MBA / PGDM (preferred) Experience: 10-16 years of experience in Project Design & Engineering for Capital Projects with strong understanding of managed services in Capital Build. Experience in delivering large-scale capital projects across Industry groups & geographies Minimum 5 years of experience in direct client facing role in Management Consulting firm having significant exposure on Design & Engineering Management The candidate should have excellent customer facing capabilities, and an established track record for selling delivering consulting engagements The individual must be comfortable working at the highest levels of client organizations and interacting closely with the C Suite executives End-to-end knowledge of project planning, monitoring and control (cost and / or schedule) from conceptualization to commissioning across Industries Should possess sound knowledge of Man-hour Budgeting, Quantity Reporting System, S Curve, Engineering Productivity Norms, Forecasting Techniques etc. Hands on experience & profound knowledge of working on Engineering Applications i.e., EDMS, Digital Twin, 3D Modelling etc. on Hexagon, AVEVA, Dassault etc. are must Experience in Solutioning & Implementation of at least 2 Products across various Industries & geographies Experience in visualization tools like Tableau, Power BI, QlickView etc. is an added advantage Experience in MS-Excel, MS- PowerPoint is mandatory. Additional experience in VB Scripts, Macros experience will be preferred. Certification as a Project Management Professional (PMP) else in Design & Engineering Product Function is desirable Key Competencies and Skills: Demonstrate expertise across one or more of following areas Enabling Engineering solutions through Automation using digital technologies such as Robotic Process Automation (Automation Anywhere, Blue Prism etc.) and Virtual Agent Implement digital tools and digital strategies for the clients Use of big data analytics to analyze and provide analytical data solutions Knowledge of IoT and related technologies to drive client discussions for digital enablement Knowledge of End to End Engineering Process & Workflows Knowledge of Advanced Work Packages, Digital Twin & Thread, Project Lifecycle Management Experience in emerging Digital engineering areas such as Generative redesign, Digital Twin, PLM etc. Integrate functional schedules towards developing the integrated project plan considering all the interdependencies and solving for inconsistencies across functional schedules Development of Unique Project Specific deliverables such as Operating Philosophy, Risk Register, Communication Matrix, PEP, specific Process & Procedures etc. Develop risk management plan and provide actionable items to higher management to ensure risk mitigation Understand, define and manage project scope including scope creep, scope change management and approvals Development of Project Status Dashboards, Red Flag Reports, Schedule Analysis & other various MIS reports covering major project progress aspects & criticalities

Extensive experience in Oracle E-Business Suite modules including Finance, Purchasing, Inventory, Projects, Payroll, PMS, EDMS, RIF, Calibration, and Invoice Register. Proficient in technical tools such as SQL, PL/SQL, Oracle Forms/Reports, and BI Publisher for effective system customization and reporting. Proven track record of successful Oracle E-Biz implementations and providing ongoing production support to ensure system stability and performance. Strong communication skills with the ability to articulate technical concepts to non-technical stakeholders and document processes effectively. Collaborative team player with a demonstrated ability to work across functional teams to drive project success and resolve issues. Work Mode - Freelance

About The Role : Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Individual contributor for Quality, Compliance, and Good Documentation Practices Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Primary Skills Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Secondary Skills Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Individual contributor for Quality, Compliance, and Good Documentation Practices

About The Role : Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Primary Skills Validation SME Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards. Working on Defect Management, CAPA and Deviation documentation, review and approval. working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc. Secondary Skills Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices. Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc. Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed Sign & Approve request forms for HPQC as IT Compliance approver. Individual contributor for Quality, Compliance, and Good Documentation Practices

JOB DESCRIPTION Designation: EHSS- L D specialist Job Location: Bangalore Department: EHSS About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve RD productivity, speed up time to market and lower the cost of innovation . Job Purpose The purpose of the role is to implement and enforce safe work practices throughout the company. Key Responsibilities: Designing of e-learning courses, career plans, workshops To plan and drive Role Based Training Matrix (RBTM) Training content preparations for effective implementation. Prepare and execute trainers development programme. Training evaluation and certifications of all EHSS employees. Build rapport with employees and stakeholders Develop and implement learning strategies and programs Evaluate individual and organizational development needs with respect to EHSS Implement various learning methods companywide (e.g. coaching, OJT, online training) on EHSS aspects Assess the success of development plans and help employees make the most of learning opportunities Oversea the training needs identification and management Have a strong understanding of what the organization s objectives are and that they create training programs that are aligned with the objectives. Have a full understanding of the various business units and closely work with various leaders across the organization for their specific EHSS training requirements. Create EHSS training Programmes that are aligned with the organization s objectives and having a strong understanding of what these are Designing staple learning curriculums for all EHSS employees EHSS documentation, GxP in Trackwise (Change control, CAPA, Deviation, Audit observation closure) Non GxP EHSS documentation (CCF, CAPA, Deviation) Issuance and archival of documents Coordinate with Learning management system team and prepare quarterly training calendar for all OU s and share it with all concerned team members. Ensure current version of documents are maintained in Syngconnect. Coordinate with QA Trackwise and EDMS team to resolve issues. Coordinate with QA team to upgrade EHSS documentation SOP s to align with QA SOP s. Educational Qualification: BSc/MSc (Chemistry/ Environmental) / BTech/MTech (Chemical/ Environmental) Technical/functional Skills: Safe Systems of work (permit to work, risk assessment etc) Compliance (regulatory and internal) Knowledge on Environmental management Incident/Accident management Emergency management Experience: Above 10 years of relevant experience in EHSS Behavioral Skills: Communication Conflict Resolution Work-life balance Time-Management Self-improvement Stress Management Patience Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

To bring industry knowledge, world class capabilities, innovation and cutting-edge technology to our clients in the capital projects industry to deliver business value To harness extensive knowledge combined with an integrated suite of methods, people and assets to deliver sustainable long-term solutions Lead design workshops, virtual walkthroughs and develop proof of concepts as required by the client teams Project Planning, monitoring and control through coordination/liasioning with various internal and external stakeholders. Handled team of more than 6+ resources Functional Processes/Domain experience across the project lifecycle- FEED, Engineering, Planning and Execution, Procurement & Supply Chain, Construction, Commissioning Planning & Execution, Budget and Cost Monitoring, Contract Lifecycle Management etc. Digital strategy and enablement across enterprise project functions (ex:Automation, IoT) and understanding of platforms like Hexagon, AVEVA Suites, Intergraph etc. would be desirable MIS and Reporting:Ability to drive & generate meaningful reports and apply analytical tools to carve out insights through reports, periodic reviews and meetings from top floor to shop floor (Ex:Engineering Analysis, Throughput, Contractor Performance, Project Performance Analysis, Milestone Analysis etc.) Qualifications Qualifications: Engineering Degree (Tier-1 institutes) MBA / PGDM (preferred) Experience: 10-16 years of experience in Project Design & Engineering for Capital Projects with strong understanding of managed services in Capital Build. Experience in delivering large-scale capital projects across Industry groups & geographies Minimum 5 years of experience in direct client facing role in Management Consulting firm having significant exposure on Design & Engineering Management The candidate should have excellent customer facing capabilities, and an established track record for selling delivering consulting engagements The individual must be comfortable working at the highest levels of client organizations and interacting closely with the C Suite executives End-to-end knowledge of project planning, monitoring and control (cost and / or schedule) from conceptualization to commissioning across Industries Should possess sound knowledge of Man-hour Budgeting, Quantity Reporting System, S Curve, Engineering Productivity Norms, Forecasting Techniques etc. Hands on experience & profound knowledge of working on Engineering Applications i.e., EDMS, Digital Twin, 3D Modelling etc. on Hexagon, AVEVA, Dassault etc. are must Experience in Solutioning & Implementation of at least 2 Products across various Industries & geographies Experience in visualization tools like Tableau, Power BI, QlickView etc. is an added advantage Experience in MS-Excel, MS- PowerPoint is mandatory. Additional experience in VB Scripts, Macros experience will be preferred. Certification as a Project Management Professional (PMP) else in Design & Engineering Product Function is desirable Key Competencies and Skills: Demonstrate expertise across one or more of following areas Enabling Engineering solutions through Automation using digital technologies such as Robotic Process Automation (Automation Anywhere, Blue Prism etc.) and Virtual Agent Implement digital tools and digital strategies for the clients Use of big data analytics to analyze and provide analytical data solutions Knowledge of IoT and related technologies to drive client discussions for digital enablement Knowledge of End to End Engineering Process & Workflows Knowledge of Advanced Work Packages, Digital Twin & Thread, Project Lifecycle Management Experience in emerging Digital engineering areas such as Generative redesign, Digital Twin, PLM etc. Integrate functional schedules towards developing the integrated project plan considering all the interdependencies and solving for inconsistencies across functional schedules Development of Unique Project Specific deliverables such as Operating Philosophy, Risk Register, Communication Matrix, PEP, specific Process & Procedures etc. Develop risk management plan and provide actionable items to higher management to ensure risk mitigation Understand, define and manage project scope including scope creep, scope change management and approvals Development of Project Status Dashboards, Red Flag Reports, Schedule Analysis & other various MIS reports covering major project progress aspects & criticalities

Management and Planning: Ability to execute assigned tasks independently Adherence to agreed timelines and proactive communication of any potential risk to the same, follow up with cross functional contributors on their deliverables in a proactive and timely manner Strong project management and documentation skills, proactive communication approach Maintain appropriate risk assessment and mitigation in cooperation with line manager /team lead Ability to work within a matrix organisation, build relationships with internal or external stakeholder Provide high quality deliverables as per company standards, right first time Profound knowledge of the companys systems and databases (APT, Trackers, RIMS/Veeva, EDMS) Familiar with the organization and able to identify relevant contributors and stakeholders within the organization as per project Providing Regulatory expertise into the planning and execution of projects and tasks Acts as a role model and helps the more junior staff to improve their business communication skills Encourages team/peers to take an active role in networking activities within own area of specialization/ project environment Focuses on facts and quality of work rather than origin of ideas (does not follow cultural stereotypes) Recognizes other s point of view and makes sure that everyone is listened to and understood Demonstrates high proficiency and delivers high quality influential presentations within the own area of specialization/ project environment Facilitates effective teamwork in own area/project by unearthing and managing conflicts effectively Pursues active networking within and often beyond disciplines/ areas, projects Reaches out to international colleagues and plays an active role in the international expert community Systems and Applications: Upon completion of a dedicated training, user can perform routine/ standard activities within the RA systems with no supervision required The output of the user will usually undergo standard QC/spot check procedure Regulatory Expertise: Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements Understanding of Regulatory Agencies structure, processes and key personal as applicable In Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request Pharma business acumen: Have a good understanding on how business operates and makes smart decisions trying to see the big picture without losing view of the details Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers Practical experience in one of the following areas for synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management In-depth knowledge of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries Position may require both domestic and international travel Qualification: Degree in Pharmacy or Life Science, Medical, PharmD or related discipline (minimum MPharm or MSc or equivalent degree), higher degree preferable (eg PhD in a scientific discipline) Experience Required: More than 7 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role Minimum 3 years of Global CMC regulatory experience User has advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint) User has contributor level of experience with RIMS / Veeva and EDMS RA application Key Skills: Experience in Regulatory Affairs CMC activities of Biologics / Biosimilars / Injectables is an added advantage to this position Experience in preparation and management of regulatory CMC documentation, including normally a full international submission (new product application) or complex variations Experience with life-cycle management activities in at least two regions (eg Europe, USA, International would be an asset) Experience with ROW countries and awareness of regulatory affairs CMC contribution to Pharma business Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc) and LCM strategies Communication and Collaboration: Excellent written and spoken English language

Business Information: The Hitachi Energy Indian Operations Center (INOPC) is a competence center with around 2600+ skilled engineers who focus on tendering, engineering, planning, procurement, functional system testing, installation super vision and commissioning. However, over the last decade, it has evolved to become the largest engineering hub. The India Operations Centre is a key aspect of the Power Grids business Power Up transformation program. The INOPC team at Chennai supports Hitachi Energy s units in more than 40 countries across a wide portfolio of all the four business units in Power Grid business. To date, the team has executed engineering and commissioning for projects in more than 80 countries. HVDC (High Voltage Direct Current) and HVDC Light are highly efficient alternatives for transmitting bulk power and for special purpose applications. The classic HVDC technology is used to transmit electric power over long distances by overhead transmission lines or submarine cables. It is also used to interconnect separate power systems, where traditional alternating current (AC) connections cannot be used. HVDC Light is an underground and submarine cable power transmission technology developed by Hitachi Energy that offers additional benefits compared to HVDC Classic. INOPC-HVDC is the operation center for Global HVDC, located in Chennai. This center operating since Sep 2007 and has grown in engineering skills and competence as fully integrated part of Global HVDC. Mission Statement: Project Document distribution to the internal team and externally to customers. Responsible to keep track of document status and provide inputs to project management and relevant parties Your Responsibilities: Profile & upload Drawing files, Manuals, Test Reports, Calculations etc. Upload the documents into the Document Control System (Database). Maintaining complete project documentation status. Communicating with Project Manager, Document Coordinators, Purchase in-charge and Line Departments for clarifications and suggestions. Proper follow-up with other dept to submit the document. Living core values of safety and integrity, which means taking responsibility for your own actions while caring for your colleagues and the business. Your Background: Any bachelors degree with minimum of 2 to 5 years experience in Documentation Management. You should have experience in contract reading and understand the Customer documentation requirements. Should have strong knowledge in MS Excel, Word and PPT, EDMS etc. Excellent written and verbal communication skills. Should be a team player. Should have good experience in preparing a report and maintaining the record. .

ERP/EPM/BI applications • Experience in building and leading large-scale MDM implementation projects • Strong understanding of data governance concepts and master data management best practices

Provides support for Enterprise Content Management Systems (ECMS) such as Aconex and InfoWorks and archival/retention management systems such as DocFinity, and other associated tools Interacts with end users to support, troubleshoot, and resolve issues Education and Experience Requirements: 6-8 yrs. Of working experience in Document Management. Required Knowledge, Skills, and Abilities: Experience in EPC industry is desirable Experience in using standard Electronic Document Management System (EDMS) to register, control, distribute, transmit and archive project records. Plans, controls, and carries out records management and administrative activities for the project for one or more key result areas, e.g., document control, communications control, file administration, or client administrative support. Proven capability of processing a high volume of supplier and/or project documentation. Develop and support the implementation of the records retention and turnover plans. Work in team environment and provide training on Work process and tools.