242 Edms Jobs

Manage, register, file & retrieve project documentation Manage / prepare internal & external transmittals Issue documents, queries & formal letters Sent & received documents tracking File & maintain all electronic & hard copy files Edit files Required Candidate profile DIP/BSc/BE 4+yrs exp with ENGG / PROCESS industry into Documentation / Inside Sales Strong skills in Electronic Document Management Systems (EDMS), MS Office, English Language, Presentation etc Perks and benefits Excellent Perks. Send CV to cv.ch1@adonisstaff.in

Implement and maintain document control processes and procedures Develop and maintain the Document Management System Manage all flows of documents in electronic form and on paper support Required Candidate profile Ensure Document Management accordingly to established procedures or standards (documents numbering, formats, issuance, review, dispatch, recording and archiving)

The opportunity: Project Document distribution to the internal team and externally to customers. You will be responsible to keep track of document status and provide inputs to project management and relevant parties. How youll make an impact: You will profile & upload Drawing files, Manuals, Test Reports, Calculations etc. You will upload the documents into the Document Control System (Database). You will be maintaining complete project documentation status. You will be communicating with Project Manager, Document Coordinators, Purchase in-charge and Line Departments for clarifications and suggestions. You will follow-up with other departments to submit the document. You will be responsible to ensure compliance with applicable external and internal regulations, procedures, and guidelines. Living Hitachi Energys core values of safety and integrity, which means taking responsibility for your own actions while caring for your colleagues and the business. Your background: You hold a bachelor s degree. Minimum 2 to 5 years of experience in Documentation Management. Should have experience in contract reading and understand the documentation requirement. Experience in Oil & Gas Industries, power related Industries is preferred. Should have strong knowledge and experience in MS Office: Word, Excel, PPT, EDMS. Should have good experience in preparing reports and maintaining the record. Strong attention to detail , should be a team player, ability to communicate effectively and understand the other requirement. Excellent written and verbal communication skills. Qualified individuals with a disability may request a reasonable accommodation if you are unable or limited in your ability to use or access the Hitachi Energy career site as a result of your disability. You may request reasonable accommodations by completing a general inquiry form on our website. Please include your contact information and specific details about your required accommodation to support you during the job application process. .

Job Title: Executive / Sr. Executive QA Business Unit: Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc. ) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M. Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! 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).

Job Title: Executive / Sr. Executive QA Business Unit: Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc. ) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M. Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! 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).

Role Overview: You will be responsible for managing the distribution of project documents to the internal team and external customers. Your role will involve maintaining document status, uploading various files into the Document Control System, and ensuring compliance with regulations and guidelines. Key Responsibilities: - Profile & upload Drawing files, Manuals, Test Reports, Calculations, etc. - Upload documents into the Document Control System and maintain complete project documentation status. - Communicate with Project Manager, Document Coordinators, Purchase in-charge, and Line Departments for clarifications and suggestions. - Follow up with other departments to submit required documents. - Ensure compliance with applicable external and internal regulations, procedures, and guidelines. - Demonstrate effective communication skills and understanding of requirements. - Uphold core values of safety and integrity by taking responsibility for actions and caring for colleagues and the business. Qualifications Required: - Bachelor's degree with 2 to 5 years of experience in Documentation Management. - Experience in reading contracts and understanding Customer documentation requirements. - Strong knowledge of MS Excel, Word, PPT, EDMS, etc. - Excellent written and verbal communication skills. - Ability to work well in a team environment. - Experience in preparing reports and maintaining records.,

Implement and maintain document control processes and procedures Develop and maintain the Document Management System Manage all flows of documents in electronic form and on paper support Required Candidate profile Ensure Document Management accordingly to established procedures or standards (documents numbering, formats, issuance, review, dispatch, recording and archiving)

Job Purpose To provide efficient Document Control in support of Engineering team to enable up to date drawings/documents to be available Aims and Objectives Document control & administration of Electronic Document Control System. migration of current windows file system engineering as built data to EDMS system Key Responsibilities and Accountabilities Document Control & Administration of Electronic Document Control System. and windows file system. with migration of Current windows file system to EDMS. Administer the engineering (EDMS) Electronic Document Control System and control of client sourced drawings Technical Manuals and Ad Hoc documents receipts-inwards/issues-outwards. Respond to document requests from client and client appointed consultants search/find and issue and issue via EDMS and other systems in a controlled recorded manner. Data preparation and compile drawing registers from existing windows file structure. Receive and Register and check/report that the format of incoming completed Projects supplied by client appointed contractors meets Client requirements for EDMS. Prepare & report on documentation Health & Safety/BAU/Statutory/Critical documentation as required by the business. Ensure a thorough understanding of the Client (EDMS) via training programme. Receive and take messages/Document requests and where appropriate take action. To carry out ad hoc duties not listed above as required by the Document Manager or General & Senior Management. Work with EDMS vendor to build the client system and take over full administrative responsibility for its management once handed over. Health & Safety All staff are required to fulfil their legal duty to take reasonable care for the health and safety of themselves and others who may be affected by their acts and omissions, and to follow all guidance and instructions given in this respect. Further details regarding Health & Safety responsibilities are set out in the Health & Safety Policy. People Skills To interface with peers, seniors, client vendors and build good working relationships with same Integrity: keep information confidential where required Experience, Knowledge and Skills Essential : Graduation in Mathematics & English Proficient in Excel/Word. Basic Technical Knowledge Building Services Previous Document Control Experience 3-5 years of Document Control Experience Desirable : A Level passes or recognized equivalent B-Tech Qualification Knowledge of ISO standard 19650 Basic understanding of BIM and Asset management Knowledge and Skills : Ability to read and interpret technical manuals and drawings Excellent written and verbal communication skills. Ability to prioritize work tasks. Adaptable and flexible in approach to work required. Effective problem-solving skills. Be able to read and save cad drawings in dwg format. Reliable -Meeting deadlines and good time management. Detail conscious. Results/tasks orientated. Background knowledge/understanding or engineering or maintenance desirable. Knowledge of workplace computer systems. Experience in a similar position would be highly desirable. Confidence and commitment to providing a high quality, professional service. Excellent customer Service skills - ability to build and maintain rapport. Ability and readiness to give instruction to peers-colleagues. Scheduled Weekly Hours: 40

Job Purpose To provide efficient Document Control in support of Engineering team to enable up to date drawings/documents to be available Aims and Objectives Document control & administration of Electronic Document Control System. migration of current windows file system engineering as built data to EDMS system Key Responsibilities and Accountabilities Document Control & Administration of Electronic Document Control System. and windows file system. with migration of Current windows file system to EDMS. Administer the engineering (EDMS) Electronic Document Control System and control of client sourced drawings Technical Manuals and Ad Hoc documents receipts-inwards/issues-outwards. Respond to document requests from client and client appointed consultants search/find and issue and issue via EDMS and other systems in a controlled recorded manner. Data preparation and compile drawing registers from existing windows file structure. Receive and Register and check/report that the format of incoming completed Projects supplied by client appointed contractors meets Client requirements for EDMS. Prepare & report on documentation Health & Safety/BAU/Statutory/Critical documentation as required by the business. Ensure a thorough understanding of the Client (EDMS) via training programme. Receive and take messages/Document requests and where appropriate take action. To carry out ad hoc duties not listed above as required by the Document Manager or General & Senior Management. Work with EDMS vendor to build the client system and take over full administrative responsibility for its management once handed over. Health & Safety All staff are required to fulfil their legal duty to take reasonable care for the health and safety of themselves and others who may be affected by their acts and omissions, and to follow all guidance and instructions given in this respect. Further details regarding Health & Safety responsibilities are set out in the Health & Safety Policy. People Skills To interface with peers, seniors, client vendors and build good working relationships with same Integrity: keep information confidential where required Experience, Knowledge and Skills Essential : Graduation in Mathematics & English Proficient in Excel/Word. Basic Technical Knowledge Building Services Previous Document Control Experience 3-5 years of Document Control Experience Desirable : A Level passes or recognized equivalent B-Tech Qualification Knowledge of ISO standard 19650 Basic understanding of BIM and Asset management Knowledge and Skills : Ability to read and interpret technical manuals and drawings Excellent written and verbal communication skills. Ability to prioritize work tasks. Adaptable and flexible in approach to work required. Effective problem-solving skills. Be able to read and save cad drawings in dwg format. Reliable -Meeting deadlines and good time management. Detail conscious. Results/tasks orientated. Background knowledge/understanding or engineering or maintenance desirable. Knowledge of workplace computer systems. Experience in a similar position would be highly desirable. Confidence and commitment to providing a high quality, professional service. Excellent customer Service skills - ability to build and maintain rapport. Ability and readiness to give instruction to peers-colleagues. Scheduled Weekly Hours: 40

remote typeRemote locationsBengaluru, KA time typeFull time posted onPosted 2 Days Ago job requisition idREQ414676 We are seeking a highly skilled and experienced individual to join our organization as a Global Document Management System Lead. As the Global Document Management System Lead, you will be responsible for overseeing the implementation, administration, and optimization of our organization's document management systems across multiple locations worldwide. You will collaborate with cross-functional teams to identify requirements, design solutions, and provide ongoing support to ensure efficient document management processes and compliance. Responsibilities Document Management System Implementation 5+ Years of experience in document management Lead the implementation of a centralized document management system across the organization. Define project scope, objectives, and deliverables. Collaborate with stakeholders to gather requirements and ensure system alignment with business needs. Develop implementation plans, including timelines, resource allocation, and key milestones. Coordinate and oversee system configuration, testing, and user training. Ensure successful system migration from legacy platforms. Ensure that all documents such as engineering specifications and designs, contracts, policies, procedures, standard operating procedures, process flow chart, and work instructions (including test procedures) are under configuration control and are available to all necessary personnel in the Client environment. Interface with other Client and JLL departments as necessary to ensure proper development, execution, and adjustment of records management program policies and tools. Manage legal/audit holds of Client records, as required by the Client. Operate and maintain a document management system for the effective updating/removal of any obsolete documentation. Documentation support and maintenance of Client documentation (physical and electronic) related to facilities operations, capital projects, and audits, including, but not limited to Engineering and project drawings management and support Specifications management and support Operational document management and support Capital project document management and support. Digitisation support Project Management, Capital Management, Property Asset Management and Corporate Real Estate Services Building Information Modelling documents Contract documentation management and support Facility required licenses and certifications. System Administration and Support Manage the day-to-day administration of the document management system. Establish and enforce document management policies, procedures, and best practices. Provide ongoing support to end-users, addressing system issues, troubleshooting, and resolving user inquiries. Conduct regular system audits to ensure data integrity, system performance, and compliance with regulatory requirements. Monitor system usage and user adoption, identifying opportunities for improvement and efficiency. Collaboration and Change Management Collaborate with cross-functional teams, including IT, Legal, Compliance, and Operations, to understand business requirements and align document management practices accordingly. Develop and deliver training programs to educate users on proper document management procedures and system functionality. Lead the change management efforts related to the adoption of the document management system, ensuring user buy-in and fostering a culture of continuous improvement. System Optimization and Upgrades Stay current with industry trends, emerging technologies, and best practices in document management systems. Identify opportunities for system optimization, enhancements, and upgrades to support evolving business needs. Work closely with IT teams and vendors to evaluate and implement system upgrades and integrations, as required. Conduct system performance evaluations and implement strategies to optimize system efficiency and user experience. Qualifications Bachelor's degree in any related field. Proven experience as a system administrator or lead role in implementing and supporting document management systems at a global scale. Strong technical proficiency and expertise in document management systems, such as SharePoint, OpenText, or similar platforms. Excellent project management skills, with the ability to effectively manage multiple priorities and deadlines. Solid understanding of document management workflows, information governance, compliance frameworks, and data security. Familiarity with document imaging technologies and concepts. Experience in change management and end-user training. Strong analytical and problem-solving abilities. Exceptional communication and interpersonal skills, with the ability to collaborate across various teams and stakeholders. Detail-oriented, with a commitment to accuracy and quality. If you are an experienced professional with a passion for implementing efficient document management systems in a global context, we encourage you to apply for the role of Global Document Management System Lead. Join our team and contribute to streamlining our organization's document management practices on a global scale. Top of Form Location Remote Bengaluru, KA Scheduled Weekly Hours: 40 JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLLs recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. For more information about how JLL processes your personal data, please view our . For additional details please see our career site pages for each country. For candidates in the United States, please see a full copy of our Equal Employment Opportunity and Affirmative Action policy . Jones Lang LaSalle (JLL) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process including the online application and/or overall selection process you may contact us at . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our page > I want to work for JLL.

remote typeRemote locationsBengaluru, KA time typeFull time posted onPosted 2 Days Ago job requisition idREQ414676 We are seeking a highly skilled and experienced individual to join our organization as a Global Document Management System Lead. As the Global Document Management System Lead, you will be responsible for overseeing the implementation, administration, and optimization of our organization's document management systems across multiple locations worldwide. You will collaborate with cross-functional teams to identify requirements, design solutions, and provide ongoing support to ensure efficient document management processes and compliance. Responsibilities Document Management System Implementation 5+ Years of experience in document management Lead the implementation of a centralized document management system across the organization. Define project scope, objectives, and deliverables. Collaborate with stakeholders to gather requirements and ensure system alignment with business needs. Develop implementation plans, including timelines, resource allocation, and key milestones. Coordinate and oversee system configuration, testing, and user training. Ensure successful system migration from legacy platforms. Ensure that all documents such as engineering specifications and designs, contracts, policies, procedures, standard operating procedures, process flow chart, and work instructions (including test procedures) are under configuration control and are available to all necessary personnel in the Client environment. Interface with other Client and JLL departments as necessary to ensure proper development, execution, and adjustment of records management program policies and tools. Manage legal/audit holds of Client records, as required by the Client. Operate and maintain a document management system for the effective updating/removal of any obsolete documentation. Documentation support and maintenance of Client documentation (physical and electronic) related to facilities operations, capital projects, and audits, including, but not limited to Engineering and project drawings management and support Specifications management and support Operational document management and support Capital project document management and support. Digitisation support Project Management, Capital Management, Property Asset Management and Corporate Real Estate Services Building Information Modelling documents Contract documentation management and support Facility required licenses and certifications. System Administration and Support Manage the day-to-day administration of the document management system. Establish and enforce document management policies, procedures, and best practices. Provide ongoing support to end-users, addressing system issues, troubleshooting, and resolving user inquiries. Conduct regular system audits to ensure data integrity, system performance, and compliance with regulatory requirements. Monitor system usage and user adoption, identifying opportunities for improvement and efficiency. Collaboration and Change Management Collaborate with cross-functional teams, including IT, Legal, Compliance, and Operations, to understand business requirements and align document management practices accordingly. Develop and deliver training programs to educate users on proper document management procedures and system functionality. Lead the change management efforts related to the adoption of the document management system, ensuring user buy-in and fostering a culture of continuous improvement. System Optimization and Upgrades Stay current with industry trends, emerging technologies, and best practices in document management systems. Identify opportunities for system optimization, enhancements, and upgrades to support evolving business needs. Work closely with IT teams and vendors to evaluate and implement system upgrades and integrations, as required. Conduct system performance evaluations and implement strategies to optimize system efficiency and user experience. Qualifications Bachelor's degree in any related field. Proven experience as a system administrator or lead role in implementing and supporting document management systems at a global scale. Strong technical proficiency and expertise in document management systems, such as SharePoint, OpenText, or similar platforms. Excellent project management skills, with the ability to effectively manage multiple priorities and deadlines. Solid understanding of document management workflows, information governance, compliance frameworks, and data security. Familiarity with document imaging technologies and concepts. Experience in change management and end-user training. Strong analytical and problem-solving abilities. Exceptional communication and interpersonal skills, with the ability to collaborate across various teams and stakeholders. Detail-oriented, with a commitment to accuracy and quality. If you are an experienced professional with a passion for implementing efficient document management systems in a global context, we encourage you to apply for the role of Global Document Management System Lead. Join our team and contribute to streamlining our organization's document management practices on a global scale. Top of Form Location Remote Bengaluru, KA Scheduled Weekly Hours: 40 JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLLs recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. For more information about how JLL processes your personal data, please view our . For additional details please see our career site pages for each country. For candidates in the United States, please see a full copy of our Equal Employment Opportunity and Affirmative Action policy . Jones Lang LaSalle (JLL) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process including the online application and/or overall selection process you may contact us at . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our page > I want to work for JLL.

Description Burns & McDonnell India (BMI) Power Division is looking for Document Controller in Project Services department at our Mumbai Office. The Power Division focuses on power generating facilities, which offer a wide range of design and project execution experiences. Power group is involved in design and evaluation of mechanical systems associated with coal and natural gas-fired power generation facilities as well as associated support facilities (i. e. Gas turbines, Steam Turbines, Heat Recovery Generators and Balance of plant equipment to be designed and constructed as per applicable codes and standards). Following are some specific duties & responsibilities: For timely, accurate and efficient preparation and management of documents. Develop and update the document control procedures and guidelines to ensure the project team uses correct, consistent, and standardized processes. Identify gaps and provide instructions and trainings to different disciplines to improve document management processes. Provide training and guidance to external users to capture correct data exchange per contract. Review and update technical documents (e. g. manuals and workflows), Distribute project-related data to internal teams. Maintain Engineer and Vendor deliverables in the Electronic Document Management System (EDMS). Coordinate with Project Manager / Project Engineer and other discipline leads. Receive, log, track, file, and monitor engineering and supplier drawings in an EDMS. Respond to internal and external document control requests. Maintaining the security of confidential data. Assisting internal and external with EDMS permissions. Upon data completion assist in the preparation of data books with subsequent filing, scanning and generate transmittals as required. Assist with either or both hard copy or electronic turnover of documents. Qualifications Bachelor s degree in any Discipline, Library / Data Science Preferable Must have 4 - 6 years of Oil & Gas / Energy/Power / Construction / Manufacturing / Project Management Industry experience Excellent communication (Reading, Writing, and Speaking) skills. Interpersonal Skills Attention to detail Familiarity with project management Proficient computer skills, experience with MS Office, MS Word, MS Excel, PowerPoint etc Experience in Procore, Aconex and Hexagon SDx is highly preferred but not essential Knowledge of quality management and operating procedures Excellent organization and documentation skills Delivery-focused and deadline-oriented Problem solving Ready to be able to work in different shifts if necessary Job Engineering Primary Location India-Maharashtra-Mumbai Schedule: Contract Travel: No Req ID: 253602 Job Hire Type Contingent Worker (CWK) Not Applicable #BMI N/A

JOB DESCRIPTION Job Title: Junior Manager - Regulatory Affairs Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) 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 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 development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: The candidate will combine his/her knowledge of scientific & regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities. Role Accountabilities The candidate s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for: Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule & biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement. Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team. Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance. Interact with stakeholders, collate necessary document, Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures. Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management. Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed. Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines. Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted by the company. Traveling to other sites within Karnataka if necessary, though travel requirements are minimal. Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets Must have hands-on experience in investigational medicinal products and marketing authorization. Experience in Biologicals /ADC / veterinary drugs is a definite plus. Skills and Capabilities High-level English Proficiency in reading, writing, and communication Hands-on Experience in eCTD. Experience in RDMS, EDMS & QMS is definite plus. Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application Education B. Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science. 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

Job Description Position S0/ AM/ DM No. of Positions Department Direct Sales Force Function CAT-Elite Reporting to Branch Relationship Manager Band 5/5A/5B Location - Comp. Job Summary Is responsible for generating revenue by focussing on Service to sales through relationship management, sales productivity-per-executive, thereby achieving sales & service targets. Also has the flexibility to increase productivity and meet targets through self-sourced business from HNI clientele. Key Responsibilities Maintain Customer Relationship Build sustainable relationships and trust with customer via open and interactive communication Regular & timely interaction with the customer via various modes like calls, whatsapp, EDMs etc. as decided per the business plan Explain customized proposition to the customer basis the important dates (Birthday, Term Renew etc.) Perform annual protection review calls as per the timelines Campaign Calling Perform Segmented product based campaigns including GLIP, SWP, FWP and others Perform Service Request Calls Keep records of customer interactions and ensuring timely processing of client service request Handle customer complaints, provide appropriate solutions and alternatives within the time limits; follow up to ensure resolution Provide accurate, valid and complete information by using the right methods/tools Ensuring business hygiene by controlling vectors like 13 th month persistency, incident rate and free-looking etc. Essential Qualifications Graduate Good to Have Certifications in Financial markets like - AMFI/CFP, Gender Female (Preferred) Minimum 1 Yrs. of experience in selling any financial products Competence required Good Communication (Verbal & Written), Experience in selling multiple financial products, Interpersonal communication, Customer centricity, Experience in sales verticals dealing with HNI customers Job Description Position S0/ AM/ DM No. of Positions Department Direct Sales Force Function CAT-Elite Reporting to Branch Relationship Manager Band 5/5A/5B Location - Comp. Job Summary Is responsible for generating revenue by focussing on Service to sales through relationship management, sales productivity-per-executive, thereby achieving sales & service targets. Also has the flexibility to increase productivity and meet targets through self-sourced business from HNI clientele. Key Responsibilities Maintain Customer Relationship Build sustainable relationships and trust with customer via open and interactive communication Regular & timely interaction with the customer via various modes like calls, whatsapp, EDMs etc. as decided per the business plan Explain customized proposition to the customer basis the important dates (Birthday, Term Renew etc.) Perform annual protection review calls as per the timelines Campaign Calling Perform Segmented product based campaigns including GLIP, SWP, FWP and others Perform Service Request Calls Keep records of customer interactions and ensuring timely processing of client service request Handle customer complaints, provide appropriate solutions and alternatives within the time limits; follow up to ensure resolution Provide accurate, valid and complete information by using the right methods/tools Ensuring business hygiene by controlling vectors like 13 th month persistency, incident rate and free-looking etc. Essential Qualifications Graduate Good to Have Certifications in Financial markets like - AMFI/CFP, Gender Female (Preferred) Minimum 1 Yrs. of experience in selling any financial products Competence required Good Communication (Verbal & Written), Experience in selling multiple financial products, Interpersonal communication, Customer centricity, Experience in sales verticals dealing with HNI customers

We are looking for a highly skilled and experienced Specialist, Document Control to join our team at Herbalife Int India Pvt Ltd. The ideal candidate will have a strong background in document control and management, with excellent analytical and problem-solving skills. Roles and Responsibility Manage and maintain accurate and up-to-date records and documents. Develop and implement effective document control processes and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze and resolve complex document-related issues and discrepancies. Provide training and support to junior staff members on document control procedures. Ensure all documents are properly indexed, stored, and retrievable for future reference. Job Requirements Strong knowledge of document control principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills. Ability to maintain confidentiality and handle sensitive information. Proficient in using document control software and systems.

We are looking for a Document Controller to join our either at Chennai/ Gurgaon office and work within a functional team that is responsible for facilitating the document control management core functional processes at a project level in the planning, execution, and close-out phases. Together with customers, partners, and colleagues, we shape a future where people and societies grow and flourish. We do that by co-creating sustainable and beautiful solutions that improve the quality of life for people today and many generations ahead. Your key responsibilities will be: Management of the information flow between the delivery team and the client Maintaining a database of all incoming & outgoing documents in EDMS (ProjectWise, Asite, etc.) Preparing and maintaining a log of all incoming and outgoing documents. Liaising with and distributing project-related information with all levels of the project team and potentially external parties Communicating and collaborating with project managers. Copying, scanning, and uploading, and registering incoming and outgoing documents in EDMS Timely distribution of documents/reports to the enabling works team for review and providing tracking reports to the enabling works team identifying clients submissions Logging and distributing MoM, General Correspondence, letters, etc Drawing No. Requests (Dealing with drawing no. request on the project based on the Client Document Numbering System) Managing the authorization of new folders within the file structure and auditing the filing structure to ensure discipline and logic are being adhered Expediting Delivery team for various documents and coordinating internal review activities Your Skills, Our Team. Together we design the future The first step to success in this role is that you are eager to collaborate with the people around you, whether they are colleagues, partners, or customers. Developing ties with others is something you do by acting respectfully and delivering on your promises. And you never get set in your ways but keep exploring new insights and ways to improve. Moreover, you will have: Graduate degree with a minimum of 5 years of relevant experience with previous experience in a similar role on major infrastructure projects internationally Sound knowledge of document management standards, processes, and procedures Working knowledge of EDMS systems like ProjectWise, Asite, etc. Good Knowledge of Office 365 and advanced knowledge of Software systems (MS Office, Business Collaborator) Expertise in documentation processes within an engineering and construction environment and a knowledge of a typical project life cycle Ability to multitask and work independently without much guidance. A higher level of understanding of technical terms/ various document types related to the construction industry will be advantageous. Excellent written and verbal communication skills

In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices Knowledge of cGxP requirements, Quality related IT applications, and computer system validation and deployment Demonstrated experience with managing complex activities Must have international experience and experience working with large cross-functional teams Technical knowledge and expertise with Quality Management computer systems including Electronic Document Management Systems (EDMS)and Quality Management Systems (QMS) and processes (such as deviations, CAPA, laboratory investigations, complaints, trends, change control, document management, notification to health authorities, notification to Management, etc. ). Skilled with Excel, Word, PowerPoint, MS Project and SharePoint Demonstrates resourcefulness and initiative and creates an appropriate level of urgency to meet objectives and deadlines Fluent in English Verbal and written communication excellence required Veeva Quality system knowledge a plus Your experience and qualifications Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field Minimum of 5-7 years in pharmaceutical or related industry is required

Designation: Document Controller Qualification: Any Degree Experience : 5 to 8 yrs (Construction Experience Must) Salary : 2300 to 3500 AED (55,000 to 84,000 INR) Free Accommodation Employment Visa Contact & WhatsApp HR - Devi – 9629919194. Required Candidate profile Required Documents 1. Resume 2. Qualification Certificate 3. Experience Certificate 4. Passport contact & share your resume through Whatsapp - HR - Devi – 9629919194. Perks and benefits Free Accommodation and Transport

Overview Expleo has an exciting opportunity for Aerospace MRB Stress Concessions Engineers to work within the T300 MRB Concessions Team. Responsibilities Carry out static strength, stiffness and fatigue and damage tolerance calculations using a variety of hand calculation and computer methods for A350 fuselage detail & assembly manufacturing non-conformances. Ability to identify the most efficient methods for analysis whilst ensuring adherence to relevant airworthiness requirements. Liaising with the customer approvers (T400). Able to liaise with multiple functions/suppliers to ensure most appropriate solution is met with consideration to cost, time and performance requirements. Ability to explain and escalate critical issues and an ability to mentor others. Qualifications BTech Essential skills Good Knowledge on Aerospace domain, structure, loads & Aircraft drawing Experience working on Airbus concessions either directly for Airbus or the Supply Chain, for a minimum of three years and ideally having held a level of delegated technical approval. Knowledge across the A350 programme, preferably with both metallic and composite fuselage capabilities and the build sequence / process. Understanding of material properties, production methods and practices and their effect on aircraft performance. Knowledge & experience of Airbus concession repair philosophy Completed SAP PAC Training Course (21 STRU CONCESSION) and proficient at using SAP PAC for concessions processing. Working knowledge of ISAMI methods for static and fatigue analysis. Working knowledge of Airbus Harmonised Fatigue methods. A basic understanding of FE analysis including interrogation and post processing of results. Use of traditional reference data as well as Airbus specific data and the systems used to access these. Proficient in the use of SAP to process concessions. Proficient in the use of Microsoft Office. Tools are given below: SAP ISAMI ProductView Hypermesh Nastran/Patran Microsoft Office eDMS Airbus Supply Desired skills Knowledge of Airbus processes and procedures relating to concessions (A2406.2, M2223.1, M2223.2, ASR, IPC, etc.) Visual basic and or python programming knowledge. Automation of repeatable tasks / processes. Experience in initial Design Stress (Static, Fatigue and FEM) tasks of Aircraft Structures. Experience 6-10 Years

Location: Bangalore, KA, IN At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, 80,000 colleagues lead the way to greener and smarter mobility worldwide, connecting cities as we reduce carbon and replace cars. Could you be the full-time Documentation Management Specialist in our dynamic Project/Program team were looking for? Your future role Implement Documentation Management within the Project/Program/Bid organization (in Leading Unit and coordinate in all Participating Units). Monitor complete Project/ Program/Bid Documentation and execute Documentation Life Cycle with the Documentation Master List (DML) Support the Project/Program/Bid Documentation Manager (PrDM) of the relevant Project/Program/Bid Check internal validation (AVVA) of documents before submission to Customer. Accountable that the Project Documentation is properly archived Proactive role in the Project / Program / Bid in terms of implementation of documentation culture. Key accountabilities: Applies the rules defined in the Documentation Management Plan (DMP), Metadata Controls documentation standards: template, reference, version, Define and Deploy the Documentation numbering system Define and Deploy the Project Working documents single repository (in Teams, Sharepoint, etc...) Controls contractual documentation submissions according to customer requirements, Assigns reference, when needed, to the documentation produced and controls the electronic files identification and customer identification (if relevant), Checks the identification used by entities and partners, Records in the EDMS all technical and management documentation from external entities, Makes sure internal validation of Project/Program documents (AVVA) is done before submission to Customer. Completes/updates the DML (Documentation Master List) with data collected during the project and prepares the CDL. Prepares and records documents submission to Customer/Partners, Sends documentation according to internal distribution list, Provides inputs related to documentation dashboards and reports Follows Customer and stakeholders documentation status in DML. Updates the document contractual templates according to contractual requirements, In applying internal rules/instructions, records the Document translationand physical archiving. Prepares and participates in sub-system Gate Review and coordinates with the PrDM. Suggests improvements of the activity (REX on documentation issues: process, organisation) Performance measurements : Documentation Management KPIs (Quality, Delivery of in contractual documentation in due time) Perform overview about documentation milestones in general, Billing milestones, penalties Adherence to process, measured by process inspections Important to note As a global business, were an equal-opportunity employer that celebrates diversity across the 63 countries we operate in. Were committed to creating an inclusive workplace for everyone.

Job Title: Document Controller Location: Hyderabad Reports To: Project Manager / Planning Manager Job Summary: The Document Controller is responsible for the accurate and efficient management, tracking, and archiving of project and company documentation. They ensure that documents are correctly filed, version-controlled, and accessible to stakeholders, while maintaining confidentiality and compliance with company and regulatory standards. Key Responsibilities: Receive, register, review, and distribute incoming and outgoing project documents. Maintain an organized document filing system (physical and electronic). Ensure all documentation meets company formatting and quality standards. Track document revisions and ensure the latest versions are used. Coordinate with internal teams and external partners to manage document flow. Archive inactive documents according to document retention policies. Prepare document status reports for management and engineering. Control access permissions to documents and ensure data integrity. Assist in audits and quality checks related to document control. Implementation of new DMS system Requirements: Education: - High school diploma or equivalent (Bachelor's degree preferred). Experience: - 5-8+ years of experience in a similar document control or administrative role. - Experience in EPC company works in Petrochemical, Refinery, Chemicals, Fertilizers and O&G Skills: - Proficient in Microsoft Office (Word, Excel, Outlook). - Familiar with document control systems (e.g., Aconex, EDMS, SharePoint). - Strong attention to detail and organizational skills. - Good communication and teamwork skills. - Ability to handle confidential information. Preferred Qualifications : - Certification in document control or records management (optional but beneficial).

About Zeeco Zeeco designs and manufactures industrial combustion and pollution control technologies for the petroleum, chemical, petrochemical, and pharmaceutical industries. Zeeco product lines include ultra-low emission burners, gas and liquid flaring systems and hazardous waste incineration. Zeeco&aposs corporate headquarters covers over 230 acres (1 km2) near Tulsa, Oklahoma (USA) in a modern debt free facility and includes a 66,000 square-foot (6,132 m2) manufacturing facility and one of the industry&aposs largest combustion research and testing facilities. Zeeco subsidiaries reside in Houston Texas, USA, United Kingdom, South Korea, India, Saudi Arabia, and Japan. At Zeeco we openly challenge the status quo, find new way to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount would be based considering each candidate&aposs knowledge, skills, and abilities. Job Description We are seeking a detail-oriented and proactive Project Engineer to support project execution and documentation management across all phases of the project lifecycle. The ideal candidate will assist in coordinating with internal teams, suppliers, and external stakeholders to ensure seamless documentation flow, procurement support, and project communication. Job Responsibilities & Expectations Establish and maintain the Master Document Register in coordination with the Project Team. Communicate and liaise effectively with Project Teams, Suppliers, Third-Party Inspection Agencies, and the Client to ensure smooth documentation flow, project handover, and closure. Manage the complete document workflow electronically, ensuring traceability and accessibility. Ensure Document Management adheres to established procedures and standards, including document numbering, formatting, issuance, review, dispatch, recording, and archiving. Process incoming documentation such as Drawings, BOQs, Purchase Orders, and Invoices. Handle outgoing documentation and ensure proper distribution to respective stakeholders and departments. Maintain control and coordination of all project-related documentation; ensure that the latest approved versions are distributed and accessible both internally and externally. Ensure all drawings and documents are correctly identified, distributed, filed, and stored. Assist in the preparation, collation, and issuance of weekly/monthly reports. Monitor the review and approval process of technical documents in accordance with the document control index and project schedule. Track documentation progress and generate internal and external overdue reports as required. Set up project folders and facilitate effective project communication workflows. Provide support in Procurement Activities, including floating enquiries, receiving offers, generating bid tabulations, and creating purchase orders. Follow up on purchase order placements, manage sub-vendor documentation, and oversee approval processes. Handle Notifications of Inspection, Inspection Reports, and Release Notes. Assist in dispatch coordination and logistics for bought-out items. Support the preparation of project correspondence, minutes of meetings, and track action items effectively. Requirements Bachelors Degree in Engineering (Mechanical / Chemical). Minimum 5 to 8 years relevant experience in project engineering, document control, or project coordination, preferably in EPC, construction, or manufacturing sectors. Familiarity with engineering drawings, BOQs, technical specifications, and procurement documentation. Working knowledge of document control systems and software (e.g., EDMS, SharePoint, Aconex, or similar platforms). Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint); experience with MS Project or similar tools is a plus. Strong organizational and time-management skills with the ability to handle multiple priorities. Excellent communication and interpersonal skills, with a proactive and collaborative approach. Ability to work under minimal supervision and take initiative in resolving project issues. Exposure to procurement workflows, vendor coordination, and inspection documentation is desirable. Attention to detail and a commitment to maintaining high documentation standards. Ready to take your career to the next level This is your chance to work on impactful projects, collaborate with industry experts, and contribute to innovative engineering solutions. If youre driven, detail-oriented, and eager to grow in a fast-paced environment, wed love to connect with you. Join us and be part of a team where your skills make a real difference. Apply now and shape the future with us! Show more Show less

JOB DESCRIPTION Job Title: Assistant Manager Drug Substance QMS QA Job Location: Syngene Unit 3 Bangalore 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. 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 development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: Responsible for Drug Substance QMS QA Role To review and to carry out the assessment of Change control, Deviation, CAPA, OOS, OOT, Internal Audit, Market complaints & Product Recall To prepare QMS trends & QMS metrics, To conduct the Quality Review Meeting and coordination with CFT members. To prepare the QRM slides and presentation with site team members. Recording the Minutes of meeting. Knowledge in usage of Power BI tools & QMS data Graphical representation Handling of EQMS TrackWise Audit Management Handling of EDMS document management system pertaining to Biologics Operations Unit Preparation of trends as per schedule for all QMS elements as applicable To Perform the regulatory audits observations gap assessment To perform the revised guidelines gap assessment Follow-up and closure of all QMS elements as applicable Contribute to the review of audit reports and compliance reporting. Preparation of SOP / SOP-E / GP / Specifications / protocols / stan and relevant Annexure. Plan and schedule analytical activities in the department and ensure compliance with SQDECC parameters. Any other work allocated by HOD or team leader. Primarily responsible for the Quality Management System activities Responsible for the FDA 483 s and gap assessment review Responsible for cross deployment CAPA assessment Responsible for the Quality Review Meeting data presentation To review and approve the QMS events i. e. Change control, Deviation, CAPA, OOS & OOT To involve in the investigation of Drug Product related incidents & market complaints Involve in Monitoring of process through process step verification. Review of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions Involve in review and approval of documents related to CSV, LIMS, overall qualification activity, protocols, reports etc. Reporting any deviations and discrepancies to the superiors and reporting head. Handling of Deviations and its closure at right intervals Secondary label issuance for FG. Target Monitoring for batch related process activities Adherence to procedural systems, cGMP, data integrity & transparency maintained within the organization Equipment/Instrument Breakdown, Work Order approvals & tracking usage Return and verification approval of unused & excess materials Involve in Document Control and Document Issuance Involve in Archival of Documents. Role Accountabilities: Accountable for the above-assigned role Leadership Capabilities: Must have basic communication skills to interact with other cross functional dept. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 8-13 Years Demonstrated Capability: as per the above role Education: M. Pharm / M. Sc / Any Graduate Experience: 8-13 years Skills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in English Equal Opportunity Employer .

JOB DESCRIPTION Job Title: Junior Manager Analytical Quality Assurance Job Location: Syngene Unit 3 Bangalore 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. 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 development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: Responsible for Analytical Quality Assurance Role To review all analytical testing records related to Drug substance and Drug Product Experience with all types of QC instruments used for biological testing & drug product testing Responsible for QC instruments audit trail review in the laboratory Responsible for RM, PM, Consumables materials release in LIMS & SAP Responsible for inprocess test, finished product test, reports review and release in LIMS Responsible for review of specifications Responsible for Microbiology related testing review i. e. BET, Bioburden & Sterility test Responsible for OOS & OOT review in the trackwise To ensure the good documentation practices and ensure the data integrity compliance To review and to carry out the assessment of Change control, Deviation, CAPA, OOS, OOT, Internal Audit, Market complaints & Product Recall To prepare QMS trends & QMS metrics, To conduct the Quality Review Meeting and coordination with CFT members. To prepare the QRM slides and presentation with site team members. Knowledge in usage of Power BI tools & QMS data Graphical representation Handling of EQMS TrackWise Audit Management Handling of EDMS document management system pertaining to Biologics Operations Unit Preparation of trends as per schedule for all QMS elements as applicable To Perform the regulatory audits observations gap assessment To perform the revised guidelines gap assessment Follow-up and closure of all QMS elements as applicable Contribute to the review of audit reports and compliance reporting. Preparation of SOP / SOP-E / GP / Specifications / protocols / stan and relevant Annexure. Plan and schedule analytical activities in the department and ensure compliance with SQDECC parameters. Any other work allocated by HOD or team leader. Primarily responsible for the Quality Management System activities Responsible for the FDA 483 s and gap assessment review Responsible for cross deployment CAPA assessment Responsible for the Quality Review Meeting data presentation To review and approve the QMS events i. e. Change control, Deviation, CAPA, OOS & OOT To involve in the investigation of Drug Product related incidents & market complaints Involve in Monitoring of process through process step verification. Review of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions Involve in review and approval of documents related to CSV, LIMS, overall qualification activity, protocols, reports etc. Reporting any deviations and discrepancies to the superiors and reporting head. Handling of Deviations and its closure at right intervals Secondary label issuance for FG. Target Monitoring for batch related process activities Adherence to procedural systems, cGMP, data integrity & transparency maintained within the organization Equipment/Instrument Breakdown, Work Order approvals & tracking usage Return and verification approval of unused & excess materials Involve in Document Control and Document Issuance Involve in Archival of Documents. Role Accountabilities: Accountable for the above-assigned role Leadership Capabilities: Must have basic communication skills to interact with other cross functional dept. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 8-13 Years Demonstrated Capability: as per the above role Education: M. Pharm / M. Sc / Any Graduate Experience: 8-13 years Skills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in English Equal Opportunity Employer .

Candidate having below qualifications is considered for this role: IFRS Knowledge SAP system experience The position requires a degree of flexibility in working hours when meeting strict month-end timings and deadlines Precision and have an eye for detail The candidate should have a core Accounting Acumen. A high degree of PC literacy, including knowledge of Excel & PeopleSoft. Excellent verbal and written communication skills Able to communicate effectively at all levels Effective time management and prioritisation skills, with ability to deliver within deadlines To understand what the fair treatment of customers means and to ensure this is consistently incorporated into the role as appropriate. Portray high level of Integrity at work and have a learning dynamic mindset Daily: Perform Daily JVs and ensure Daily Journals are posted into SAP. Review the daily Checklist and ensure all activities are completed Daily review of Generic-id emails and respond within 24 Hrs. Monthly: Download month-end Reports from respective systems. Month-end journals are posted as per Standard list in SAP Upload all posted JVs into EDMS Manual Sub-ledger preparation Review and Update the Desk Procedures as when changes are required Prepare the monthly metrics Annually: Participate in Audit process walkthroughs, support GAO audits. Ensure all procedures are reviewed at least annually Support MCRP design and testing, including spreadsheet control tasks General - Ongoing Maintain Business Continuity Plan. Review Finance Manual changes and consider impact on the team s responsibilities. Ad-hoc projects as required