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3.0 - 7.0 years
0 Lacs
karnataka
On-site
As an Engineering Document Control Specialist at our Bangalore office, you will play a crucial role in maintaining and supporting changes to controlled documents with precision and attention to detail. Your responsibilities will include processing Engineering Change Orders (ECOs) in our Agile Product Lifecycle Management (PLM) system and managing Oracle ERP item attribute maintenance. Collaboration with cross-functional teams and generating reports to identify areas for improvement will be key aspects of your role. Additionally, providing training and support to users on document control procedures and systems will be an essential part of your responsibilities. You will need to have a Bachelor's degree in Engineering or a related field, along with strong organizational skills and the ability to manage multiple tasks effectively. Experience in document control processes and systems, particularly in regulated industries like Semiconductors or Core Engineering, will be advantageous. Proficiency in using PLM systems such as Agile PLM and ERP systems like Oracle ERP is preferred. Excellent communication skills and the ability to work collaboratively in a team setting are essential for success in this role. You should also be comfortable adapting to changing priorities and deadlines in a fast-paced environment. Experience with reading Engineering Prints and Bills of Materials, as well as understanding Bill of Material structure and revision control across documents and design files, will be beneficial. Familiarity with electro-mechanical devices and general manufacturing processes is also desirable. If you are passionate about document control and eager to contribute your expertise to a dynamic team environment, we invite you to apply for this exciting opportunity.,
Posted 1 day ago
4.0 - 8.0 years
0 Lacs
chennai, tamil nadu
On-site
The opportunity: The Hitachi Energy India Operations Center (INOPC) houses over 3,000 energy transition technologists in three locations from grid automation, transformers, high voltage products, grid integration and service businesses. Spread over 3,00,000 sq feet, with nearly 50,000 sq feet of dedicated lab space, the center brings under one roof diverse engineering capability that has been built over the years, fostering collaboration to advance the worlds energy system to be more sustainable, flexible and secure. INOPC supports Hitachi Energy units across 40+ countries to deliver projects in 80+ countries. We are technology leaders at the forefront of evolving the worlds future energy system. The rising energy consumption with changing lifestyles and rapid urbanization, is driving the need for affordable, reliable and sustainable energy. Our innovative technologies help to make the energy system more resilient, secure and safe. How you'll make an impact: - Review of document requirements as per project specifications and customer requirements during project handover from sales. - Develop and maintain a document control master list for every project, align with internal stakeholders and customer representatives. - Drive the completion, submission, and approval of key documents and keep track of every document transaction (through transmittals). - Understand and manage client EDMS system. - Coordinate and follow-up for all project-related drawings and other key document submissions/approvals and maintain an updated status of drawings and documents in the master file. - Prepare the documentation for customer submission and keep a track record of customer correspondence. - Keep project manager updated regularly on the document status during project reviews. - Participate in document approval status review meetings. - Act as the main contact for customers in projects for documentation-related topics. Support the Project Manager for drafting and submission of contractual letters to the customer. - Perform archiving/scanning/printing - including renaming, recording, and filing incoming hard or electronic copies of drawings & documents (Internal and External). - Ensure all management system documentation is the current version and easily accessible in hard files/digital records. - Develop/maintain document control processes for efficient project management. - Prepare documentation for Production handover and I&C handover. - Responsible to ensure compliance with applicable external and internal regulations, procedures, and guidelines. - Live Hitachi Energy's core values of safety and integrity, which means taking responsibility for your actions while caring for your colleagues and the business. Your background: - Bachelor of Science, with document control experience of at least 4 years. - Must have working experience in project execution similar projects and a minimum of 2 years leading and coordinating with external customers. - Good interpersonal skills and ability to communicate effectively with all project stakeholders. - Ability to work on multiple projects and deliver quality results on time. - Good working knowledge of MS Office (Word, Excel, PowerPoint, SharePoint, etc.) and at least one type of document control system. 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. This is solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.,
Posted 1 day ago
0.0 - 4.0 years
0 Lacs
chennai, tamil nadu
On-site
You will be responsible for managing and maintaining all company documentation, ensuring accuracy, up-to-date information, and easy accessibility. You will oversee the distribution of documents, ensuring relevant staff have appropriate access while maintaining confidentiality and security protocols. Developing and implementing documentation policies and procedures will be a key aspect of your role. Additionally, you will review and update technical documents as required and provide document control support to various departments. Training staff on documentation control procedures and best practices will also be part of your responsibilities. This is a Full-time, Permanent position suitable for Fresher candidates. The job offers benefits such as Provident Fund and a Performance bonus. The work schedule includes Day shift, Fixed shift, and Morning shift. The work location is on-site. If you are detail-oriented, organized, and have a strong understanding of document management, this role could be a great fit for you.,
Posted 1 day ago
2.0 - 6.0 years
0 Lacs
faridabad, haryana
On-site
VES is currently seeking a Draftsperson to join the team in Faridabad, India. As a Draftsperson, your primary responsibility will be to assist in engineering design drafting and the creation of technical documents. Your essential duties and responsibilities will include assisting in the creation of technical documents, supporting engineering design drafting, technical projects, and product development. You will also be involved in various technical tasks such as deviation/concession requests, managing the Product Design Request system, creating and checking engineering drawings for variations of existing products, and maintaining document control. Additionally, you will have the opportunity to provide input in engineering meetings and reports. To qualify for this position, you should have an ITI/Diploma in Mechanical Engineering with at least 2 years of experience in Solidworks and design office. Strong relationship skills, an organized, and disciplined approach are essential for success in this role. Thank you for considering a career with Varel Energy Solutions. We look forward to potentially welcoming you to our team. Powered by JazzHR,
Posted 2 days ago
2.0 - 6.0 years
0 Lacs
noida, uttar pradesh
On-site
As an IT Project Manager at our company, you will play a vital role in overseeing project teams and ensuring the timely completion of IT projects. Your primary responsibility will involve establishing a Project Management Office (PMO) to streamline project operations and effectively utilize resources across different project divisions to achieve set targets. It will be your duty to maintain compliance with project budgets and other specified requirements. Additionally, you will be responsible for documenting instructions for end-users, facilitating product testing, engaging with stakeholders at all project stages, and efficiently closing projects. Your key responsibilities as an IT Project Manager will include: - Assisting in the establishment of a Project Management Office to supervise multiple projects. - Collaborating with stakeholders, including project team members, vendors, and end-users, to understand project needs. - Defining project scopes, goals, and kickstarting project activities. - Implementing document control processes and utilizing documentation templates. - Maintaining a comprehensive understanding of individual project components. - Assessing the quality standards of project deliverables. - Monitoring project advancement and making necessary adjustments when required. - Tracking project expenses in alignment with the allocated budget. - Ensuring adherence to project objectives, organizational policies, procedures, and quality standards. - Compiling and presenting project reports to management, highlighting any issues. - Enforcing compliance with best practices, standard operating procedures (SOPs), PMO policies, and other relevant guidelines. To be considered for this role, you should possess the following qualifications: - A minimum of 2 years of experience in a project management capacity. - Proficiency in MSP ticketing and Alert Management Systems. - Sound knowledge of project management principles and practices. - Familiarity with the software development life cycle. - Exceptional leadership, organizational, and time management abilities. - Excellent verbal and written communication skills. - Strong interpersonal skills. This is a full-time position with benefits including health insurance, leave encashment, and provident fund. The work schedule is during day shifts, and applicants should be willing to commute or relocate to Noida, Uttar Pradesh.,
Posted 3 days ago
2.0 - 6.0 years
5 - 9 Lacs
Pune
Work from Office
A Snapshot of Your Day Document Controller responsibilities include typing contracts, archiving files, and ensuring all team members have access to necessary documentation To be successful in this role, you should have previous experience reviewing technical documents along with the ability to spot errors, Ultimately, document controller supports our procedures maintaining clear, up-to-date and easily traceable documents, How Youll Make An Impact 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 Build 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 What You Bring Graduate in any field Preferably 3 to 5 years minimum meaningful experience of Document controller Familiarity with project management Experienced in managing/coordinating projects remotely in a globally distributed setup Basic knowledge of labor and corporate law Also, knowledge of Industrial Financial Services (IFS), DocPoint, SharePoint, AutoCAD 2010, GloBus Teamcenter will be added advantage Hands-on experience with MS Office and MS Excel Experience with Document Management software's like Relatics, SharePoint, Aconex, or Documentum, Web based software Knowledge of Electronic Document Management Systems (EDMS) Proficient typing and editing skills Competency in standard office computer programs including the Microsoft Office Suite (Office 365), Adobe Acrobat, WinZip, Volo View, Web-based Client Portals, About The Team Our Transformation of Industry division is decarbonizing the industrial sector Growing electrification and efficiency are key and demand for green H2 and derivative fuels will rise We enable decarbonization of the industrial sector and the transition to sustainable processes, building on a strong industrial customer base, a global network, diverse technologies, and integrated execution capabilities Candidates want to learn about the divisions they will be joiningthe structure, how it works together, and the role it plays in driving Siemens Energys mission forward, Who is Siemens Energy At Siemens Energy, we are more than just an energy technology company With ~100,000 dedicated employees in more than 90 countries, we develop the energy systems of the future, ensuring that the growing energy demand of the global community is met reliably and sustainably The technologies created in our research departments and factories drive the energy transition and provide the base for one sixth of the world's electricity generation, Our distributed team is committed to making sustainable, reliable, and affordable energy a reality by pushing the boundaries of what is possible We uphold a 150-year legacy of innovation that encourages our search for people who will support our focus on decarbonization, new technologies, and energy transformation, Find out how you can make a difference at Siemens Energy: https:// siemens-energy /employeevideo Our Commitment to Diversity Lucky for us, we are not all the same Through diversity, we generate power We run on inclusion and our combined creative energy is fueled by over 130 nationalities Siemens Energy celebrates character no matter what ethnic background, gender, age, religion, identity, or disability We energize society, all of society, and we do not discriminate based on our differences, Rewards/Benefits All employees are automatically covered under the Medical Insurance Company paid considerable Family floater cover covering employee, spouse and 2 dependent children up to 25 years of age, Siemens Energy provides an option to opt for Meal Card to all its employees which will be as per the terms and conditions prescribed in the company policy as a part of CTC, tax saving measure Flexi Pay empowers employees with the choice to customize the amount in some of the salary components within a defined range thereby optimizing the tax benefits Accordingly, each employee is empowered to decide on the best Possible net income out of the same fixed individual base pay on a monthly basis https://jobs siemens-energy /jobs Show
Posted 3 days ago
5.0 - 10.0 years
25 - 27 Lacs
Mumbai
Work from Office
We believe real value is powered by the unique skills and experiences of our professionals. The interchange of ideas from a diverse group of people gives our teams an expanded perspective and the ability to find better solutions for our clients. Req Id : 109842 Job Title : Lead Offshore Structural Engineer Business Unit sector : CPL-BVOPS-ENGR & DEV SVCS Department: BVCPL BV OPS EDS STRUCTURAL/AR Work Location : INMUMBAI2 Opportunity Type : Staff Relocation eligible : Yes Full time/Part time : Full-Time Contract Hire Only for this Project : No Visa Sponsorship Available: No Recruiter : Indranee Bindu Job Summary Functions in a lead engineering technician capacity. Under general direction, modify or create deliverables and may perform assignments of a design nature by applying basic engineering principles and established design practices to develop moderately complex design concepts. Provide technical guidance and may provide direction to other engineering professionals. Key Responsibilities Engineering Standards: Applies knowledge of standards, systems, document control, departmental guides, applicable codes and Black and Veatch policies and procedures May review project requirements and accurately determine the correct format and contents of the required deliverables Quality / Continuous Improvement: Proactively applies Black and Veatch Quality Program to deliverables Demonstrates personal accuracy and supports continuous improvement and change management efforts Reviews design inputs in order to ensure consistency Assists to ensure deliverables are in compliance with the specific codes and standards suitable for the project Engineering Production: May apply basic engineering principles and established design practices in developing moderately complex design concepts and deliverables Begins to apply judgment and make decisions with respect to deliverables and input interpretation Capable of handling difficult technical assignments within an area of expertise and can provide technical guidance to other professionals Performs design calculations, detailed material quantities and estimates, and records May review the deliverables of others May define work assignments and maintain schedules May program control systems or participate in other plant start-up activities associated with a specialized area of expertise Project Coordination: Coordinates with other design group personnel to review and exchange project information necessary for design development May support field activities Client Focus: Focuses on the needs of internal clients while utilizing an understanding of external clients main interests and drivers Knowledge Sharing, Innovation and Technology: Proactively seeks and shares knowledge of latest technologies and processes May apply judgment and makes decisions with respect to deliverables and input interpretation People Management - (supervision - career development - developing professionals, mentoring): May assist with performance management process, mentoring, and recognition Provide guidance to lesser experienced Engineering technicians May provide mentoring, instruction, delegation of work and feedback Management Responsibilities Preferred Qualifications Diploma or Certificate preferred Associate Degree in Drafting or an Engineering Design Related Technology preferred Typically a minimum of 5 years related work experience Preferred Non-Technical Skills: Learning on the Fly Problem Solving Perseverance Patience Time Management Drive for Results Self Development Listening Informing Preferred Technical Skills: Experience in the appropriate electronic applications and programs required for performing assignments to include but not limited to CADD or other electronic applications . Intermediate knowledge of engineering standards, systems, document control, departmental guides and Black and Veatch policies and procedures Intermediate industry knowledge and technology trends Intermediate knowledge of company quality program Advanced ability to interpret engineering deliverable content as assigned Intermediate knowledge of other disciplines Basic knowledge of construction and constructability practices and principles Basic knowledge of engineering design principles and applicable design guides related to assigned engineering discipline Basic knowledge of procurement and contract administration Minimum Qualifications All applicants must be able to complete pre-employment onboarding requirements (if selected) which may include any/all of the following: criminal/civil background check, drug screen, and motor vehicle records search, in compliance with any applicable laws and regulations. Certifications Work Environment/Physical Demands Normal office environment Competencies Customer focus Salary Plan ENT: Engineering Technician Job Grade 129 BVH, Inc., its subsidiaries and its affiliated companies, complies with all Equal Employment Opportunity (EEO) affirmative action laws and regulations. Black & Veatch does not discriminate on the basis of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender Identity and expression, disability, veteran status, pregnancy status or other status protected by law. By valuing diverse voices and perspectives, we cultivate an authentically inclusive environment for professionals and are able to provide innovative and effective solutions for clients.
Posted 3 days ago
3.0 - 10.0 years
1 - 5 Lacs
Mumbai
Work from Office
To support the setup and execution of qualityassurance processes across the fabrication lifecycle, including release checks,WPS traceability, documentation control, and audit preparedness enablingright-first-time fabrication, weld traceability, and ISO/client compliance. Key Responsibilities 1. Assist the QA Lead in preparing and maintainingfabrication ITPs (Inspection and Test Plans), release checklists, and drawingcontrol logs. 2. Verify that jobs are released for fabrication only after drawings, WPS, revision numbers, and material traceability are availableand correct. 3. Maintain welder qualification logs, welding procedurerecords (WPS/PQR), and consumable usage logs per QA formats. 4. Support part tagging, kit bundling, and job foldercreation to ensure traceability of parts and assemblies across sections. 5. Help organize QA documentation per project: ITPs, weldmaps, NCRs, calibration certificates, PMI (positive material identification) reports,inspection handovers, etc. 6. Coordinate with the QC team to ensure inspectiondocuments are received and properly filed for each job. 7. Participate in root cause analysis (RCA) of repeatdefects or NCRs support updating SOPs and training documents accordingly. 8. Assist in preparing for ISO/client audits by ensuringQA folders are complete, up-to-date, and logically arranged. 9. Ensure controlled formats and document versions areused in all departments escalate unauthorized formats or outdated versions. 10. Coordinatewith Design Detailing to track drawing revisions and ensure versioncontrol is implemented across jobs. Qualifications Experience Diploma / B.Tech in Mechanical / Industrial /Production / Metallurgy Engineering 13 years experience in QA documentation orfabrication project QA support Familiarity with ITPs, SOPs, and documentationcontrol in a quality-driven setup Basic knowledge of WPS/PQR, revision tracking, traceability, and part numbering Good Excel/documentation skills and attention torecord accuracy Preferred: Exposure to ISO 9001 audits or fabrication traceability systems Good coordination and follow-up skills acrossdepartments and shifts
Posted 3 days ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled documents, regulations, guidelines, and client agreements. - Serving as a control point for SOPs/controlled documents and Quality Management System documents. - Contributing to the creation of controlled documents such as SOPs and Work Instructions. - Supporting the internal quality program including quality assurance and quality control. - Assisting in investigating service complaints and deviations, identifying root cause and CAPAs, and communicating these to the Managers. - Collaborating with Operational and Client Services Managers to support preparation for client audits and regulatory inspections. - Hosting client audits and regulatory inspections at ProPharma Group and acting as an SME for quality topics. - Developing responses to CAPAs arising from client audits and regulatory inspections, with support from Operations Managers, Client Services, and Global Quality, and tracking to completion and closure. - Participating in relevant client operational meetings as directed by Management. - Supporting the Quality Manager in the Regional Quality Committee and acting as a regional representative in the Global Quality Committee. - Proactively identifying improvement opportunities to support the development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. - Identifying any issues that could potentially impact services and escalating areas of concern within the business to Management, with potential corrective actions. - Other responsibilities as assigned. Necessary Skills & Abilities: - Excellent attention to detail and focus on quality. - Strong verbal and written communication skills. - Excellent workload management skills. - Ability to prioritize workload and meet deadlines. - Excellent questioning and listening skills. - Capable of resolving conflict constructively. - Able to collaborate with colleagues in other departments effectively. - Ability to speak effectively in interpersonal situations and presentations. - Possesses a service-oriented approach. - Flexible and proactive toward changing needs. - Good understanding of quality assurance regulations and guidelines, preferably related to cGxP. - Quality Assurance experience in internal and external audits, maintaining regulated documents, and training files, preferably related to cGxP. - Knowledge of FDA regulations for adverse event and product complaint reporting. - Proficiency in MS Word, Excel, and PowerPoint. Educational Requirements: - University/Bachelor's degree and/or appropriate relevant work experience. Experience Required: - 5 years Quality experience in pharmaceutical or medical device industries or other regulated industry. - Previous experience in data mining, analysis, and presentation. - Previous audit experience preferred. ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves and are encouraged to be innovative and collaborative. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Please note that ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Phone calls or emails regarding this posting are not accepted.,
Posted 3 days ago
15.0 - 19.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancements to achieve the desired levels of quality. You will lead and oversee the quality teams across all manufacturing facilities, focusing on continuous improvement initiatives. Team building will be a key aspect of your role, where you will be involved in establishing, inspiring, training, mentoring, and managing a team of QA professionals to adapt to new processes and tools effectively. Collaboration with business units to set quality targets for new and existing products, managing quality projects resulting from site consolidations or acquisitions, and working with the Quality Management System group to streamline and harmonize quality systems will also be part of your responsibilities. You will be responsible for maintaining the effectiveness of the Quality System across all Shalina manufacturing sites and Contract Manufacturing site, as well as implementing and monitoring an effective Vendor/Supplier development process. You will lead recruitment activities, ensure the professional development of direct reports and the overall company quality organization, and establish standards and metrics to support exponential growth while adhering to quality standards and regulatory guidelines. Additionally, your role will involve participating in various functional meetings, such as Supply Chain, Operational Excellence, and Sourcing, R&D. Your essential qualifications and experience include a degree in M.Pharm/B.Pharm/Master's in science, along with 15+ years of leadership experience in quality assurance, preferably in the pharmaceutical or life sciences industry. You should possess a strong understanding of ROW regulatory landscapes and international quality standards, exceptional commercial acumen, strategic business insight, and excellent consulting and communication skills to influence senior stakeholders effectively. Moreover, you should demonstrate personal credibility, strong interpersonal skills, integrity, dependability, and a results-oriented approach. Experience in working cross-culturally and cross-functionally with diverse colleagues is essential for this role. Your responsibilities will also include providing training efforts at Shalina sites as needed, advising and supporting alliance partners/service providers/central distribution center to ensure compliance with quality requirements, and offering immediate support during audits and compliance checks. In summary, as the Head of Corporate Quality, you will lead the development and execution of quality assurance strategies aligned with the company's goals, ensuring regulatory compliance, continuous improvement, and effective quality management systems across manufacturing facilities. Your role will involve team building, collaboration with business units, and maintaining compliance with global quality standards while supporting growth and customer satisfaction.,
Posted 3 days ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
The Quality Engineer plays a crucial role within the Quality department, serving as a functional expert for the Change Management process. This position requires in-depth knowledge of CAPA, NC, and Investigations, as well as proficiency in the change control process. One of the key responsibilities is to address and resolve issues related to Change and Documentation Modules on SmartSolve. In addition, the Quality Engineer collaborates with the Master Data Team to resolve issues in SAP for the ECO notifications. It is essential to maintain procedures for Document Control and Change Control processes while ensuring compliance with the established Change Management process. Timely review of approvals and implementation of updates is vital to support the various business units effectively. Apart from the primary skill set, the role also demands proficiency in Microsoft Office, drawing packages such as CAD, and familiarity with ERP systems, preferably SmartSolve and SAP. The ideal candidate should possess exceptional organizational skills with the ability to prioritize tasks efficiently. Strong interpersonal skills are also a key requirement for effective communication and collaboration within the team.,
Posted 4 days ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Dear Candidate, We are hiring the Position of Project Billing Document Controller for Drillmec International Pvt Ltd (MEIL Group) Job Responsibilities: • Keep an accurate record of client accounts and outstanding balances • Send invoices and account updates to clients electronically and on paper • Update our system with payment information and other financial data • Suggest payment assistance programs for clients in need • Notify clients of upcoming or missed payment deadlines • Receive, sort, and track incoming payments • Issue receipts for payments received • Address our clients' billing questions and issues • Prepare reports and review billing activity for accuracy • Uphold our strict client confidentiality policies Interested and suitable candidates can share below details and your updated CVs by Mentioning subject of "Document Controller" to careers@drillmecinternational.com / snaveenkumar@drillmecinternational.com Candidate Name : Qualification : Stream : Current Employer : Designation : Work Exp : Current CTC : Expected CTC : Notice Period : Current Location : Native :
Posted 4 days ago
6.0 - 8.0 years
8 - 10 Lacs
Visakhapatnam
Work from Office
Qualification: B.Tech / M.Sc. in Life Sciences, Biomedical Sciences, or a related postgraduate degree Job Summary: We are seeking a highly skilled and experienced Quality Assurance (QA) professional to serve as Assistant Manager for QA operations supporting IVD manufacturing and compliance activities at Labsystems Diagnostics Oy . This role will lead Change Control processes , assist in ISO 13485 QMS audits , and support a range of quality system functions , including CAPA, document control, training, and cross-functional quality initiatives. The ideal candidate will have strong domain expertise in IVD and be confident in supporting both internal quality improvement and external regulatory expectations , including IVDR compliance. Key Responsibilities: Manage and lead the Change Control system , ensuring accurate documentation, timely follow-up, and cross-functional impact assessment. Support internal and external audits , including ISO 13485, Notified Body (NB), and customer audits. Drive CAPA processes , root cause analysis, effectiveness checks, and preventive actions. Collaborate with cross-functional teams (RA, R&D, Manufacturing, Service) to maintain and improve QMS effectiveness and regulatory compliance. Assist in preparation, review, and maintenance of SOPs , Quality Plans , Risk Management files , and Technical Documentation . Monitor QMS metrics and generate quality performance reports for management review. Ensure Document Control procedures are followed for all quality and regulatory documents. Support training coordination , maintaining training matrices and ensuring compliance with competency requirements. Contribute to supplier quality oversight , including evaluation, qualification, and performance monitoring. Assist in IVDR transition activities , particularly in areas impacting QA documentation and audit readiness. Required Skills & Experience: 6-8 years of hands-on experience in Quality Assurance in the IVD or medical device industry . Strong knowledge of ISO 13485:2016 , with practical experience in managing QMS elements such as Change Control, CAPA, and Document Control. Demonstrated experience in audit preparation, participation, and follow-up for regulatory and certification audits. Familiarity with risk-based approaches , complaint handling inputs, and quality planning. Excellent communication, documentation, and problem-solving skills. High level of ownership, attention to detail, and continuous improvement mindset.
Posted 4 days ago
2.0 - 3.0 years
5 - 9 Lacs
Ahmedabad
Work from Office
Responsible for handling, organizing, and distributing, all project documents, including but not limited to drawings, contracts, specifications, and other correspondence related to project Ensures that all documents are accurately recorded, sorted, filed electronically and physically(if needed), and distributed to the appropriate internal & external parties Maintaining document control systems, tracking revisions and updates, and ensuring compliance with company, client, and industry standards Supports Project Managers with retrieval of documentation requirements Provide direct assistance coordinating document reviews, handling document approval processes, and providing support during audits and inspections Overall, the document controller plays a crucial role in maintaining the integrity and organization of project documentation throughout the project life cycle, Responsibilities Document controller plays a crucial role in managing and organizing documents within an organization Their primary responsibility is to ensure that documents are properly created, reviewed, approved, and archived in accordance with organizational procedures and industry standards Here are the key tasks and responsibilities of a Document Controller: Document Creation and Formatting: Create templates for various types of documents, Ensure that documents adhere to the organization's formatting and styling guidelines Inline with the client's requirement as well, Verify that all necessary information is included in the documents, Document Review and Approval: Ensure documents are sorted correctly and distributed to relevant stakeholders for review, Track and follow up on the status of document review and approval, Ensure review documents are uploaded on relevant portals, Document Distribution: Distribute approved documents to the respective individuals or departments, Ensure that the correct versions of documents are circulated, Version Control: Maintain a version control system for documents to track changes and updates, Clearly label and document revisions to avoid confusion, Document Retrieval and Archiving: Establish and maintain an organized document filing and retrieval system, Archive obsolete or outdated documents according to the organization's retention policies, Quality Assurance: Conduct regular quality checks on documents to ensure accuracy and completeness, Work with relevant departments to address any discrepancies or issues, Communication: Facilitate communication between different departments regarding document-related matters, Respond to inquiries related to document status, location, or other relevant information, Continuous Improvement: Find opportunities for process improvement within the document control system, Implement best practices to enhance the efficiency and effectiveness of document control processes, Software and Tools: Apply document management software and tools to streamline processes, Stay updated on advancements in document control technology, Training and Awareness: Provide training to staff on document control procedures and policies, Foster awareness of the importance of document control within the organization, Self-motivated, Communicate efficiently to avoid ambiguity, Build good relationships and work well within a multi-disciplined team, Ability to build engineering concepts from scratch, Learn about new products and adapt new ideas quickly and accurately, Proficient in both written and spoken English, See challenges as opportunities About Ideal Candidate Excellent communication skills (English language); oral & written Proficient typing and editing skills communication and interpersonal skills attention to detail analytical and problem-solving ability planning skills persistence and the ability to influence others a strategic approach to work ability to facilitate change skills in numerical and statistical analysis an understanding and appreciation of other people's work fields, such as engineering and science, Educational Qualification & Work Experience BSc degree in Project Management or relevant field 2-3 yearsshown experience working in a Document Controller/ Project Administration position coming from an engineering/construction environment, Familiar with Quality Standards/Document Control Procedures a must Familiar with project management a must
Posted 4 days ago
4.0 - 8.0 years
0 Lacs
surendranagar, gujarat
On-site
As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,
Posted 5 days ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Document Controller at Trelleborg, you will be responsible for handling, organizing, and distributing all project documents, such as drawings, contracts, specifications, and correspondence related to the project. Your role will involve accurately recording, sorting, filing both electronically and physically, and distributing documents to the appropriate internal and external parties. You will be maintaining document control systems, tracking revisions and updates, and ensuring compliance with company, client, and industry standards. Your support to Project Managers will include retrieving documentation requirements, coordinating document reviews, handling approval processes, and providing assistance during audits and inspections. Overall, your contribution will be vital in maintaining the integrity and organization of project documentation throughout the project life cycle. As a Document Controller, your primary responsibility is to manage and organize documents within the organization, ensuring that they are created, reviewed, approved, and archived in accordance with organizational procedures and industry standards. Your key tasks and responsibilities will include creating templates, developing quality standards, preparing Inspection and Test Plans (ITPs), inspecting reports, tabulating data, formatting documents, reviewing and approving documents, distributing approved documents, maintaining version control, establishing a document filing and retrieval system, conducting quality checks, facilitating communication between departments, identifying process improvement opportunities, providing training, and staying updated on document management technology. The ideal candidate for this role should possess excellent communication skills in English, both oral and written, proficient typing and editing skills, attention to detail, analytical and problem-solving ability, planning skills, persistence, strategic work approach, change facilitation ability, numerical and statistical analysis skills, and an understanding of engineering and science fields. The educational qualifications required are either a Diploma in Mechanical Engineering with 5+ years of experience in a similar role, a University Bachelor's Degree in Mechanical or Production Engineering with 3+ years of experience in a similar role, or 5+ years of experience in a similar role. Familiarity with Quality Standards/Document Control Procedures and project/document management is a must, along with proficiency in English communication. Trelleborg is an equal opportunity employer that values diversity and is dedicated to creating an inclusive environment for all employees. Accommodations will be provided for individuals with disabilities during the job application or interview process, job functions, and other employment benefits and privileges upon request. Join us at Trelleborg and be a part of #shapingindustryfromtheinside. Apply now to seize this opportunity without delay!,
Posted 5 days ago
0.0 - 1.0 years
0 - 2 Lacs
Ahmedabad
Work from Office
We seek a detail-oriented fresher to join our QC Lab as a Documentation Executive. Responsibilities include managing QC documents, data entry, and ensuring compliance with quality standards and regulations in a food color manufacturing setup.
Posted 6 days ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
The role of Quality Control Manager in Critical Care Business at Bethlehem, PA involves overseeing all Quality Control functions to ensure alignment with core values and ethical practices. Your primary responsibility is to ensure that the Quality Control department meets the needs of both internal and external customers by delivering services and products on time. You will collaborate with various internal stakeholders such as API Manufacturing, Packaging, Quality Assurance, Engineering, Regulatory Affairs, EHS, Supply Chain and Logistics, as well as external stakeholders including Auditors, Customers, Regulatory Agencies, and External Suppliers. Reporting directly to the Senior Manager of Quality Control, your essential duties and responsibilities include leading a team of QC Analysts, ensuring compliance with quality systems and regulatory requirements, maintaining documentation, coordinating investigations and improvement projects, reviewing and approving test documents, managing quality processes through SAP system, overseeing batch production and testing, participating in product development support, and maintaining lab equipment. To be successful in this role, you must possess strong organizational and communication skills, critical thinking abilities, excellent customer service skills, creativity in problem-solving, energetic and motivational disposition, confidentiality maintenance, coaching skills, proficiency in computer tools, and the ability to lead a team in a fast-paced environment while managing multiple projects effectively. The ideal candidate should have a B.S. in Chemistry or a related discipline, minimum 5 years of experience in a pharmaceutical manufacturing laboratory environment, at least 3 years of supervisory experience, hands-on experience with quality systems in a GxP environment, familiarity with FDA, MHRA, and other health authority inspections, knowledge of international regulations, and audit experience. If you are looking for a challenging opportunity in Quality Control with a focus on pharmaceutical manufacturing, this role at 3950 Schelden Circle, Bethlehem, PA, 18017, US might be the perfect fit for you.,
Posted 6 days ago
2.0 - 8.0 years
0 Lacs
maharashtra
On-site
You will be responsible for preparing, reviewing, and implementing Standard Operating Procedures of Quality Assurance, ensuring that day-to-day QA Controls are in place, and empowering QA for the entire plant. Your role will involve establishing, implementing, and maintaining the necessary processes for the Quality management system. You will adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. Issuance of Quality Management System related formats and maintaining the log accordingly will be under your purview. You will be required to follow up on deviations, change controls, incidents, material and product destructions, Internal Audits, re-packing activities, and corrective & preventive actions with the respective departments. As part of your responsibilities, you will prepare risk assessment documents and ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. It will be your duty to maintain documents as per current Good Manufacturing Practices and to intervene and call meetings to resolve QMS and GMP related queries. You will provide documents for regulatory affairs and handle regulatory queries. Co-ordination with internal department personnel as well as external parties will be essential. Additionally, you will be responsible for audit preparation, execution, and compliance, as well as handling notifications to management regarding documents. Investigating and reviewing non-conforming events, including customer complaints and internal non-conforming events, and deciding on Corrective and Preventive Actions (CAPA) will be part of your role. You will prepare, review, and implement the Master list of Standard Operating Procedures and review qualification and validation documents. Reviewing and implementing the Annual Training Plan of GMP/Technical/SOP training, coordinating with the concerned departments for execution, and maintaining training records will be crucial. You will also be responsible for verifying and implementing the Batch Numbering system and allocating Equipment identification numbers, as well as reviewing and following up on the updating of equipment/instrument lists. Managing the update/review of the approved vendor list, vendor qualification planning, and documents will also fall within your responsibilities.,
Posted 6 days ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
As an Engineering Document Control Specialist at our Bangalore office, you will play a crucial role in maintaining and supporting changes to controlled documents while ensuring accuracy, compliance, and efficiency in our document management processes. Your responsibilities will include processing Engineering Change Orders (ECOs) in our Agile Product Lifecycle Management (PLM) system and managing Oracle ERP item attribute maintenance. You will collaborate with cross-functional teams to ensure effective communication and coordination of document control activities. Your key responsibilities will involve maintaining and supporting changes to controlled documents, processing Engineering Change Orders (ECOs) in the Agile PLM and Priority systems, performing Oracle ERP item attribute maintenance, collaborating with cross-functional teams, generating reports and metrics related to document control processes, and providing training and support to users on document control procedures and systems. To excel in this role, you should possess a Bachelor's degree in Engineering or a related field, strong attention to detail and organizational skills, experience with document control processes and systems in a regulated industry, proficiency in using PLM and ERP systems, excellent communication and interpersonal skills, the ability to work collaboratively in a team environment, adaptability to changing priorities and deadlines, and experience with reading Engineering Prints and Bills of Materials. If you are passionate about document control and eager to contribute to a dynamic team environment, we encourage you to apply for this exciting opportunity. Please note that certain positions may require access to controlled goods and technologies subject to specific regulations, and applicants for these positions may need to be U.S. persons as defined by law. At MKS, we are committed to diversity and inclusion, and we provide reasonable accommodations to qualified individuals with disabilities. If you require a reasonable accommodation during the application or interview process, please reach out to us at accommodationsatMKS@mksinst.com.,
Posted 1 week ago
0.0 - 2.0 years
1 - 2 Lacs
Chennai
Work from Office
Must have strong computer and document management skills, good communication, and willingness to call candidates/agents repeatedly. Should be disciplined, organized, responsible, self-initiated, and accessible 24x7
Posted 1 week ago
2.0 - 7.0 years
4 - 9 Lacs
Bengaluru
Work from Office
About Company: H&MV Engineering is a trusted name in the electric power transmission industry. Established in 1997, we have quickly become a leading specialist in high voltage Transmission and Distribution systems. Our leading position in the market allows us to expand our services worldwide we re currently present in EU, UK, Asia and South Africa, exploring further possibilities to expand and finding ways to leverage the experience we gain internationally. Our main expertise is in the design and build of substations up to 420 kV. We have successfully completed projects across many sectors Transmission and Distribution, Renewables, Data Centres, Manufacturing and Pharmaceuticals, to name a few. H&MV is currently seeking a Document Controller to join their busy Limerick office to help support Projects and Project Teams. Roles & Responsibilities: Working as part of a high-performance project team, the document controller shall organise and maintain the Project Document Plan and provide the team with updates on a timely basis. Quality checks all documentation prior to sharing with client. Assist in the preparation of technical documents. Distribute reports & updates to Project Teams. Record and issue project meeting minutes as required. Store documentation as per Project Management and Document Control procedures. Maintain confidentiality around sensitive information in line with legal regulations. Provide guidance to users in correct use of document management system to ensure consistency of system usage. Assist with audit preparation and support. Participation in ad hoc project work and other administrative duties as requested by the Project Management Team. Provide day-to-day support to the project team and ensure quality systems are executed appropriately according to requirements. Qualifications & Skills: Ideally possess 2 years experience working in a Document Controller/Engineering/Project Administration position coming from an engineering/construction environment. Familiar with Quality Standards/Document Control Procedures Excellent planner and organizer with strong communication skills Dependable team player with strong leadership skills Ability to prioritise workload. Attention to detail. Self-motivated/able to work on their own initiative. Strong administration skills and IT literate, i.e., EDMS software, MS Office suite, SharePoint etc. **H&MV Engineering is an equal opportunity employer**
Posted 1 week ago
3.0 - 8.0 years
5 - 10 Lacs
Hubli, Mangaluru, Mysuru
Work from Office
Filtrex Technologies Pvt. Ltd. As a part of the global industrial organization Marmon Holdings which is backed by Berkshire Hathaway you ll be doing things that matter, leading at every level, and winning a better way. We re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone s empowered to be their best. We are seeking a detail-oriented and proactive Regulatory Certification Engineer to maintain product certifications for the KX Technologies and Filtrex portfolios. This role ensures timely submission of certification applications, supports internal teams with regulatory guidance, and contributes to strategic certification initiatives. The ideal candidate will stay current with global standards and provide exceptional service to both internal and external stakeholders. This position will be based out of Bangalore, India. Job Requirements Manage end-to-end certification processes for new and existing products. Ensure compliance with relevant industry standards and regulatory requirements. Prepare and submit applications for product certifications and registrations. Act as a liaison between internal teams, customers, and certification bodies. Support customer-owned product certifications and related documentation. Maintain accurate records of certification activities and financial transactions. Monitor regulatory changes and ensure ongoing compliance. Identify and implement process improvements in certification workflows. Participate in relevant industry committees and certification-related projects. Professional and Technical Skill Requirements Bachelor s degree required, technical field preferred (e.g., Chemistry, Engineering, Biology) Minimum 3 years of experience with regulatory affairs, drinking water preferred Strong knowledge of NSF/ANSI DWTU and DWA standards and certification required Familiarity with ACS, Halal, KC, KTW, WRAS, JIS certification preferred Knowledge of BIS, AS/NZS, ABNT, EU DWD standards is a plus Excellent written and verbal communication skills Understanding of change management and document control processes Strong organizational skills and project management abilities Proficiency in Access Database or Epicor is an advantage Why Join Us? Work with a global leader in water filtration technologies. Be part of a collaborative and innovative team. Contribute to products that impact health and sustainability worldwide. Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .
Posted 1 week ago
1.0 - 3.0 years
2 - 3 Lacs
Sriperumbudur
Work from Office
Responsibilities: * Ensure compliance with quality standards. * Maintain accurate records. * Collaborate with cross-functional teams. * Manage document flow from creation to archiving. Health insurance Performance bonus Office cab/shuttle Free meal
Posted 1 week ago
8.0 - 13.0 years
10 - 20 Lacs
Gurugram, Bengaluru, Mumbai (All Areas)
Work from Office
Description Managing a companys documents, ensuring accuracy, organization, and security throughout the document lifecycle, includes tasks like scanning, uploading, and distributing documents, as well as maintaining version control and record retention. A Document Controller is responsible for managing, organizing, and maintaining an organization's documentation and records They play a crucial role in ensuring that documents are appropriately stored, accessible, and up-to-date The position requires attention to detail, strong organizational skills, and the ability to work effectively with different teams to facilitate efficient document management processes. Key Responsibilities: Document Management : Receive, process, and organize various types of documents, including contracts, technical reports, correspondence, drawings, and other relevant records Ensure all documents are correctly named, numbered, and filed in a logical and easily retrievable manner Implement document version control to avoid confusion and maintain document history Keep track of document approval and review processes Document Control System:Utilize document management software or other electronic systems to manage and track documents efficiently Provide training and support to employees on the proper use of the document control system Ensure the document control system complies with company standards and industry regulations Distribution and Retrieval:Manage the distribution of documents to authorized personnel, both internally and externally, while ensuring appropriate access permissions Monitor and track document retrieval requests, ensuring timely responses and maintaining records of document movement Quality Assurance:Perform periodic audits of documents to verify accuracy, completeness, and compliance with established procedures and standards Report any discrepancies or non-conformities to the relevant parties and work with them to resolve issues Document Security and Confidentiality:Ensure sensitive and confidential documents are appropriately protected and accessible only to authorized personnel Adhere to data protection and privacy policies to maintain the confidentiality of sensitive information Collaboration : Collaborate with various departments, project teams, and stakeholders to gather and compile documentation for different projects or purposes Facilitate effective communication and information sharing among team members Record Retention:Manage the retention and disposal of documents in accordance with the organization's policies and legal requirements Continuous Improvement:Identify opportunities for streamlining document control processes and implementing best practices Propose and implement improvements to enhance document management efficiency Requirements: Bachelor's degree or equivalent qualification in a relevant field Proven experience as a Document Controller or in a similar role Familiarity with document management software and electronic document control systems Excellent organizational skills and attention to detail Strong communication and interpersonal skills
Posted 1 week ago
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