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3.0 - 7.0 years

0 Lacs

bangalore, karnataka

On-site

As a Senior Medical Writer, your role will involve summarizing published literature in a concise and meaningful manner, aligning it with the objectives provided by the client. You will need to develop content with minimal or no plagiarism, drawing from your expertise in exploring medical literature search engines like Pubmed. Your proficiency in Microsoft software, including Word, PowerPoint, and Excel, will be essential in delivering high-quality content within project timelines. Your strong communication skills will enable you to troubleshoot efficiently and compile scientific content according to project requirements. Additionally, you will format documents following standard operating procedures using MS Office products and recommend journals based on document quality. Conducting detailed literature reviews on specific topics and reviewing client-provided documents will be key responsibilities in this role. Qualifications: - BDS, MDS, or PhD with publication experience in peer-reviewed journals - Life Science PhD in Biochemistry, Microbiology, or Biotechnology with publication experience in peer-reviewed journals Desired Skills: - Manuscript writing experience would be advantageous Join our team to contribute your expertise and skills in medical writing, collaborating with project managers to deliver high-quality scientific content efficiently.,

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3.0 - 7.0 years

3 - 5 Lacs

thane

Work from Office

Job Summary : We are seeking an experienced Document Controller (4 to 6 years) from the Construction, Building Material, or Facade industry to manage documentation across multiple departments and ensure accuracy, compliance, and seamless workflow. Key Responsibilities : Organize, review, and maintain technical and project documents (contracts, drawings, manuals, workflows). Standardize document templates, track revisions, and control version updates. Manage documentation flow across departments Design, Procurement, Operations, Site. Safeguard sensitive records while ensuring accessibility for internal teams and clients. Support efficient digital and physical filing systems. Desired Candidate Profile Degree/Diploma in Mechanical or Civil Engineering. 46 years experience in Construction, Building Material, or Faade industry. Strong proficiency in MS Office (Word, Excel, Outlook). Detail-oriented, organized, and deadline-driven. Excellent communication skills (written & verbal). Why Join Us? Work with a leading faade solutions company delivering iconic projects across India. Collaborative work environment with exposure across multiple departments. Opportunities for learning, growth, and professional development. Be part of a company committed to precision, quality, and innovation

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2.0 - 5.0 years

2 - 5 Lacs

bengaluru

Work from Office

Role: Senior Process Executive/Process Specialist Exp: 1 - 2+ Years Budget: 3.5 LPA - 5.5LPA Location: Bangalore Flexible Shift Only International Banking experience, Experience in Documents review in Banking Domain Immediate joiner 8489756652 Ramya

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0.0 - 1.0 years

2 - 3 Lacs

pune

Work from Office

• Identify and pursue new sales leads, prospects, and business opportunities. • Build and maintain strong relationships with existing and potential clients. • Conduct product presentations, negotiations, and close sales effectively.

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3.0 - 6.0 years

6 - 9 Lacs

hyderabad

Work from Office

The quality inspector shall travel to various supplier facilities to perform visual and dimensional inspections on composite parts. Responsibilities Utilize various inspection tools such as calipers, micrometers, thread gauges checks dimensions/processes on parts or raw material to ensure compliance to manufacturing drawings / blueprints / specifications Work closely with Design Engineering, Project Engineering and Manufacturing to ensure that all manufacturing and inspection activities are performed in compliance with process work documents and customer requirements Ensures that in-process inspections are completed per engineering specifications during the production process Perform mechanical, visual and dimensional inspections of parts using inspection hand tools. Document and facilitate disposition of any nonconforming material discovered during the inspection process Perform receiving document review to ensure unbroken traceability to the respective OEM Create approval/reject tags and document in the requisite databases Perform First Article Inspections (FAI) to AS9102 guidelines ensuring the manufacturing processes are capable of producing parts that conform to specification and contractual agreements Perform Final Inspection as required. Interface with customer portals using Net-Inspect and/or customer specified software Perform verification/calibration of inspection, measuring and test equipment and associated tools Perform Internal Audits to ensure that procedures, processes and protocols are being followed and are effective in their purpose as prescribed by the Quality Management System Perform additional duties as assigned by the Quality Assurance Manager Qualifications Experience with First Article Inspections (AS9102) Candidate Must have composite material experience Possess general knowledge of Aerospace Quality Systems and International Standards Must be familiar with standard concepts, practices and procedures with regards to inspection including proficiency in the use of CMM, comparator, micrometers, thread gauges and calipers The ability to read blue prints , check dimensional properties of parts or raw material to ensure compliance to manufacturing drawings/blueprints and psecifications Knowledge of Discus preferred Must be proficient in the use of Microsoft Suite products. Knowledge of GD&T required 5 or more years of experience in aerospace

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5.0 - 9.0 years

7 - 11 Lacs

hyderabad

Work from Office

Roles Responsibility Support to Line Manager and Lead to execute Seed processing activities following applicable standards and procedures meeting the functional objective, budget and timeline. Build strong relationships and work closely with internal stakeholders teams to ensure that delivery meets the needs of internal external customers. Oversee daily seed processing operations including cleaning, Blending, Treatment coating, Drying and seed disinfection process. Regularly interact with supply planning teams for efficient shop floor planning to maintain inventory levels of ready seeds and Bulk readiness for packing as per demand file. Coordinate with shop floor team and plan daily / weekly processing activities on floor, considering demand file and RAW inventory. Ensure to follow all preset quality protocols and implement in processing operations. Address report quality issues promptly and implement corrective actions. Monitor the quality of processed seeds to ensure they meet purity, germination, and Seed -health standards. In consultation with Line Manager, arrange need based document review implement standard operating procedures (SOPs) for seed processing operations. Organize and ensure to maintain hygiene cleanliness on processing shopfloor facility (5S) Regularly monitor and report on key performance indicators (KPIs) related to processing efficiency and production output. Identify training needs for processing staff and facilitate skill development opportunities Provide on job training to operators, subordinates coordinate for equipment troubleshooting in a timely manner to avoid any delays and standby time. Make timely decisions to improve productivity by maximizing equipment utilization and optimizing maintenance schedules Accountabilities Maintain bulk readiness by having 90 days of processed stock for supply at any point of time. Identify and recommend equipment upgrades or new technologies to improve efficiency Ensure compliance with safety regulations and industry standards Complete the processing of all RAW batches within 120 days after Goods Receipts in system. Practice and monitor SOP s for achieving full compliance and functional excellence in key areas Generates effective communications, good relations and a positive image with internal stake holders, suppliers and co-workers, promoting teamwork. Authorised to identify and initiate corrective action of non-conformance in documentation, design, equipment, facilities, and processes including those activities covered by the Quality System; HSE, Compliance and Documentation Train the processing team on HSE policy and Standards Ensure all Near Misses, Unsafe acts and conditions are captured and reported timely to promote safety first culture in plant Enforce safety protocols and ensure proper use of engineering, administrative and personal protective equipment (PPE) Stay updated on changes in seed processing regulations and industry best practices Manage proper safe handling and disposal of seed treatments and chemicals Conduct regular safety training and drills for the processing team Knowledge, experience & capabilities Minimum Graduate Degree in any Engineering / Agriculture sciences / Seed Technology Having min. 3+ years experience on shop floor, preferably in vegetable seed industry Must be having excellent analytical & communication skills. Preferably to have sound knowledge in Seed Processing technologies and seed disinfection operations A dynamic & determined individual, highly driven, committed and results-orientated with significant pace, energy and confidence. Critical success factors & key challenges Maintain productivity and defect free seed for treatment, drying and packing. Sound knowledge in seed processing The flexibility and adaptability to be able to respond rapidly to unexpected events, and the ability to develop creative solutions to problems. Able to challenge existing thinking in a positive way whilst building credibility and trust through experience and personal style. Flexible working in shifts and ready to operate for 6 days in week considering business requirement. Promote safety and quality culture within and outside team

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8.0 - 13.0 years

25 - 30 Lacs

mumbai

Work from Office

RINA is currently recruiting for a Site Engineer Civil to join its office in Mumbai within the Civil Engineering Division. Mission The role is focuses on managing construction activities to ensure they adhere to project specifications, quality standards, safety regulations, envirnomental issues and are completed on time and within budget by coordinating the work of construction teams and subcontractors. Key Accountabilities 1. Project Development: Develop construction projects from initiation to completion, ensuring adherence to design, specifications, and applicable regulations. 2. Document Review: Review accountable documents and prepare official deliverables vs Contractor. 3. Quality Control: Implement and monitor quality control procedures to maintain the highest construction quality standards. 4. Project Scheduling: Develop and maintain project schedules, ensuring timely progress. Identify and address delays or issues that may impact project timelines. 5. Resource Coordination: Coordinate with subcontractors, suppliers, and internal teams to ensure the availability of necessary resources, materials, and equipment. 6. Cost Management: Monitor project expenditures and provide input on cost control measures to keep projects within budget. 7. Safety Compliance: Collaborate with the Construction Safety Senior Engineer to ensure all work is performed in adherence to safety regulations and best practices. 8. Issue Resolution: Identify and resolve technical issues and challenges that arise during construction. 9. Progress Reporting: Prepare and submit regular progress reports to project stakeholders, highlighting key accomplishments, issues, and proposed solutions. 10. Contractor Claims Management: Support the principal engineer in managing Contractor claims. 11. Change Management: Handle changes in project scope, schedule, or design. Ensure that all necessary adjustments are communicated and implemented. 12. Document Management: Maintain project documentation, including plans, drawings, and records of project-related communications. 13. On-Site Support: Provide direct day-to-day support and oversight of project elements, including site visits to take measurements. 14. Engineering Support: Provide direct or indirect support to engineers or engineering teams by gathering data for permit applications and submitting documentation to officials. 15. Project Timeline Development: Develop project schedules and deliverable timelines under the supervision of more experienced engineers. 16. Technical Deliverables: Prepare technical deliverables, such as technical reports, project performance documentations, and engineering drawings. 17. Progress Reports: Generate progress technical reports to keep stakeholders informed about project advancements. 18. Quality Management: Be aware of and understand the Quality Policy, ensuring that all assigned activities are executed in accordance with the RINA Quality Management System (QMS). Education Doctorate/PHD in Civil Engineering Qualifications Professional Engineer (PE) license is highly desirable. Certification in Construction Management or related fields is an advantage. Proven experience (8+ years usually) in construction supervision, preferably in civil engineering or construction projects. Solid understanding of construction principles, techniques, and practices Proven experience in monitoring and overseeing construction projects from initiation to completion. Competencies ADDRESS THE WAY - Have a big picture of different situations and reinterpret it in a perspective way BUILD NETWORK - Forge trust relationships, across departments, and outside the organization CLIENT INTIMACY - Embrace internal and external client needs, expectations, and requirements to ensure maximum satisfaction EARN TRUST - Take everyones opinion into account and remain open to diversity MAKE EFFECTIVE DECISIONS - Structure activities according to priorities, actions, resources and constraint MANAGE EMOTIONS - Recognise ones and others emotions and express and regulate ones reactions PIONEER CHANGE - Actively embrace change and benefit from the new circumstances PROMOTE SUSTAINABLE DEVELOPMENT - Promote commitment by keeping promises as a Role Model THINK FORWARD - Capitalise on experiences and translate them into action plans for the future

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8.0 - 13.0 years

25 - 30 Lacs

mumbai

Work from Office

RINA is currently recruiting for a Quality Assurance Expert (Civil) to join its office in Mumbai within the Civil Engineering Division. Mission The role is focuses on managing construction activities to ensure they adhere to project specifications, quality standards, safety regulations, envirnomental issues and are completed on time and within budget by coordinating the work of construction teams and subcontractors. Key Accountabilities 1. Project Development: Develop construction projects from initiation to completion, ensuring adherence to design, specifications, and applicable regulations. 2. Document Review: Review accountable documents and prepare official deliverables vs Contractor. 3. Quality Control: Implement and monitor quality control procedures to maintain the highest construction quality standards. 4. Project Scheduling: Develop and maintain project schedules, ensuring timely progress. Identify and address delays or issues that may impact project timelines. 5. Resource Coordination: Coordinate with subcontractors, suppliers, and internal teams to ensure the availability of necessary resources, materials, and equipment. 6. Cost Management: Monitor project expenditures and provide input on cost control measures to keep projects within budget. 7. Safety Compliance: Collaborate with the Construction Safety Senior Engineer to ensure all work is performed in adherence to safety regulations and best practices. 8. Issue Resolution: Identify and resolve technical issues and challenges that arise during construction. 9. Progress Reporting: Prepare and submit regular progress reports to project stakeholders, highlighting key accomplishments, issues, and proposed solutions. 10. Contractor Claims Management: Support the principal engineer in managing Contractor claims. 11. Change Management: Handle changes in project scope, schedule, or design. Ensure that all necessary adjustments are communicated and implemented. 12. Document Management: Maintain project documentation, including plans, drawings, and records of project-related communications. 13. On-Site Support: Provide direct day-to-day support and oversight of project elements, including site visits to take measurements. 14. Engineering Support: Provide direct or indirect support to engineers or engineering teams by gathering data for permit applications and submitting documentation to officials. 15. Project Timeline Development: Develop project schedules and deliverable timelines under the supervision of more experienced engineers. 16. Technical Deliverables: Prepare technical deliverables, such as technical reports, project performance documentations, and engineering drawings. 17. Progress Reports: Generate progress technical reports to keep stakeholders informed about project advancements. 18. Quality Management: Be aware of and understand the Quality Policy, ensuring that all assigned activities are executed in accordance with the RINA Quality Management System (QMS). Education Doctorate/PHD in Civil Engineering Qualifications Professional Engineer (PE) license is highly desirable. Certification in Construction Management or related fields is an advantage. Proven experience (8+ years usually) in construction supervision, preferably in civil engineering or construction projects. Solid understanding of construction principles, techniques, and practices Proven experience in monitoring and overseeing construction projects from initiation to completion. Competencies ADDRESS THE WAY - Have a big picture of different situations and reinterpret it in a perspective way BUILD NETWORK - Forge trust relationships, across departments, and outside the organization CLIENT INTIMACY - Embrace internal and external client needs, expectations, and requirements to ensure maximum satisfaction EARN TRUST - Take everyones opinion into account and remain open to diversity MAKE EFFECTIVE DECISIONS - Structure activities according to priorities, actions, resources and constraint MANAGE EMOTIONS - Recognise ones and others emotions and express and regulate ones reactions PIONEER CHANGE - Actively embrace change and benefit from the new circumstances PROMOTE SUSTAINABLE DEVELOPMENT - Promote commitment by keeping promises as a Role Model THINK FORWARD - Capitalise on experiences and translate them into action plans for the future

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8.0 - 13.0 years

18 - 22 Lacs

pune

Work from Office

Key Responsibilities Collaborate with customer teams to align playbook content that needs to be created in the AI Assistance tools. Design and structure a comprehensive legal playbook focused on contract risk assessment. Define risk categories, thresholds, mitigation strategies , and escalation protocols in the playbook. Able to use the AI tool to test the playbooks to achieve the desired outcomes. Collaborate with cross-functional teams including engineers, and customer stakeholders to deliver impactful AI based solutions. Demonstrate basic understanding of technology and IT processes. Incorporate feedback from stakeholders and AI tool outputs to refine risk definitions and workflows. Monitor solution performance and provide data-driven recommendations for enhancements and optimization. Prepare and present reports, documentation, and demos to clients and senior leadership, showcasing progress and insights. Qualifications Bachelors or Master’s degree in Law, Legal Studies, or related field. 5+ years of experience in contract law, legal risk management, or compliance. Familiarity with AI tools used in legal tech (e.g., contract analysis platforms, LLM-based assistants). Strong analytical and writing skills with the ability to translate complex legal concepts into structured documentation. Experience with legal operations, playbook creation, or policy drafting is a plus. Preferred Skills Understanding of AI/ML concepts and their application in legal workflows. Experience with AI based SaaS platforms like Icertis, Ironclad, Kira Systems, Luminance, or similar. Ability to manage cross-functional projects and communicate effectively with technical and non-technical stakeholders.

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3.0 - 8.0 years

4 - 8 Lacs

hyderabad

Work from Office

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 20.09.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D, API R&D Candidates also eligible for this positions Position : Executive / Senior Executive Qualification : M.Sc, M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 20.09.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786

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5.0 - 8.0 years

8 - 13 Lacs

pune, vadodara

Hybrid

We are seeking an experienced Legal Counsel with strong expertise in , contracts and regulatory compliance to join our legal team. The role involves providing comprehensive legal support across the organization especially as related IT sector, with a particular focus on matters related to corporate contracts India and foreign countries, and regulatory compliance. This position will perform end to end contract services and be accountable for delivering positive customer experiences and efficient business results. Qualification 5+ years of Corporate experience in IT industry Have the expose of working for foreign geo-US/EU regions LLB (Mandatory) LLM (preferred)/foreign qualification Skills & Competencies Excellent legal drafting and negotiation skills. Strong analytical and problem-solving ability. Business-oriented approach with sound risk judgment. Ability to manage multiple priorities and work under pressure. Strong communication and stakeholder management skills. High level of integrity and professional ethics. You will perform end to end contract preparation and execution processes for assigned portfolio of transactions, beginning with receipt of requests for contract generation through contract signature for India and global clients. • Receive contract requests and conduct triage to ensure adherence to established business policies, processes and procedures • Review, draft and negotiate routine vendor and commercial contracts including confidentiality/non-disclosure agreements, software license agreements and related support service agreements, consulting services agreements, and other agreements routinely used in IT service sector. • Ensure that all agreements are prepared, revised and executed in consultation with the business unit client and other subject matter experts, and in accordance with approved policies and playbooks • Analyze contract requirements, special provisions, terms and conditions to ensure compliance with appropriate laws, regulations, policies and procedures • Provide superior customer service according to the Ascendion standards in terms of quality, response time, resolution time and adhering to Service Level Objectives. Handled foreign contract /compliance matter.

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2.0 - 3.0 years

4 - 5 Lacs

mumbai

Work from Office

To work on and support a wide range of forensic projects and write clear, detailed and analytical reports. Role tasks and responsibilities - Provide support for forensic accounting and investigation engagements, including transaction testing, interviews, document review, financial statement analysis and data visualisation in South Asia. - Provide support as part of a team delivering large, multijurisdictional assignments and complex problem solving projects. - Provide day-to-day operational support to other members of the practice to ensure effective management and prioritisation of all incoming client requests and outgoing deliverables. - Carry out public domain research in English. - Support several small to mid-sized projects, with minimal supervision. - Assist and support senior team members in presenting to prospective and current clients (e.g.: preparing presentations) - Two to three years of experience with a reputable public accounting firm, and/or in-house compliance/investigations role or a similar role with multinational corporations in India. - Excellent analytical, presentation and report-writing skills. - Flexible in adapting to evolving priorities during the course of an investigation. - Strong professional work ethics and willing to develop new skills. - Proficient in English, both spoken and written. - Relevant university degree. - Willing to travel. - Close attention to detail. - Ability to multi-task and handle multiple commitments under time pressure.

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1.0 - 6.0 years

1 - 1 Lacs

manesar

Work from Office

Seeking a Back Office Coordinator for report making and data entry. Responsibilities include managing records, preparing reports, and data processing.

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4.0 - 8.0 years

0 Lacs

andhra pradesh

On-site

As a Legal Advisory Officer at Miracle Software Systems in Visakhapatnam, you will play a crucial role in managing various legal aspects of the organization. Your responsibilities will include: - Vendor Management - Client Negotiations - Contract Management - Document Review - Drafting Legal agreements such as Statement of Work (SOW) and Master Service Agreement (MSA). - Experience in handling Legal & Contract Management for U.S. process - Hands-on experience with Vendor contracts and Client Contracts - Negotiating with tier one IT companies and different vendors of manpower solutions - Maintaining the client contract database and utilizing CLM tools - Drafting, reviewing, and negotiating Non-Compete/Non-Disclosure/Master Service agreements and contracts in compliance with company policies - Setting up basic legal processes and systems to manage all legal documents - Coordinating with external lawyers, contractors, vendors to negotiate and resolve legal and operational issues - Handling all domestic legal issues for the organization - Managing Contractual Issues and negotiating with Vendors and Clients via emails or phone calls - Providing status updates of contract negotiations to the Management Qualifications required for this role: - 4+ years of experience in a similar role - Strong understanding of legal and contractual matters - Excellent communication and negotiation skills - Familiarity with CLM tools and legal processes - Ability to work independently and as a part of a team Join Miracle Software Systems to utilize your legal expertise and make a significant impact on the organization's legal operations.,

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0.0 - 5.0 years

1 - 1 Lacs

manesar

Work from Office

Seeking a Back Office Coordinator for report making and data entry. Responsibilities include managing records, preparing reports, and data processing.

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3.0 - 8.0 years

3 - 8 Lacs

hyderabad/ secunderabad

Work from Office

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry. A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ensuring compliance with safety, regulatory, and cGLP standards. Preferred Manager profile: Design and implement robust QC procedures aligned with current Good Manufacturing Practices (cGMP) and industry standards. Ensure processes are optimized for efficiency, accuracy, and compliance. Regularly assess QC operations and procedures. Identify opportunities for improvement and implement enhancements to streamline workflow and ensure regulatory readiness. Ensure QC operations comply with global regulatory authorities including USFDA, EDQM, ANVISA, PMDA, and WHO. Maintain audit readiness and lead/support regulatory inspections. Team Leadership and Development Manage and mentor a team of QC professionals, ensuring high performance and ongoing professional development. Assign responsibilities, monitor progress, and promote a culture of accountability and collaboration. Data Integrity and Documentation Ensure accuracy, reliability, and confidentiality of all laboratory records and data. Enforce adherence to ALCOA+ principles for data integrity. Troubleshooting and CAPA Management Investigate quality-related issues, perform root cause analysis, and lead implementation of effective corrective and preventive actions (CAPAs). Cross-functional Collaboration Collaborate with AR&D, QA, and other departments to align quality strategies. Communicate quality metrics, performance, and issues to leadership and stakeholders. Quality System Contributions Support development and implementation of quality management systems (QMS). Review and approve analytical methods, validation protocols, and reports. Audit and Complaint Management Lead or support internal and external audits. Manage customer complaints and conduct trending analysis to drive quality improvements. Technical Skills: Hands-on experience and data interpretation of analytical instruments like LCMS, HPLC, GC,UV, KF, etc. Thorough understanding of cGMP, GLP, and regulatory requirements. Good documentation and analytical skills. Job Description: QC Data Review Specialist Job Summary We are seeking a meticulous and highly organized QC Data Review Specialist to join our Quality Control team. The successful candidate will be responsible for the comprehensive GMP (Good Manufacturing Practices) review of laboratory raw data, analytical reports, and related documentation. This role is critical to ensuring that all laboratory work is performed in compliance with established methods and protocols, that results are analytically sound and accurate, and that all documentation adheres to stringent GMP standards and regulatory requirements. Key Responsibilities Data and Document Review: Conduct detailed reviews of analytical data packages, including but not limited to raw data (e.g., chromatograms, spectra), laboratory notebooks, and summary reports for accuracy, completeness, and compliance with GMP. Compliance Verification : Ensure all testing was performed according to approved SOPs, analytical methods, and protocols. Verify that calculations and data transcriptions are correct and that any deviations or out-of-specification (OOS) results are properly documented, investigated, and reported. Method Validation Review : Review method validation/verification/transfer protocols and reports to ensure they meet regulatory and company standards. Stability Program Suppor t: Review stability testing data and reports, ensuring that data integrity is maintained throughout the stability study lifecycle. Audit Trail Review : Perform audit trail reviews of electronic data systems to ensure data integrity and identify any potential compliance risks. Documentation Management : Assist in the revision and approval of controlled documents such as SOPs, test methods, and specifications. Communication: Collaborate closely with laboratory analysts to resolve documentation errors, clarify discrepancies, and provide constructive feedback to prevent future issues. Act as a liaison between the QC laboratory and the Quality Assurance (QA) department. Continuous Improvement : Identify gaps in procedures and opportunities for improvement within the laboratory data review process to enhance efficiency and compliance. Qualifications Education: Bachelor of Science (B.S.) degree in Chemistry, Biology, Biochemistry, or a related life sciences field is required. Experience: A minimum of 3-8 years of hands-on experience in a GMP-regulated pharmaceutical or biotechnology laboratory environment. Direct experience in reviewing analytical data (e.g., HPLC, GC, UV-Vis, FTIR, wet chemistry) is essential. Prior experience in a dedicated data review or QA role is highly preferred. Knowledge: In-depth knowledge of GMP, GDP (Good Documentation Practices), and data integrity principles. Strong understanding of FDA, ICH, and other relevant regulatory guidelines. Familiarity with common laboratory software and electronic data systems (e.g., LIMS, Chromeleon, Empower). Required Skills and Competencies Attention to Detail: Exceptional ability to spot errors, inconsistencies, and deviations in complex technical documents. Analytical and Critical Thinking: Strong ability to interpret scientific data and assess its validity and compliance. Organizational Skills: Excellent time management skills with the ability to manage multiple review assignments and meet deadlines. Communication Skills: Clear and effective written and verbal communication skills are necessary to articulate findings and collaborate with team members. Problem-Solving: Proactive in identifying issues and working with the team to find compliant solutions. Integrity: Must uphold the highest standards of quality and ethical behavior. Teamwork: Ability to work effectively both independently and as part of a collaborative team. Behavioral & Leadership Skills: Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Demonstrated ability to lead cross-functional teams and drive a culture of quality. Why JanSat? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As JanSat focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.

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2.0 - 5.0 years

1 - 6 Lacs

hyderabad

Work from Office

Position Overview: The Associate Docs to Stips Specialist is responsible for accurately associating borrower-provided documentation to the appropriate underwriting conditions (stips) within the loan origination system. This role requires attention to detail, familiarity with mortgage documentation, and the ability to work efficiently in a fast-paced, paperless environment. The ideal candidate will demonstrate strong organizational skills, effective communication, and a commitment to quality and compliance Essential Job Functions: - Review and analyze borrower-provided documents for completeness and relevance. - Accurately associate documents to the correct underwriting conditions (stips) in the system. - Ensure all documentation meets investor and company guidelines. - Update LOS screen, review risk messages for action, Clear data validators as risk message reviews are completed, Run decision engine along with fee/pricing engine if applicable with LOS updates - Review credit report for names and other infirmation - Communicate with internal teams to clarify documentation requirements. - Maintain productivity and quality standards as defined by management. - Identify and escalate discrepancies or missing documentation. - Utilize checklists and system tools to verify documentation accuracy. - Support underwriters and processors by ensuring timely and accurate document association. - Maintain up-to-date knowledge of document types and underwriting requirements. - Adhere to company policies, procedures, and compliance standards. Requirements: - 23 years of experience in mortgage processing or document review preferred. - Familiarity with mortgage documentation and underwriting conditions. - Ability to follow complex task process and complete notation and documentation - Strong attention to detail and organizational skills. - Excellent written and verbal communication skills. - Ability to work independently and meet deadlines in a high-volume environment. - Proficiency in Microsoft Office and loan origination systems. - Commitment to maintaining confidentiality and data integrity.

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1.0 - 6.0 years

7 Lacs

chennai

Work from Office

Roles and Responsibilities: Candidates with min 1 - 8 years of experience in AML - Transaction Monitoring AML level 1 detection is mandatory Review of assigned alerts and document findings using the AML alert management system. Review of Manual referrals generated by different areas of the bank. Review and analysis on Low, Medium and High Risk accounts Conduct enhanced due diligence research of individuals, institutions and trust through LexisNexis and other internet tools. Interact with Bank management on suspicious transactions conducted by customers. Prepare and review Loan accounts, RDC (Remote Deposit Capture), Wire Transfers and Monetary Instrument reports Use transactional and customer records, external data, publicly- available information, and other information to identify suspicious or unusual activity. Performed detailed analyses to detect patterns, trends, anomalies and schemes in transactions and relationships across multiple businesses/products. Maintain strong investigative skills; the ability to work independently, demonstrated extensive banking and Compliance knowledge. Identified multiple significant cases, red flags and patterns associated with the laundering of illicit funds. Should be flexible for night shifts .

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3.0 - 7.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

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2.0 - 6.0 years

0 Lacs

pune, maharashtra

On-site

As a Purchase Agreement Review Specialist at Digital Risk, your primary responsibility will be to review and validate purchase agreements and related documentation to ensure adherence to company policies and investor guidelines. Your role will involve verifying property details, buyer/seller information, and contract terms, as well as identifying and resolving discrepancies in documentation. Effective communication with internal and external stakeholders is essential, along with maintaining knowledge of current regulatory and investor requirements. Key Responsibilities: - Review purchase agreements and related documents for accuracy and completeness - Verify property details, buyer/seller information, and contract terms - Ensure compliance with investor and company guidelines - Identify and resolve discrepancies or missing information in documentation - Coordinate with internal teams for necessary documentation or clarification - Update loan origination systems with accurate information - Communicate effectively with stakeholders for smooth processing - Support underwriting and processing teams with document validation - Prioritize daily workflow to meet productivity and quality standards Qualifications Required: - 2-4 years of experience in mortgage or financial services focusing on document review - Strong understanding of purchase agreements and real estate documentation - Excellent attention to detail and organizational skills - Strong written and verbal communication skills - Ability to follow complex task processes and complete documentation - Ability to work independently and manage multiple tasks - Proficiency in Microsoft Office and loan origination systems - Comfortable working in a paperless, fast-paced environment - Availability to work U.S. hours Digital Risk is a leading mortgage outsource provider in the U.S., with a team of over 1,500 professionals dedicated to delivering top-notch appraisal and mortgage processing services to major banks and loan originators. Join us in our mission to Make Mortgages Safe by leveraging your skills and expertise as a Purchase Agreement Review Specialist.,

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7.0 - 10.0 years

6 - 12 Lacs

thane

Work from Office

About the Role: We are seeking a highly independent and detail-oriented Lease Administration Assistant Manager to lead our Abstraction Services team. This role offers an exciting opportunity to enhance your skills and play a pivotal role in delivering consistent, high-quality Lease Administration Abstraction services for JLL clients. Key Responsibilities: Team Management: Lead and manage a team of abstractors and double checkers Oversee administrative matters and participate in recruitment processes Provide mentorship and guidance to team members Foster an environment that supports teamwork, cooperation, and performance excellence Operational Excellence: Ensure timely and accurate delivery of abstraction services Maintain and improve processes to adhere to internal and external policies Manage portfolio reviews, reporting, and resource planning Monitor and optimize key performance indicators (KPIs) including quality, turnaround time, and productivity Client and Stakeholder Management: Act as the primary contact for escalations related to abstraction services Collaborate with internal stakeholders to resolve issues and implement improvements Work closely with 3rd party vendors Maintain effective communication with regional business relations Continuous Improvement: Collaborate with the Regional Abstraction Manager to drive performance improvements Identify and share best practices within the team Manage and execute ad-hoc projects to enhance service delivery Contribute to the transition and implementation of new client accounts Qualifications: University degree (Graduate/Postgraduate); MBA or PMP certification is preferred Minimum 6 years of industry experience in corporate, third-party service provider, or consulting environments Strong knowledge of real estate leases and accounting principles Proficiency in property management/lease administration systems Excellent project management and team leadership skills Advanced proficiency in Microsoft Office suite, particularly Excel Outstanding verbal and written communication skills Demonstrated ability to manage multiple projects and priorities simultaneously Strong attention to detail and commitment to data accuracy Ability to work independently with minimal supervision Prior experience of double checker is preferred Should be comfortable working in an Evening Shift (5:30 pm to 2:30 am) Desired Skills: Critical and innovative thinking capabilities Strong reading comprehension and paraphrasing skills In-depth understanding of Lease Administration concepts Ability to manage stress and emotions effectively Initiative-taking and problem-solving aptitude Adaptability and receptiveness to new ideas If you are a highly responsible and accountable professional with a passion for lease administration and team leadership, we encourage you to apply for this exciting opportunity.

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7.0 - 10.0 years

6 - 12 Lacs

gurugram

Work from Office

About the Role: We are seeking a highly independent and detail-oriented Lease Administration Assistant Manager to lead our Abstraction Services team. This role offers an exciting opportunity to enhance your skills and play a pivotal role in delivering consistent, high-quality Lease Administration Abstraction services for JLL clients. Key Responsibilities: Team Management: Lead and manage a team of abstractors and double checkers Oversee administrative matters and participate in recruitment processes Provide mentorship and guidance to team members Foster an environment that supports teamwork, cooperation, and performance excellence Operational Excellence: Ensure timely and accurate delivery of abstraction services Maintain and improve processes to adhere to internal and external policies Manage portfolio reviews, reporting, and resource planning Monitor and optimize key performance indicators (KPIs) including quality, turnaround time, and productivity Client and Stakeholder Management: Act as the primary contact for escalations related to abstraction services Collaborate with internal stakeholders to resolve issues and implement improvements Work closely with 3rd party vendors Maintain effective communication with regional business relations Continuous Improvement: Collaborate with the Regional Abstraction Manager to drive performance improvements Identify and share best practices within the team Manage and execute ad-hoc projects to enhance service delivery Contribute to the transition and implementation of new client accounts Qualifications: University degree (Graduate/Postgraduate); MBA or PMP certification is preferred Minimum 6 years of industry experience in corporate, third-party service provider, or consulting environments Strong knowledge of real estate leases and accounting principles Proficiency in property management/lease administration systems Excellent project management and team leadership skills Advanced proficiency in Microsoft Office suite, particularly Excel Outstanding verbal and written communication skills Demonstrated ability to manage multiple projects and priorities simultaneously Strong attention to detail and commitment to data accuracy Ability to work independently with minimal supervision Prior experience of double checker is preferred Should be comfortable working in an Evening Shift (5:30 pm to 2:30 am) Desired Skills: Critical and innovative thinking capabilities Strong reading comprehension and paraphrasing skills In-depth understanding of Lease Administration concepts Ability to manage stress and emotions effectively Initiative-taking and problem-solving aptitude Adaptability and receptiveness to new ideas If you are a highly responsible and accountable professional with a passion for lease administration and team leadership, we encourage you to apply for this exciting opportunity.

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3.0 - 7.0 years

5 - 9 Lacs

mumbai

Work from Office

Location: Mumbai Designation: Deputy Manager Overview: We are seeking a highly analytical and detail-oriented Assistant Manager to join our Forensic & Financial Crime team within the International Capability Centre. This role offers an excellent opportunity to contribute to high-profile, complex engagements across a diverse range of industries, while working in close collaboration with global teams. The ideal candidate will possess strong forensic accounting skills, ideally with experience of working on investigations (including fraud, corruption and regulatory investigations) and / or disputes (including expert witness, advisory and arbitrations). They must have the ability to interpret and analyse financial and documentary evidence, and the confidence to operate with autonomy in a fast-paced and dynamic environment. Strong written and verbal English skills are essential. The team Innovation, transformation, and leadership occur in many ways. At Deloitte, our ability to help solve clients most complex issues is distinct. We deliver strategy and implementation, from a business and technology view, to help you lead in the markets where you compete. Learn more about our Financial Advisory Practice Key Responsibilities As an Assistant Manager in our Forensic & Financial Crime team you ll build and nurture positive working relationships with teams and member firm counterparts with the intention to exceed member firm expectations. You ll: Gain a deep understanding of each client s business model, processes, and procedures, tailoring insights to suit sector-specific risks and dynamics; Assist member firms to investigate allegations of accounting misstatement, fraud, bribery and corruption, including regulatory breaches; Work closely with the Data Management and Analytics team to extract and review both structured (i.e. databases, enterprise systems, etc.) and unstructured (i.e. email messages, audio files, etc.) data to assist in investigations and assessing/monitoring fraud risk; Support engagement teams in identifying, evaluating, and quantifying fraud risks specific to client industries and advising on their implications; Assist member firm with research and analysis for business development purposes; Assist in the preparation of formal investigation interviews; Prepare analysis work to be incorporated into expert witness reports to quantify losses; Assist in the drafting of formal reports in the context of expert witness or investigation assignments; Assist in the drafting of proposal documents for potential new opportunities; Collaborate effectively with member firm counterparts and external stakeholders to gather key information and provide timely engagement updates; Demonstrate a forensic mindset in identifying anomalies, trends, and red flags across data and documents under review; Conduct independent qualitative and quantitative analysis of financial and non-financial documents, producing clear and concise outputs suitable for client delivery; Prepare structured reports and presentations, articulating complex findings clearly, professionally, and client-read; Oversee day-to-day management of workstreams, ensuring deadlines are met and quality and procedural standards are upheld; and Work independently and with minimal supervision, maintaining a high level of accuracy and attention to detail. Skills, Experience & Qualification Qualified Chartered Accountant or equivalent (ACA, ACCA, CPA). A professional certification in fraud examination (e.g. CFE) would be a distinct advantage. A strong academic track record, with attention to detail and a commitment to risk awareness and quality standards. Strong analytical and logical/methodical problem-solving skills, with the ability to synthesize and interpret large volumes of data quickly and accurately. The ability to work as part of a team. Demonstrated ability to manage multiple priorities and deliver high-quality outputs within tight timelines. Excellent interpersonal and communication skills, with a particular strength in concise, well-structured report writing (in English) and document review. Advanced Excel skills for accurate and efficient data manipulation. Adaptable and resilient, capable of navigating dynamic work environments and evolving priorities. Prior experience in forensic investigations, disputes, financial crime, or related advisory services, ideally within a global delivery or cross-border engagement environment is a plus. Sound understanding of business processes and internal controls an advantage. Location and way of working Base location: Mumbai Hybrid is our default way of working. Each domain has customized the hybrid approach to their unique needs. Your role as an Assistant Manager We expect our people to embrace and live our purpose by challenging themselves to identify issues that are most important for our clients, our people, and for society. In addition to living our purpose, an Assistant Manager across our organization must strive to be: Inspiring - Leading with integrity to build inclusion and motivation. Committed to creating purpose - Creating a sense of vision and purpose. Agile - Achieving high-quality results through collaboration and Team unity. Skilled at building diverse capability - Developing diverse capabilities for the future. Persuasive / Influencing - Persuading and influencing stakeholders. Collaborating - Partnering to build new solutions. Delivering value - Showing commercial acumen. Committed to expanding business - Leveraging new business opportunities. Analytical Acumen - Leveraging data to recommend impactful approach and solutions through the power of analysis and visualization. Effective communication Must be well abled to have well-structured and well-articulated conversations to achieve win-win possibilities. Engagement Management / Delivery Excellence - Effectively managing engagement(s) to ensure timely and proactive execution as well as course correction for the success of engagement(s). Managing change - Responding to changing environment with resilience. Managing Quality & Risk - Delivering high quality results and mitigating risks with utmost integrity and precision. Strategic Thinking & Problem Solving - Applying strategic mindset to solve business issues and complex problems. Tech Savvy - Leveraging ethical technology practices to deliver high impact for clients and for Deloitte. Empathetic leadership and inclusivity - creating a safe and thriving environment where everyones valued for who they are, use empathy to understand others to adapt our behaviours and attitudes to become more inclusive. How you ll grow Connect for impact Our exceptional team of professionals across the globe are solving some of the world s most complex business problems, as well as directly supporting our communities, the planet, and each other. Know more in our Global Impact Report and our India Impact Report . [JL1] Empower to lead You can be a leader irrespective of your career level. Our colleagues are characterised by their ability to inspire, support, and provide opportunities for people to deliver their best and grow both as professionals and human beings. Know more about Deloitte and our One Young World partnership. Inclusion for all At Deloitte, people are valued and respected for who they are and are trusted to add value to their clients, teams and communities in a way that reflects their own unique capabilities. Know more about everyday steps that you can take to be more inclusive. At Deloitte, we believe in the unique skills, attitude and potential each and every one of us brings to the table to make an impact that matters. Drive your career At Deloitte, you are encouraged to take ownership of your career. We recognise there is no one size fits all career path, and global, cross-business mobility and up / re-skilling are all within the range of possibilities to shape a unique and fulfilling career. Know more about Life at Deloitte. Everyone s welcome entrust your happiness to us Our workspaces and initiatives are geared towards your 360-degree happiness. This includes specific needs you may have in terms of accessibility, flexibility, safety and security, and caregiving. Here s a glimpse of things that are in store for you [JL2] . Interview tips We want job seekers exploring opportunities at Deloitte to feel prepared, confident and comfortable. To help you with your interview, we suggest that you do your research, know some background about the organisation and the business area you re applying to. Check out recruiting tips from Deloitte professionals.

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1.0 - 6.0 years

3 - 5 Lacs

mohali

Work from Office

#Title : Legal Associate/Sr Legal Associate/Team Leader/Assistant Manager #Experience : 0-10 Yrs #Location : Mohali #Shift Timings- Must be comfortable with Night or Mid Shift. Role Overview: Legal Associate typically involves providing specialized legal services to clients (often law firms or corporate legal departments). These services can range from routine legal tasks to complex legal support, depending on the scope of the clients offerings. What youll do? (Key Responsibilities) Legal Research and Analysis:- Conduct research on statutes, case laws, regulations, and legal precedents. Analyse legal documents and provide summaries or insights to assist attorneys. Drafting and Documentation:- Draft legal documents, such as contracts, agreements, notices, pleadings, and motions. Create templates and standard operating procedures for legal processes. Contract Management:- Review, draft, and negotiate contracts, including NDAs, MSAs, vendor agreements, and employment contracts. Ensure compliance with legal requirements and client-specific standards. Litigation Support:- Summarize depositions, interrogatories, and witness statements. Creating chronologies like medical (Personal Injuries). Administrative and Client Coordination:- Communicate with client representatives and external counsel to ensure a clear understanding of tasks. Provide updates, reports, and deliverables within specified timelines. Must-Have: Education: Bachelor of Law (LLB) or LLM. Minimum of 1 years of experience in LPO or litigation. (personal injury, contract life cycle management, drafting, legal research, etc.). Knowledge of personal injury, contract lifecycle management, drafting, legal research, etc. Excellent attention to detail and accuracy. Strong communication skills for handling client calls/ client queries. Ability to maintain confidentiality and handle sensitive information. Strong problem-solving and time-management skills.

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6.0 - 13.0 years

8 - 15 Lacs

bengaluru

Work from Office

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

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