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5 - 9 years

7 - 12 Lacs

Chennai

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About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards. Responsibilities Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities. Reviewing Product Requirements including Epics, User Stories, and Software Requirements. Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines. Creating realistic test cases and datasets based on real-world customer scenarios. Executing test cases, logging defects, documenting deviations, and reporting test outcomes. Peer reviewing test documentation to ensure quality and adherence to standards. Working collaboratively in a dynamic team environment with open communication. Understanding and adhering to Quality Management System (QMS) standards. Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews. Managing product validation timelines and ensuring quality deliverables. Requirements Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field. At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment. Deep knowledge of the product development life cycle. Understanding of GMP, FDA, and ISO regulations. Proficiency with testing tools and Microsoft Office suite. Self-motivated with a willingness to quickly learn new technologies and products. Excellent interpersonal, writing, communication, and troubleshooting skills. Passionate about testing, validation, and product quality. Able to mentor colleagues and lead small projects efficiently. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

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2 - 6 years

7 - 10 Lacs

Hyderabad, Bangalore Rural, Mumbai (All Areas)

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Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

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7 - 12 years

5 - 10 Lacs

Halol, Vadodara

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Key Responsibilities Quality Strategy & Planning Develop and implement quality control standards, procedures, and policies. Define inspection criteria and quality benchmarks. Team Management Lead and supervise a team of quality inspectors or analysts. Provide training and guidance to QC staff. Manage and supervise QC laboratory activities Use effective negotiation skills to drive alignment and resolve conflict Inspection & Testing Oversee routine inspections and testing of raw materials, in-process, and finished products. Ensure compliance with internal and external specifications and regulations. Documentation & Reporting Maintain detailed records of quality control activities. Analyze QC data and generate reports to identify trends and areas for improvement. Compliance & Audits Ensure compliance with ISO, GMP, or other industry-specific standards. Coordinate and support internal and external audits. Problem Solving Investigate product quality issues and customer complaints. Implement corrective and preventive actions (CAPA).

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7 - 12 years

25 - 35 Lacs

Noida, Chennai, Bengaluru

Hybrid

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Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402 • Strong knowledge of Qualification and Validation project development/implementation processes. • Excellent FDA GxP understanding. • Knowledge of SoX, cGMPs, FDA and EMA guidelines. • Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000 • Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance • Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must. • Good Program/Project management skills along analytics & reporting skills with strong communication & presentation. • Ability to work with all level of clients & internal resources • Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred. JD • Point of contact for client stakeholders as well as HCL Operations team for guidance & support regarding compliance control requirements and implementation into service operations • Create & Document the control compliance plans for all services in scope • Lead Compliance processes for large Pharmaceutical Client for specific geography • Manages the infrastructure Qualification of hardware/Servers. • Maintains categorization of Off-the-shelf validation categories. • Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services • Develop & Plan internal audit calendar aligned to clients internal as well as external audit schedule • Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances • Provide agreed upon and ad-hoc reports for audits & compliance operations. • Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits • Conduct process audits for ITSM as per agreed upon process controls • Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements.

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2 - 6 years

6 - 16 Lacs

Gurugram

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Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

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2 - 5 years

6 - 10 Lacs

Bengaluru

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About The Role : Job Title- Regulatory Filtering Analyst, NCT Location- Bangalore, India Role Description Deutsche Bank (DB) Group and its staff are committed to compliance with all applicable laws and official regulations in the respective jurisdictions. Restrictive measures under sanctions and embargoes are usually implemented by means of statutory regulations. The sanctions and embargoes program is aimed to ensure that DB Group and its staff fully comply with all sanctions and embargoes regulations in force in the respective jurisdiction. For this purpose, DB established a global organization with dedicated rights and responsibilities. DBs Sanctions & Embargoes Program has been implemented globally and throughout all business divisions via the Embargo Policy - DB Group and the Special Risk Country Policy DB Group. The Service Operations (Operations) Profession is responsible for the delivery, oversight and management of functional teams undertaking operational and transaction-based processes, working within agreed policies, procedures, Key Performance and Risk Indicators. Operations objectives include designing and implementing a robust control environment that allows and drives efficient and effective processing. The environment should ensure we meet regulatory requirements and can verify the completeness and accuracy of all transactions and operational processes. The objectives include operational assurance on the integrity of the books & records and deliver effective service to our clients. Operations develop and maintain effective relationships across client and partner groups. The RTB Reviewer are primarily responsible for the appropriate review, confirmation and decision-taking on stopped messages to confirm mismatches for release from the transaction filtering process in line with applicable Sanction regulations and the Banks policies and procedures. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory, and reputational risk regarding business involving sanctioned entities and / or countries. Perform quality assurance review in accordance with AML policies and departmental procedures within established timeframes. Perform timely Quality activities such as day to day quality reviews on alerts processed by RTB users. Update all relevant MI to confirm completion of reviews and errors identified. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Provides insight into quality gaps discovered as part of the quality assurance process and ensures these gaps are communicated to appropriate management. Identify opportunities for improvement and drive the implementation of initiatives and process changes with a focus on innovation. Act as a process expert and extends support to the operations team by sharing best practices amongst quality and the operations teams. Should be proficient in excel handling including the use of Excel's functions, features, and formulas to organize, analyze, and adjust data. Understanding Excel proficiency involves knowing its various tools, formulas, and functions. Your Key Accountabilities RTB focus. Primarily review transactions handled by operations team and their decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Review the rationale for the decision from pre-defined set of options. Share feedback for investigators/reviewers with the operational leads and share trends in errors. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorized purposes; actively safeguard sensitive and confidential information. CTB focus. Perform quality assurance on TSMO / AFC related change projects. Perform quality assurance on the parameter settings in the screening application and quality review of good guys approved and add to ensure the rules are adhered to. Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow ISO 20022 MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

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6 - 7 years

7 Lacs

Nalagarh

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Ensure contractor compliance with GMP and regulatory standards.Conduct audits and inspections of contractors, manufacturers, and suppliers.Review and approve Batch Records, SOPs, and quality documents. Required Candidate profile Manage deviations, CAPA, and ensure timely corrective actions. Liaise between contractors and internal teams for smooth operations.

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2 - 5 years

6 - 10 Lacs

Noida

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Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission- ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre- established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 2or more years of experience in pharmaceutical industry submission publishing or related technical skills c) Familiarity with FDA or EU regulations & guidelines To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/regulatory-submissions-publisher-4/

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8 - 13 years

10 - 15 Lacs

Hyderabad, Gaddapotharam

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Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.

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10 - 15 years

20 - 30 Lacs

Bengaluru, Delhi / NCR

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About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

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0 - 4 years

1 - 3 Lacs

Hyderabad

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Role & Responsibilities Assist in API/intermediate manufacturing as per SOPs. Monitor production processes and ensure GMP & quality compliance. Maintain batch records, logbooks, and related documentation. Handle raw materials, samples, and finished goods safely. Operate equipment such as reactors, centrifuges, dryers, and filters under supervision. Collaborate with QA, QC, and Engineering teams. Maintain workplace hygiene and follow EHS guidelines Preferred Candidate Profile B.Sc. / M.Sc. in Chemistry or related discipline. 04 years of experience in API or intermediate manufacturing (Freshers can apply). Willing to work in rotational shifts. Good knowledge of GMP, safety protocols, and documentation practices. Strong attention to detail, willingness to learn, and teamwork attitude.

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4 - 6 years

6 - 7 Lacs

Mumbai

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Corporate Quality Assurance is responsible for overseeing quality assurance programs across multiple shrimp processing facilities and ensuring compliance with food safety regulations, international standards, and company policies.

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6 - 11 years

14 - 24 Lacs

Tumkur

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Role & responsibilities Development and Implementation of new product Develop fried snack prototype Crunchier than existing profile, oil-efficient with optimal moisture content Understands the ingredient interactions and multiple frying techniques and methods to create simulation for different bill of material Improve product shelf life without impacting any existing product specifications. Flavour Formulation & Seasoning Optimization: Flavors consistency, adhesion, effectiveness post application and stability across shelf life Exploring different cutting, drying, and frying parameters for consistency Organize sensory panels to refine crispiness and flavour perception. Quality Management & Assurance Develop, implement, and maintain the companys Quality Management System (QMS) to ensure product quality meets the highest standards. Lead the design, execution, and monitoring of the companys quality control policies and procedures, including raw material inspection, in-process checks, and finished product testing. Ensure adherence to food safety standards and regulatory requirements (e.g., FDA, HACCP, GMP, local food safety regulations). Manage the risk of quality failures, food recalls, or production downtime related to quality issues, ensuring swift action is taken to address any challenges To work towards reducing the defects in process and customer complaints by taking proactive actions. Compliance, Documentation, Risk Management Maintain accurate records of quality testing, inspections, and audits, ensuring proper documentation for traceability and accountability. Liaise with external auditors and regulatory bodies, preparing the organization for inspections, audits, and certifications as required. Monitor and evaluate supplier performance, conduct supplier audits, work closely with suppliers for quality assurance Lead, mentor, and develop a team of quality assurance (QA) and quality control (QC) professionals, including training on best practices, industry standards, and regulatory requirements. Preferred candidate profile Masters degree in Food Science or Food Technology At least 10-12 years of experience in quality assurance or quality control within frying industry, with at least 5-7 years in a leadership role. Core Technical Expertise Frying, moisture and oil control, textural science in fried products, deep understanding of starch behaviour Flavour & Seasoning Formulation Strong background in flavour development, taste optimization and Flavors retention In-depth knowledge of food safety regulations (e.g., FDA, HACCP, GMP), quality systems, and relevant certifications Strong attention to detail and analytical skills Agile, proactive and results-driven with a focus on continuous improvement. High level of integrity and commitment to maintaining food safety standards. Ready to travel across manufacturing locations

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3 - 7 years

10 - 15 Lacs

Gurgaon

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Location : Gurgaon Designation : Senior Engineer: Requirement Management/JAMA Administrator Requirements : The Engineer will assist in the ongoing adaptation and deployment of new tools such as JAMA. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes and procedures, in relation to these software tools, for the quality system. We would love to have you on the team if you are a self-starter with a strong project organization skill set, have a firm grasp of the design control process common in regulated industries, and are motivated to work in a highly technical, fast-paced, and cross-functional environment. What you will do: Work independently with members of the business to define and document the scope of new development requirements in an Agile environment. A demonstrated ability to understand and articulate complex requirements Ability to critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs Ability to assess the impact of new requirements on all upstream and downstream applications, systems and processes Work with our management team to establish suitable processes to support administrative, development, and change management activities Document standards, guidelines, templates, and best practice procedures for both administrators and users of the system. Administrative owner of the tools such as Jama software requirements management tool Perform and own tasks including, but not limited to: User account maintenance Create filters and custom reports or dashboards for each project, as needed. Customize workflows for multiple projects and maintain configuration of the tools. Manage release cycles and validate the software tools. Upgrade, backup, and baseline the project folders within each software tool. Work closely with Quality engineering team for compliance. Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upwards Creative and analytical thinker with strong problem-solving skills Must demonstrate exceptional verbal and written communication skills Must demonstrate ability to communicate effectively at all levels of the organization Previous experience working in a SCRUM or Agile environment preferred Previous software development experience is preferred Minimum Qualifications (Required): Bachelors degree in computer science, Computer Engineering or related field is preferred and minimum of 2+ years of experience as a Software/Quality Engineer in a regulated industry. Preferred Qualifications (Strongly desired): Knowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITY Understanding of engineering lifecycle phases and design control processes is preferred. Proven ability to design and implement new processes and facilitate user adoption. Knowledge of Requirement Management and Test Management, Traceability. Experience validating third party tools to comply with Quality Management system and to follow FDA guidance is preferred. Experience with software and hardware defect tracking processes is preferred. Ability to communicate and work with external software vendors is preferred. Ability to work independently and manage priorities on multiple tasks is required. Excellent verbal and written communication skills is required. Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is preferred Interested candidates please reach on - HR Sonali - 8879984232 OR Share updated profile on sonali.patne@enlinkit.com

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7 - 12 years

12 - 22 Lacs

Ahmedabad

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Job Description Business Development Job Title: Manager / Sr. Manager/ AGM- Business Development Experience: 7– 15 Years Function: To handle Overall Business Development (Emerging & Semi Regulated Market) Job Responsibilities 1. Market Research and Strategy Development: Conduct research to identify new business opportunities and trends in regulated and emerging markets. Develop and implement strategic plans for market entry and expansion in existing or new market. Analyze competitor activities, market trends, and regulatory landscapes to adapt business strategies. 2. Business Development: Identify and build relationships with potential business partners, distributors, and clients in assigned markets. Negotiate and finalize agreements, ensuring mutual benefits and compliance with company policies. Maintain strong relationships with existing partners to ensure continued growth and collaboration. 3. Regulatory Compliance: Ensure business activities align with pharmaceutical regulations (FDA, EMA, local market rules). Collaborate with regulatory teams to navigate market entry requirements. 4. Client Relationship Management : Build and maintain strong relationships with key clients, partners, and stakeholders in international markets. Collaborate with clients to understand their needs and provide tailored solutions. 5. Team Leadership and Management : Supervise and manage a team of Business Development Managers, ensuring alignment with organizational goals. Provide mentorship, training, and support to team members to enhance their performance and skill sets. 6. Business Performance Tracking and Communication: Monitor sales performance, market share, and ROI in the assigned markets. Prepare periodic reports to provide insights and recommendations to senior management. Facilitate effective communication between the team and other departments. 7. Operational Oversight : Ensure smooth execution of business development activities and adherence to timelines. Oversee contract negotiations, proposal submissions, and closing deals. Interested candidates are can apply on Darpana: 9978604075 or can email me on darpana@upman.in

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5 - 8 years

3 - 7 Lacs

Pune

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Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

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2 - 6 years

10 - 14 Lacs

Mumbai

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About The Role : Job TitleRegulatory Advisory Analyst Corporate TitleNCT LocationMumbai, India Role Description The CRM & PBCRO Regulatory Adherence at Deutsche Bank ensures a CRM-wide discipline for the assessment and analysis of consultations and new rules and regulations and is playing a key role in leading, supporting and validating regulatory driven changes initiatives impacting our credit systems and processes. Your role will primarily be focussed on global regulations impacting all international credit portfolios in Corporates & Investment Bank (CIB) as well as domestically in Germany (PB Germany) and in the International Private bank (IPB). Members of the team are located in Frankfurt, Bonn und Mumbai. This position is within Regulatory Adherence in Mumbai servicing global locations. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities You are responsible for Regulatory Adherence activities along the regulatory life-cycle related to Credit Risk including tracking and review of incoming new rules & regulations and consultations affecting Credit Risk. You will support the performance of global impact assessments and tracking of potential gaps resulting in remediation- and corresponding project/ change activities, dependent on materiality of the regulations in conjunction with a Senior Analyst. You identify and analyse regulatory trends and supervisors priority topics and prepare bankwide advocacy work including project support in key regulatory initiatives (i.e. CRR; MaRisk) with corresponding change initiatives. You will support coordination and Senior Regulatory Leads in regulatory driven changes initiatives impacting our (IT) systems and processes as part of the adherence analysis and advocacy work, i.e. joining project teams and working groups to drive quality standards and control frameworks to meet new regulatory requirements. You will actively coordinate stakeholders feedback of the areas impacted including coordination of Subject Matter Experts in different credit areas. You are responsible for reporting tracking items, and preparation of Management presentations. Your skills and experience A Masters degree or the equivalent experience or qualifications Min 3yrs Background in a Risk function within the financial services industry. Credit risk management knowledge including experience in credit process and/or methodologies and/ or credit portfolio management appreciated Regulatory knowledge with focus on credit risk relevant or related regulations. Experience in project and change management with good analytical and conceptual skills with the ability to solve complex problems, develop innovative and structured solutions and ability to see the broader picture front-to-back and assess dependencies and interdependencies Very good communication and social skills with excellent client and service focus, as well as confidence in working with decision-makers from all levels of the organisation being a good team player Fluent in Microsoft Office tools Fluent in English How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.

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5 - 10 years

5 - 10 Lacs

Bengaluru

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IT Security - Team Lead - Bengaluru - Work from office Proven experience (5+ years) in IT security with team lead role experience. Deep knowledge of Security Technologies (like., Active Directory, Endpoint Protection, Web Gateway, DLP, firewalls, SIEM, IDS/IPS, Encryption, PAM, WAF, Vulnerability Assessment and Patch Management). Experience with Vulnerability Scanning Tools and Risk Assessment methodologies. Lead and mentor a team of Cyber Security Professionals, ensuring a high level of motivation, performance and continuous professional development. Manage Team workload, prioritize tasks and allocate resources effectively to meet security goals. Oversee day-to-day security operations, including security monitoring, incident detection and incident response. Analyse security logs and data to identify threats, vulnerabilities and anomalies and escalate issues as needed. Collaborate with IT and Development teams to integrate Security Best Practices into system architecture, network design and application development. Continuously evaluate and improve the company's security policies, procedures and controls. Foster a collaborative environment, providing support and guidance to junior and mid-level team members. Provide regular reports to Senior Management and Stakeholders on the Security Reports & Posture of the organization. Maintain clear and effective communication during security incidents and with other departments, ensuring timely resolution of issues. Conduct Security Awareness training for employees to promote security best practices. Ensure compliance with relevant industry regulations (e.g., GDPR, HIPAA, NIST, FDA). Stay current with the latest trends, tools and technologies in cyber security and bring innovation to the security program. Coordination with Vendor for Improvements and Deployment of new technology. ********************************************************************************* If interested with this opportunity, Kindly - do share your updated Resume along with below required details to devaraj.v@valuepointsystems.com OR WhatsApp to 8867682884 Notice Period: Total Experience: Relevant Experience: Current Location: Preferred Location: Current CTC: Expected CTC:

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2 - 7 years

2 - 5 Lacs

Bengaluru

Remote

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Role & responsibilities Regulatory Affairs Associate I Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established “CLIENT”procedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements – Education and Experience Relevant qualification and/or experience in science Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of “CLIENT”business and processes Some knowledge of “CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Reporting Relationship Direct Reports – None Indirect Reports – None Interested candidate may reach @ 9845914559 or drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

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4 - 9 years

0 Lacs

Hyderabad

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Skills & Keywords: Regulatory Affairs | RA Compliance | Medical Devices | Pharma Regulatory | FDA | CE Marking | ISO 13485 | Clinical Research | Quality Assurance | Risk Management

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2 - 6 years

7 - 10 Lacs

Bangalore Rural, Hyderabad, Mumbai (All Areas)

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Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

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4 - 9 years

22 - 27 Lacs

Bengaluru

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Job Title Software Technologist Job Description Analyses, designs, tests, codes, secures, debugs, modifies, deploys, integrates and maintains (system) software enhancements, test environment and/or new software. Uses state-of-the-art technologies and practices. Interacts with users / product owners to define / adjust requirements and/or necessary modifications. Keeps abreast of technical developments and practices in own field through literature, courses/trainings, technical contacts, and competitive environment. Applies agile software development methods as a member of agile teams. To succeed in this role, you should have the following skills and experience. BE/BTech/MCA/MTech with 4-9 Years of exp in Embedded Systems As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct others and architect solutions. Software design and development in embedded applications using C/C++ is required; C# and Python is preferred. Experience in RTOS. Experience in ARM architecture, ARM microcontrollers. Working knowledge in usb, ethernet, I2C,SPI, UART, Timers, etc. Experience in software development in medical industry or highly regulated industry. Experience with IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards is highly preferred Experience in Agile SW Development practices. Experience in scaled agile framework (SAFe) is preferred Demonstrated experience working with real time operating systems. ThreadX is required, FreeRTOS is preferred Knowledge and application of the following standards and interfaces is preferred As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct others and architect solutions. Skill expectations: Software design and development in embedded applications using C/C++ is required. Experience in RTOS. Experience in ARM architecture, ARM microcontrollers. Working knowledge in usb, ethernet, I2C, SPI, UART, Timers, etc. Experience in software development in medical industry or highly regulated industry. Experience with IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards is highly preferred Experience in Agile SW Development practices. Experience in scaled agile framework (SAFe) is preferred Demonstrated experience working with real time operating systems.

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5 - 10 years

8 - 12 Lacs

Hyderabad

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Group Purpose Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization. Job Summary Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence. Key Activities Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback Effectively communicates regulatory requirements to Regulatory Affairs staff Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Works with limited supervision according to predefined regulatory intelligence workplans Applies tools and systems to deliver agreed intelligence objectives Communicates progress and escalates issues impacting delivery of intelligence outputs Provides suggestions for improvement of processes, systems and tools employed within the function. Knowledge and Skills Basic: Regulatory intelligence monitoring, analyzing, and interpreting global regulatory developments to ensure compliance and inform strategic decision-making. Knowledge of regulatory agency guidelines and procedures (major and non-major markets) Knowledge of regulatory intelligence systems and platforms Understanding and application of aspects of global and local regulatory process Project management skills Presentation and interpersonal communication skills Preferred: Global Regulatory Intelligence monitoring experience Education and Experience (basic) Doctorate degree, OR Master’s degree and 3 years of directly related experience. OR Bachelor’s degree and 5 years of directly related experience, OR Associate’s degree and 10 years of directly related experience Education and Experience (preferred) A bachelor's degree in life sciences or a related field; advanced degrees may be preferred. A minimum of 5 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role within the pharmaceutical, biotechnology, or medical device industries. In-depth knowledge of global regulatory frameworks and guidelines, such as those from the FDA, EMA, and other health authorities. Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights. Excellent communication skills, both written and verbal, to effectively present information to diverse audiences. Proficiency with regulatory intelligence databases and software tools.

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8 - 10 years

12 - 15 Lacs

Mumbai, Mumbai (All Areas)

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- Must have good knowledge of Regulatory Submissions and Research - Must be familiarity with chemical industry specific regulations and guidelines. - Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies Required Candidate profile - Ensure company products with relevant regulatory requirements such as USFDA, FDA, EMA, and local regulations. - Stay up-to-date with changing regulatory requirement to internal stakeholders.

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6 - 8 years

4 - 5 Lacs

Bengaluru

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Role & responsibilities Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements, industry standards, and customer expectations. Establish and enforce quality standards, policies, and procedures across all product lifecycle stages, from design and development to manufacturing and delivery. Lead and coordinate quality audits, inspections, and assessments to identify non-conformities, root causes, and opportunities for improvement. Analyze quality data, metrics, and trends to monitor process performance, identify areas of concern, and drive corrective and preventive actions. Collaborate with cross-functional teams, including engineering, production, and supply chain to address quality issues, implement corrective actions, and prevent recurrence. Conduct risk assessments and failure mode and effects analysis (FMEA) to identify potential quality risks, priorities mitigation efforts, and ensure product safety and reliability. Lead and participate in continuous improvement initiatives, lean Six Sigma projects, and quality improvement teams to optimize processes and reduce waste. Develop and deliver training programs on quality management principles, techniques, and tools to enhance awareness and competency across the organization. Serve as a liaison with customers, suppliers, and regulatory agencies on quality-related matters, ensuring timely resolution of quality issues and effective communication of quality requirements. Provide leadership and mentorship to quality assurance teams, fostering a culture of excellence, accountability, and continuous learning. Preferred candidate profile Bachelors degree in Engineering, Quality Management, or a related field. Masters degree preferred. Minimum of 6 to 8 years of experience in quality assurance, quality engineering, or related roles, preferably in [industry or specific domain]. Strong understanding of quality management principles, standards (e.g., ISO 9001), and regulatory requirements (e.g., FDA, EU MDR). Proven experience in implementing and maintaining quality management systems (QMS) and leading quality audits and inspections. Excellent analytical and problem-solving skills with the ability to analyze complex quality issues, identify root causes, and implement effective corrective actions. Strong communication and interpersonal skills with the ability to collaborate effectively with cross functional teams, stakeholders, and customers. Detail-oriented with a focus on accuracy and precision in quality assurance processes and documentation. Strong leadership and management abilities with a track record of successfully leading quality assurance teams and driving continuous improvement initiatives. Certification in quality management (e.g., ASQ Certified Quality Engineer, Six Sigma Black Belt) is a plus. Send your resumes to hr@veerya.biz call : 8867229996 Perks and benefits

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