200 Usfda Jobs - Page 5

Role & responsibilities Prepare and Review SOPs and Guideline for DQA. Formulate Documentation Process for the Key divisions of SRD and ARD. Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists. Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirements Review process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies. Handle Vendor Qualifications for KSM/KRM, Solvents etc. Ensure Regulatory compliance as per USFDA and other such regulatory bodies. Support and handle all aspects pertaining to new product development patent filing, license approvals etc Impart training to all employees on SOPs/Safety. Support on Onboarding on new employees joining the organization Responsible for assessing the impact, review and closure of change control requests and deviations. Responsible for CAPA implementations, verifications of and effectiveness. Preferred candidate profile Bachelors or Masters degree in Pharmaceutical Sciences, Chemistry, or related field. Minimum 5-8 years of experience in Quality Assurance, with at least 2 years in a supervisory role in the pharmaceutical industry, specifically with API products. In-depth knowledge of GMP, ICH guidelines, FDA, EMA regulations, and quality systems. Proven experience in conducting internal and external audits, and leading regulatory inspections. Strong understanding of the API development and manufacturing process. Ability to manage cross-functional teams and interact with senior management

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. Validation experience and expertise in manufacturing, QC, Investigation, CAPA, Deviati

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in

Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe Exposure to Export Regulatory Market Quality and speedy response to the Regulatory agencies queries and Customer queries. Required Candidate profile Review and submission to drug listing (Label) of our API to US-FDA Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry

MANAGER QC : Expertise in Hplc,Gc,Ms etc & regulatory req FDA ICH Guidelines. 8-15 yrs exp,12-15 lacs pa Sr Analyst: Hplc, Gc, Ms etc, Method validation etc,5-10 yrs exp,6-10 lacs pa Analyst: Hplc Gc Ms etc, 3-5 yrs exp, 4-6 lacs pa Freshers: 3lacs pa.

Global Calcium is looking for an experienced Manager - Regulatory Affairs with expertise in DMF & CEP filings and global regulatory submissions. If you have a passion for ensuring regulatory compliance and working with global health authorities, we want to hear from you! Key Responsibilities: DMF & CEP Filings: Prepare, review, and submit Drug Master Files (DMFs) in eCTD/NeeS format for USFDA, EU, and other markets. Handle amendments, annual updates, and regulatory deficiency responses. Regulatory Submissions & Compliance: Collaborate with R&D, Quality, and Manufacturing teams to compile technical data while ensuring adherence to GDP & global regulatory guidelines. Regulatory Communication & Strategy: Act as a liaison with regulatory authorities (USFDA, EU-GMP, TGA, etc.) and provide guidance on compliance strategies. Audits & Documentation: Support regulatory inspections & audits, ensure all regulatory documents are updated, and train internal teams on submission processes. Qualifications & Skills: Education: M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences, Regulatory Affairs, or Chemistry. Experience: 08+ years in Regulatory Affairs, with expertise in DMF & CEP filings. Key Skills: Regulatory guidelines, documentation, stakeholder management, analytical thinking, and communication skills. Why Join Us? Work in a globally recognized organization in the pharmaceutical industry. Contribute to key regulatory approvals across international markets. Collaborate with a team of experts in a dynamic environment. Interested candidates can send their resumes to: ramakrishnar.r@globalcalciumpharma.com Know someone who might be a great fit? Share this opportunity!

Monitor and assess the safety of pharmaceutical products through the collection and analysis of adverse event reports. Ensure compliance with regulatory requirements related to pharmacovigilance. Prepare and submit reports to regulatory authorities regarding product safety. Collaborate with internal teams to develop risk management strategies for pharmaceutical products. Provide training and guidance to staff on pharmacovigilance practices and policies. Maintain up-to-date knowledge of industry trends and regulatory changes.

Lead US ANDA submission processes, ensuring compliance with FDA requirements. Oversee end-to-end project management for ANDA filings, from conceptualization to commercialization. Identify and evaluate reliable API suppliers for US market projects

Greetings!!!! We are seeking for a QA Manager role - for Global API Manufacturing company at Chennai. Responsibilities: Responsible for Quality of products manufactured & QMS requirement at manufacturing site • Perform Gap analysis at regular interval to identify any gaps in quality system with respect to change in SOP, updating in pharmacopeia, change in any regulatory guidelines etc, and to inform Head QA to prepare & implement action plan as per guidance of Head QA. • Follow & establishment good documentation and filing system for easy retrieval & maintenance of all quality records Monitor Change control management and review the monthly data on change control status. Review and approval of Change controls, documentation and associated CAPAs and Provide Change control status for site quality management review meeting. • Management of Deviations and CAPA investigations and Periodic review of CAPA status with all concerned for timely closure of the same. • Handling of Out of specification, out of trend results and Customer complaints logging, investigation and Ensure timely closure of CAPA for the same. • Preparation of Annual product reports and Vendor Qualification of Raw Materials & Packing Materials with respect to Vendor Questionnaire Verification, Vendor Audit and Compliance Report Verification prior to Approval. • Review of all validation protocols and reports like process validation, cleaning validation, purified water, WFI validation, & Equipment Qualifications. • Review of online batch records review for all stages of manufacturing & packing activities. • Meeting all the delivery schedules for the products as committed in the Plan. Co-ordination with Research team, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan. • Active participation for timely installation, commissioning and validation of all the equipments and processes in the API Manufacturing facility. • Maintaining and up keeping the area as per the cGMP and Regulatory requirements and putting continuous efforts for improvement in quality and Productivity. • Co-ordination during the execution of Validation batches & process stabilization activities of various APIs & Intermediates. • Co-ordination in Quality Risk Management with various departments and Involving in HAZOP studies of various products to address the EHS issues before to Adopting in plants with safety department. • To ensure implementation and propagation of all EHS norms so as to create safe working Environment.Compliance to 5S and OE documentation. Tamil Speaking is Must Interested candidates kindly share your updated cv to uma@bvrpc.com

Oversee the preparation, review, and submission of regulatory filings, including DMFs, ANDAs CTD submissions, and other relevant documentation. Document review Preparation and submission of DMF to various countries. Review & verification of BPCRs , PVP/PVR and method validation reports. Regularly updating and maintaining regulatory work sheets for monthly management review. Review and compiling vendor Qualification Documents and ROS etc. Review and compiling of CMC documents. Gathering and reviewing documents received from QA and other departments. Compilation of technical Data Packages, Quality Overall Summary & Open Part DMFs. Preparing US DMFs for USFDA, ASMF, CEP etc. Preparing Customer query response to AP/OP DMfs & TDPs raised by various customers. Preparing Applicant Part/ Open Part DMFs to various Customers. Preparation of LOAs LOEs, others declarations & commitment based on customers.

Roles and Responsibilities: 1. Managing maintenance for OSD utilities, plant equipment, electrical systems, instrumentation, calibration, HVAC, civil design, and overseeing overall site engineering operations, with expertise in handling large volume projects. 2. Evaluate instrument/equipment/calibration points in the SAP system for calibration, preventive maintenance, and breakdown maintenance. 3. Implementing energy conservation strategies for power and fuel cost reduction 4. Achieving optimal plant machinery utilization through the development and implementation of new technologies. 5. Coordinating with corporate engineering for the implementation of utility modification, renovation, and cost reduction projects. 6. Reviewing the maintenance of ASRS and machinery 7. Managing Trackwise, LMS, SAP, Documentum, and EDMS software. 8. Monitoring and maintaining ETP/MEE. 9. Coordinating with government bodies related to Boiler, PCC, DNH Power Distribution Corporation Limited, etc. 10. Implementing cGMP practices, GEP practices, and introducing energy-saving initiatives. 11. Reviewing and approving the investigation, root cause identification, and CAPA derivation for system failures, out-of-specification observations, change control, and action items through the Trackwise (QMS) system. 12. Ensuring compliance with internal audits, external audits, and addressing visit observations. 13. Coordinating with corporate engineering for monthly and quarterly reports. 14. Ensuring compliance with all EHS (Environment, Health, and Safety) requirements 15. Reviewing the operation of EMS/BMS systems. 16. Ensuring vendor services align with AMC schedules. Education : B.Tech (Mechanical) Preferred candidate should have a background exclusively in the Pharma Industry, with specific experience in Oral Solid Facility operations. 2. Preferred candidate should have experience in managing engineering and maintenance activities for a Large Volume block. 3. Desired candidate should possess exposure to GMP Audits Experience : 15 to 18 Years of experience Location : Paonta

Coordinate, compile regulatory documentation of filing activities/post approval changes for submission to regulatory authorities Approval with all relevant regulators USFDA Formulate RA standards, policies to ensure that regulatory compliance Required Candidate profile Must be from Life Sciences, have experience with USFDA, Compliance, ISO 13485, basic requirements of EU guidelines, medical device related regulations its requirements for approval, change management

Domain Expert Pharmaceutical Microbiology Professional who can analyse the business needs with respect to automation in pharmaceutical microbiology workflow, then designs, implements, and configures software solutions to optimize their business processes by translating business requirements into functional specifications. Key responsibilities: • Requirements gathering: Conduct in-depth analysis of client business processes to understand their needs, automation possibilities and areas for improvements • Solution design: Translate business requirements into functional specifications, designing system configurations to meet those needs. • System implementation: Configure and customize the chosen software application based on the defined specifications. • User training: Develop and deliver training materials and sessions to end-users on how to effectively utilize the new system. • Client relationship management: Build strong relationships with clients, manage expectations, and provide ongoing support. Skills and Qualifications: • Microbiology: Ability to analyse the growth and behaviour patterns of all forms of microorganisms. Microbiologist should be able to classify microorganisms found in collected specimens. They should be able to quantify bacterial and fungal colonies • Workflow Management Software Strong understanding of Software for managing the workflow for environment monitoring and quality control in pharmaceutical manufacturing. • Risk Assessment Knowledge of aseptic process risk assessment and evaluation of sampling locations for environment .Monitoring. Understanding of the risk assessment process for airflow and air classification based on aseptic processes like filling, filtration, lyophilization and capping • Qualification and Validation Understanding of the qualification protocol and smoke study protocol. • Media Fill Understanding of media fill process and ability to monitor aseptic practices during routine production and media fill runs • Monitoring Understanding of the aseptic operations, environmental monitoring activity for viable particle count (VPC) and non-viable particle count (NVPC). Understanding of various sampling methods and practices (personal monitoring, settle plate, surface sampling, airflow monitoring) testing methods, utility monitoring and non-EM sampling methods. • Regulatory Principles of Guidelines: Exposure to principles and practices associated with PDA, USFDA, Warning letters related to aseptic practices and sterility assurance, EU Guidelines, GAMP etc. • Process quality and documentation Knowledge about the SOPs on EM monitoring activities and quality control in used in pharmaceutical manufacturing set ups. Ability to prepare SOPs and study protocols.

/ Responsibilities Designing of HVAC Systems & Clean Room for Pharmaceutical (Sterile/non sterile, inject able, tablet, capsule, Betalactum, liquid mfg. plants), Biotech Projects, (as per the GMP, WHO, US-FDA, ASHRAE, SMACANA, etc guidelines. Heat load Calculations and HVAC Equipments selections like chillers, cooling towers, AHU, chilled water control accessories Etc. Detailing and review of various HVAC drawing like Air flow diagram, Pr. Zoning, system zoning, equipment zoning layouts, Ducting layouts, RCP layouts, CHW & HW P&ID, HVAC Piping layouts etc. . Designing of clean rooms as per class 1,00,000 class 10,000, class 1000. Etc. knowledge of Modular partitions & False ceiling etc. Preparation of Technical specification and Datasheets of HVAC High side & Low side equipments. Validation & Documentation of HVAC system such as DQ, IQ, OQ, PQ. Interface with equipment suppliers / vendors to discuss design issues and resolve problems. Qualification BE Mechanical Relevant Experience 4 to 6 Years of relevant experience in Pharmaceutical/API projects Location Thane

Positions 1) Technology Transfer Scientist (FRD) / 2- 6 years of experience 2) Documentation Lead (FRD)/ 3- 8 years of experience 3) Formulation Development Scientist/ 2- 10 years of experience 4) FRD Injectables / 2- 8 years of experience

Walkin at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned, If any of the requirement is matching your current job profile, kindly walk-in with your latest resume. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable) - (Officer / Senior Officer / Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY ASSURANCE (QMS / Compliance / Documentation/ Validation & Qualification/OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Engineering: Instrumentation / QMS (Senior Executive / Executive / Senior Officer) Experience - 03 to 09 Years Qualification BE / B tech with relevant functional experience in Calibration / Instrumentation / QMS activities Injectable - Manufacturing & Packing & Visual Inspection (Senior Executive / Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Packing / Visual inspection / QMS activities OSD Manufacturing & Packing ( Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 29th June 2024, 09:30 Hrs to 15:00 Hrs ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in. Perks and benefits

Role & responsibilities Job description Ensure that a company's products comply with the regulations of the regions. Keep up to date with national and international legislation, guidelines and customer practices Respond to queries from Centre for Veterinary Medicines (CVM). Collect, collate and evaluate scientific data from FR&D, AR&D and DQA. Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site. Prepare submissions of licence variations and renewals to strict deadlines as per CVM. Monitor and set timelines for licence variations and renewal approvals Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product Review company practices and provide advice on changes to systems if any. Liaise with manager, and make presentations to, regulatory authorities, if any. Negotiate with regulatory authorities for marketing authorisation Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D. Review the data and check for its alignment and compliance from regulatory point of view as per CVM. Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance. Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.

Job Title: Manager/Senior Manager QA Regulatory Affairs Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 8-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: M.Sc in Biotechnology, Microbiology, or a related field Bachelor’s or Master’s in Pharmacy Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager/Senior Manager – QA Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines : Extensive knowledge of global regulatory requirements (e.g., FDA , EMA , WHO ) with specific expertise in vaccines , injectables , and sterile product manufacturing . Regulatory Submissions & Documentation Expertise : Strong experience in preparing regulatory dossiers and eCTD submissions in compliance with regulatory standards for vaccines and sterile products . Audit & Inspection Management : Hands-on experience managing CDSCO and EU GMP audits, including preparing for inspections, addressing findings, and implementing corrective actions. Quality Management System (QMS) Oversight : Expertise in implementing and maintaining QMS in compliance with GxP , FDA , EU , and WHO guidelines, ensuring product quality and regulatory compliance. Risk Management & Mitigation : Proven ability to conduct regulatory risk assessments and implement mitigation strategies to prevent non-compliance and product issues. Strong Leadership & Project Management : Demonstrated ability to lead cross-functional teams, manage multiple projects, and meet regulatory deadlines while ensuring alignment with quality and regulatory expectations. Corrective & Preventive Action (CAPA) Implementation : Experience in managing CAPA processes, addressing non-compliance issues, and ensuring the effective resolution of audit findings and regulatory observations. Excellent Communication Skills : Strong verbal and written communication skills, with the ability to liaise with internal teams, regulatory bodies, and external stakeholders in a professional and clear manner. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries

Role & responsibilities: Responsible for all Deficiency management of US Market Skill to compile & review ANDAs & their Deficiency responses. Experience of working on IND / 505(b)(2) / Innovations projects for US market. Good analytical and formulation understandings of various dosage forms. Sound knowledge of Regulatory Science and Regulatory Intelligence. Thorough understanding of US ANDAs / GDUFA / ICH guidance. To provide support to cross functional teams to ensure quality and timely submission of the NDA/ANDA/Def. responses. Preferred candidate profile : Must have experience of IRA US market more than 2 years. Critical thinking ability, problem solving skill, regulatory writing skill, and communication skills are very much desired Ready to work at Ahmedabad location. Work from Office only.

Labour and Employment Law Legal Team Associate Manager / Manager Description About Entity: Corporate Functions"including Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutions-- powers Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Job description: Labour & Employment Counsel Associate Manager Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, Accenture offers Strategy and Consulting, Technology and Operations services and Accenture Song"all powered by the world's largest network of Advanced Technology and Intelligent Operations centres. Accenture India has operations in 14 cities across India and have more than 300k employees spread across these locations. Requirement: We are looking for 2 lawyer for position of Associate Manager (equivalent to a Deputy Manager in industry parlance) in the Employment Law (India) Legal Group Reporting will be to Senior Manager / Associate Director [Legal] Employment Law which is a part of Operations, Regulatory and Ethics (CORE) Legal, supports a broad portfolio and supports the Delivery Centres, in end-to-end operations. Internal clients range from Employee Relations, HR, Recruitment, Workplace, Global Asset Protection (GAP), Marketing and Communication (Marcom), and Government Relations. Role Description: This role is broad and could involve providing advice on various facets of legal and employment areas and demands an understanding of Indian labour laws, laws relating to investigations (misconduct, POSH and others), and court proceedings etc. Focus for the current position is as follows: Role Description: Advisory Services: Provide legal guidance on employment-related issues in India, including hiring practices, employment contracts, misconduct, discrimination, harassment, employee benefits, termination procedures etc. Proactively assess and mitigate employment legal risks. Employment Disputes and Litigation: Manage employment-related disputes, claims, and litigation in tribunals and courts, including wrongful termination, discrimination claims, and wage disputes. Collaborate with external legal counsel to strategize and achieve optimal outcomes. Legal Drafting: Prepare written statements and responses to claims, conduct comprehensive legal research to support case strategies, and stay abreast of recent case laws and legal precedents in labour and employment law. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Policy review: Collaborate with stakeholders to develop, review, and implement employment policies and procedures that comply with local laws and align with the organization's values. Regulatory Monitoring: Monitor changes in employment laws and regulations, assess their impact on the organization, and recommend proactive measures to ensure compliance and mitigate potential risks. Labour Compliance: Ensure adherence to labour laws and regulations, including the Shops and Establishments Act. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Key Skills: Review employee matters, analyse and asses possible and suggest mitigations measures. Court experience and proficiency in drafting legal documents and court submissions Strong legal research and analytical skills with in-depth knowledge of Indian labour laws and regulations Clear communication and interpersonal skills High attention to detail and exceptional organizational skills. Qualifications Education and Experience Requirements Required LLB 6 + years relevant work experience

Role & responsibilities Senior executiveIssue of BPR's, Validations,Qualifications,Change control, Handling Deviations Preferred candidate profile should be from API background Perks and benefits Best In industry

Overview Shure is a global leader in professional audio electronics with a history of product innovation spanning over 90 years. The Shure Hyderabad location has been operational since June 2019. W e are looking for talented professionals who have experience in the SEZ compliance area. This position is a part of the Finance team at Shure India. Responsibilities Well versed with SEZ Rules , Regulations and customs regulation Should have exposure to de-bonding, Imports, DTA, Temporarily Removal of goods and other allied matters in SEZ Well versed of SEZ online portal Exposure to all compliances related to SEZ and STPI units viz., MPR, QPR, APR, Softex, Endorsement of Invoices, DSPF etc. Collation of details from relevant teams for preparation of returns/ submissions/ replies to SEZ STPI authorities for various units across India Responsible for representations/liaising with SEZ/STPI Authorities for various matters and obtain necessary approvals Assistance in audits Liasioning with Bankers for clearing the BOE’s Ensuring the invoices are in compliance with the SEZ norms Maintaining the documentation Maintaining the Fixed Asset Register Qualifications Bachelor’s Degree in Commerce or MBA with experience of working in multi national companies in similar role. Experience is minimum 3Years. WHO WE ARE. Shure’s mission is to be the most trusted audio brand worldwide – and for nearly a century, our Core Values have aligned us to be just that. Founded in 1925, we are a leading global manufacturer of audio equipment known for quality, reliability, and durability. We engineer microphones, headphones, wireless audio systems, conferencing systems, and more. And quality doesn’t stop at our products. Our talented teams strive for perfection and innovate every chance they get. We offer an Associate-first culture, flexible work arrangements, and opportunity for all. Shure is headquartered in United States. We have more than 35 regional sales offices, engineering hubs, and manufacturing facilities throughout the Americas, EMEA, and Asia. THE MIX MATTERS Don’t check off every box in the job requirements? No problem! We recognize that every professional journey is unique and are committed to providing an equitable candidate experience for all prospective Shure Associates. If you’re excited about this role, believe you’ve got the skills to be successful, and share our passion for creating an inclusive, diverse, equitable, and accessible work environment, then apply! #LI-HYBRID

Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Prepare, review, and maintain Standard Operating Procedures, Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR), Process Validation Protocol, Process Validation Report, Stability and Specifications and Standard Testing Procedure.