200 Usfda Jobs - Page 3

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Apollo Pipes 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

Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;; Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL . Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Walk In Drive For Quality Control Department In Formulation Division @ Vizag Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- Hotel Cygnett Inn Ramachandra , 31-2-4/5, NH16, opp. All India Radio Station, Kurmannapalem, Visakhapatnam, Andhra Pradesh 530046 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To maintain the BMRs and other log books in respective area as per cGMP and SOP. Responsible for timely completion of calibrations and validations in coordination with Eng. and QA related to respective areas. Responsible for the Operation and cleaning of Automatic visual inspection. Responsible to perform visual inspection of the products /media filled vials as per the sop. Operation and cleaning lux mater, visual inspection table. Operation and cleaning of glove integrity and filter integrity testers Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Responsible for cleaning and storage of all the filling machine accessories and change parts Operation and cleaning of table mounted LAF and Ceiling mounted LAF Operation and cleaning of steam sterilizer and HPHV steam sterilizer. Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for ensuring garments washing, drying and folding activities Timely completion of SOPs Training and On the job trainings related to respective area. Responsible for Maintenance of cleaning in in External washing and vial washing area & Depyrogenation tunnel areas and f Component preparation and sterilization area. Cleaning and sanitization of drain points in External washing and Vial washing & Depyrogenation tunnel areas and f Component preparation and sterilization area Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations Since 2011, our mission hasnt changed "” were here to stop breaches, and weve redefined modern security with the worlds most advanced AI-native platform Our customers span all industries, and they count on CrowdStrike to keep their businesses running, their communities safe and their lives moving forward Were also a mission-driven company We cultivate a culture that gives every CrowdStriker both the flexibility and autonomy to own their careers Were always looking to add talented CrowdStrikers to the team who have limitless passion, a relentless focus on innovation and a fanatical commitment to our customers, our community and each other Ready to join a mission that mattersThe future of cybersecurity starts with you. About The Role CrowdStrike is looking for Analyst- Global Payroll as our payroll team is expanding This position is designed for a strong team contributor, analytically strong, numbers driven, detail-oriented Payroll leader to support our International Payroll team in our SSC-Pune, India. A strong team player and willing to go extra mile to ensure our Global payrolls/Projects are delivered timely with highest accuracy This is a fast-paced, dynamic role and you will take on interesting and challenging responsibilities as our organization continues to grow in both size and complexity This role will be a key part of the successful growth of the payroll team and located in our office in Pune, India. What You'll Do Payroll Management: Gather information required to perform payroll calculation. Calculate base salary, allowances and other components of payroll in accordance with organizational policies and procedures. Input data into payroll systems to support processing and calculating activities. Process routine payroll and related administration reports. Quality Management Review performance of software or hardware products or service components. Perform audits under stipulated conditions and highlight major incidents. Inspect Key deliverables/collaterals through toll gates. Ensure 100% compliance to internal processes and standards. Operational / Process Excellence Review current processes and report anomalies at a regular interval. Document and present feedback received through different channels. Suggest changes in input or output metrices for a process. Maintain trackers for all processes and draw actionable insights from the data. Governance & Compliance Follow legislation, policies, procedures, guidelines relevant to day-to-day operations as outlined by corporate governance policies. Vendor Management Connect with vendor monthly to discuss the ongoing issues and plan payrolls. Stakeholders Management Identify key stakeholders and the organization's relationship with them. Identify stakeholder needs, positions, and interests. Coordinate basic activities/and processes with stakeholders on a day-to-day basis. Apply knowledge of the Organization's position to respond to simple and complex queries from stakeholders. What Youll Need Bachelors Degree and or equivalent degree Minimum 3-5 years of experience with EMEA/APAC with a high-growth, fast paced environment Strong understanding of payroll systems, payroll statutory, earnings and deduction codes, GL mapping. Knowledge of ESPP, STOCK, RSU is a plus. Ability to handle multiple country payrolls and be proactive in a fast-paced environment with changing priorities. Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company. Individuals must be organized, analytical, and detail oriented. Experience with the following systems is preferredWorkday, NetSuite, SQL/SAP based payroll system. Work Location Kharadi, Pune (Work from Office) Shift Timing2:00 PM to 11:00 PM IST Benefits Of Working At CrowdStrike Remote-friendly and flexible work culture Market leader in compensation and equity awards Comprehensive physical and mental wellness programs Competitive vacation and holidays for recharge Paid parental and adoption leaves Professional development opportunities for all employees regardless of level or role s, geographic neighbourhood groups and volunteer opportunities to build connections Vibrant office culture with world class amenities Great Place to Work Certified„¢ across the globe CrowdStrike is proud to be an equal opportunity employer We are committed to fostering a culture of belonging where everyone is valued for who they are and empowered to succeed We support veterans and individuals with disabilities through our affirmative action program. CrowdStrike is committed to providing equal employment opportunity for all employees and applicants for employment The Company does not discriminate in employment opportunities or practices on the basis of race, color, creed, ethnicity, religion, sex (including pregnancy or pregnancy-related medical conditions), sexual orientation, gender identity, marital or family status, veteran status, age, national origin, ancestry, physical disability (including HIV and AIDS), mental disability, medical condition, genetic information, membership or activity in a local human rights commission, status with regard to public assistance, or any other characteristic protected by law We base all employment decisions--including recruitment, selection, training, compensation, benefits, discipline, promotions, transfers, lay-offs, return from lay-off, terminations and social/recreational programs--on valid job requirements. If you need assistance accessing or reviewing the information on this website or need help submitting an application for employment or requesting an accommodation, please contact us at recruiting@crowdstrike.com for further assistance. Show more Show less

To head the total QC function for the Company's India operations and will cover the groups personal care. It will involve the leading and managing of a large team, while building a systemised and rigorous QC for FG as well as packaging materials. Required Candidate profile Knowledge of QMS such as QMS-9001, GMP-22716 Must have be from perfume industry of working on Personal Care products extensively, across multiple categories like; Creams/Lotions/ Ayurvedic products

Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.

Overall mgmt. of QA, QC Responsibilities for Packaging materials used in personal care, color cosmetics, perfume & aerosol products Mgmt of stability study, packaging materials dev. used in personal care, color cosmetics, perfume & aerosol products Required Candidate profile Min. 8 Yrs of exp in handling Packaging / Quality Assurance/Quality Control managerial responsibilities in a Cosmetics/Personal Care Products/ Perfume & aerosol Manufacturing company.

Role & responsibilities : Candidate should have experience in Primary/Secondary packing Key Skills: Bottle Packing CVC/Dry Syrup Packing Must have skills on Primary/Secondary are equipment operation and cleaning operation Trouble Shooting in CVC Bottle packing (Secondary) Key Skills: Blister Packing BQS & Elmach CAM & IC150 Cartonator (Automatic Machine) Track & Trace Work Location : UNIT V Jadcherla (80 km far from the Hyderabad) Interested one share there resume to : sharadha.b@hetero.com Contact Number: 9100408534/8121003471

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Walk In Drive For Quality Control Department In Formulation Division @ Jadcherla Department:- Quality Control Qualification :-BSC | B Pharmacy | MSC | M Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Quality Control Formulation ( HPLC,GC,UV,Dissalution, LCMS, GCMS). About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Job Description: NDDS (Novel Drug Delivery System) Scientist - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop NDDS formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 4 to 7 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-4 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee technical aspects of projects, ensuring timely completion and quality delivery. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs. Conduct thorough analysis of technical issues and provide effective resolutions. Ensure compliance with industry standards and regulatory requirements. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Excellent problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills. Experience with technical tools and technologies is desirable. Ability to lead and motivate high-performing teams to achieve exceptional results.

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Job Title: Manager Job Grade: M2 Function: Corporate Quality Compliance Sub-function: Complaints Manager s Job Title: Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 10% Job Requirements Educational Qualification M. Sc (Life Sciences) / B. Pharm Specific Certification Nil Skills Good Technical Communication Skills, Investigation writing, reviewing, and editing experience, candidate should have worked in USFDA work environment. Experience 13-14 years

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. COntact Person --Divya /Joy /Jenifer **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

Create and manage Quality Control (QC) master data in the Laboratory Information Management System (LIMS), including product specifications, test methods, and sampling plans. Ensure the accuracy, completeness, and compliance of master data with regulatory requirements and internal SOPs. Perform self-review and coordinate for Level 2 review and approval. Collaborate with QC, QA, IT, and other relevant departments to gather required documents and inputs for master creation and updates. Manage master data changes in line with approved change controls, ensuring timely and compliant updates. Troubleshoot and resolve data-related issues in LIMS, coordinating with IT or vendors when required. Maintain up-to-date documentation of master data changes and support audits by providing necessary LIMS records. Ensure all activities adhere to GMP, regulatory guidelines (like USFDA, MHRA, WHO), and internal quality standards.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

"Hiring Event Announcement" MFG Production Operators (ITI): 3 to 8 Experience in Injectable production, filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing Operators ( ITI): 3 to 8 Experience in Injectable packing activity. Date & Time : 31st May 2025 || 09 AM to 3 PM IST Venue : Ahmedabad (Invites will be shared based on your shortlisting) Registration Link copy : https://talentcommunity.baxter.com/flows/manufacturing-packing-operators-31st-may-25-gqengvlfs EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive LLM (NPD) Job Requisitions No : 9102 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 380054 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025