223 Fda Jobs - Page 3

(We are looking fo the Immediate joining candidates or willing to leave early for their current company) Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile 2-7 years of experience Prior experience of working in Regulated plants (USFDA/MHRA Approved) Perks and benefits Working in a state-of-the-art fully automated world class manufacturing. Opportunity to work on diverse dosage forms in a multi-product facility. Attractive attendance bonus & Special Allowances Unmatched opportunities to learn and grow Thanks & Regards Dhivakar D BVR People Consulting dhivakar@bvrpc.com

As a Regulatory Affairs Coordinator at Cipla, your primary responsibility is to ensure timely approvals from the FDA (Loan License units) by effectively coordinating with internal stakeholders and FDA teams for the submission of various applications. Your role also involves developing strong relationships with external stakeholders and advocating for licensing approvals for Cipla LL products. Your key accountabilities include: - Securing timely regulatory approvals from State FDA and CDSCO offices for loan license units, which includes obtaining approvals for various applications such as fresh loan licenses, additional product permissions, test licenses, India Business Tender Certificates, WHO-GMP, COPP, etc. - Coordinating with internal stakeholders to ensure timely applications and resolution of queries for approvals. - Maintaining a master tracker list of all permissions/approvals for the FDA (LL) team. - Building and maintaining relationships with external stakeholders in FDA and CDSCO offices. - Monitoring the timely release of CMCL for local and export markets, ensuring compliance with regulatory requirements and pharmacopeial changes. - Addressing major challenges such as obtaining India Business Tender Certificates, test licenses, and timely FDA permissions and label artwork approvals to support the Tech transfer team. In this role, you will interact with various departments including QA, R&D, FDA coordination team, and Regulatory Affairs. Additionally, you will engage with Deputy Drug Controller CDSCO, Assistant Drug Controller, Assistant Drug Inspectors, and Drugs Inspectors. Your key decisions will involve various FDA/CDSCO applications and submissions at state FDA/CDSCO offices, as well as strategizing for key license approvals in consultation with your Reporting Manager. To excel in this role, you should possess a B.Sc./B.Pharm degree, have good coordination and communication skills, regulatory experience, and 5-10 years of experience in the pharmaceutical industry. Join us at Cipla and contribute to ensuring smooth regulatory approvals for our loan license units and fostering positive relationships with external stakeholders.,

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 excited to invite applications for the position of Senior Validation Engineer. In this role, you will be pivotal in ensuring the compliance and quality of our innovative software solutions tailored for the life sciences sector. As a Senior Validation Engineer, you will collaborate with diverse teams to develop comprehensive validation strategies, create and execute test cases, and maintain the project quality standard. Responsibilities - Hands on work at an individual capacity leading to deliverables - Diligently work with Product, Engineering and Testing teams to gain understanding of Product functions. - Review Product Requirements including Epics, User stories, User Requirements, Software Requirements etc. - Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines - Create realistic test cases and test data based on customer usage scenarios. - Execute test cases, create defects, create deviations, and report test results. - Peer review Test cases, test data and Test designs - Work in a highly collaborative team environment, with communication across many team members. - Good understanding of the company QMS standards - Author documents in accordance with the QMS guidelines - Lead of team of people Provide ongoing guidance, allocate work, review work - Manage the Validation of a product - be responsible for the delivery quality and timelines Requirements - BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical or related field. - Must-have 5+ years of Computer System Validation and Product Software Validation testing experience in a regulated environment. - Good knowledge of Product development life cycle - Understanding of GMP, FDA and ISO regulations - Good knowledge of testing tools and Microsoft office products - Self-motivated, willing to learn new concepts, technologies, and products quickly. - Excellent interpersonal, writing and communication skills, and troubleshooting skills. - Passionate about testing, Validation, and product quality - Able to train and help colleagues with less experience; be able to lead small projects. 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 foster creativity, a sense of community, and are critical to our future success as a company.,

You will be working in the Operations department of Pharma Solution business located in Lexington. Your role as a Manufacturing Operator will involve performing various production activities such as component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. Your key responsibilities will include complying with all relevant policies and procedures, performing line clearances and cleaning/sanitization, operating and maintaining production equipment, ensuring proper ingredients and quantities of batches, executing validation protocols, maintaining records, and following Good Manufacturing Practices. You will also review SOPs, provide feedback on process improvements, troubleshoot process issues, and participate in process improvement activities. To qualify for this position, you should have a High School education or equivalent, along with at least 2 years of experience in an industrial or manufacturing environment. Experience in pharmaceutical manufacturing and/or aseptic manufacturing is preferred. You should have mechanical aptitude, the ability to follow regulatory requirements, read and interpret instructions, work effectively in a team, and demonstrate consistent attendance and reliability. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) that provides end-to-end development and manufacturing solutions across the drug life cycle. The company offers a wide range of services globally, including drug discovery, process development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS also specializes in developing and manufacturing highly potent APIs, sterile fill/finish, biologics, and other pharmaceutical products. As a Manufacturing Operator at Piramal Pharma Solutions, you will play a crucial role in ensuring the quality and efficiency of production processes while adhering to regulatory standards and contributing to the growth and success of the organization.,

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement validation strategies and master plans (VMP) in compliance with FDA, EU GMP, WHO guidelines. Oversee validation document preparation ( URS, IPD, PFDs, P&IDs, and FRS ) and ensure timely customer approvals. Supervise and mentor the validation team, ensuring training, performance tracking, and continuous improvement. Maintain compliance with Good Documentation Practices ( GDP ); manage SOP updates and audit readiness. Lead risk assessments ( FMEA ), impact analysis, and closure of deviations/ CAPAs under change control processes. Collaborate with QA, Engineering, R&D, and Project teams to ensure project and validation alignment. Monitor validation progress, analyze results, and present regular status reports to senior management. Represent validation activities during audits and regulatory inspections. Required Skills: Strong understanding of pharmaceutical validation, automation processes , and regulatory frameworks Proven leadership and team management abilities Excellent communication, presentation, and stakeholder engagement skills Strategic thinking with a focus on compliance and on-time delivery Proficiency in MS Office and technical documentation systems

Medical R&D Team Lead-Chennai-10+years-NPD Job Category: TEAM LEAD Job Type: Full Time Job Location: chennai Years of Experience: 10+ years Position Overview This is an excellent opportunity to work for the global leading company in the field of gas control equipment. The focus of this role is managing our R&D team based in Chennai who are focused on Healthcare products and covering mechanical, electrical, electronics and software disciplines. Duties & Responsibilities Managing the teams actions to delivery New Product development projects. This is an end to end responsibility of successful project delivery from gate 0 to post project audit. Manage the R&D budget, timelines, and resources effectively to achieve project goals on time and within scope Collaborate with business managers, product managers, regulatory, production, purchasing to ensure that new products and technologies meet healthcare standards, regulatory requirements, and market needs. Contribute to align the R&D strategy with the business growth goals Creative input to the NPI projects and program Point of contact for technical questions from customers/production/product management/quality & regulatory Creation, completion, and management of technical files for relevant product lines Determining test criteria, organising testing and interpretation of results Working closely with procurement to drive cost savings Working closely with production to deliver optimized production processes Metrics of success for the role Delivery of the product roadmap Project performance KPIs including, time to market, development cost, product cost, sales impact and product performance criteria Delivery of cost reduction projects Delivery on quality improvement projects Required Qualifications: Masters in Engineering Mechanical or Electronics as a minimum Minimum of 10 years of experience in R&D leadership in the healthcare or medical device industry or highly regulated industry. 3-5 years experience working in a multinational, preferably American led organization working in a Global function preferably R&D. Experience leading Engineering process (Stagegate) and systems (PLM). Preference to those with a strong understanding of healthcare regulations (FDA, CE), quality standards (ISO), and product standards (NFPA, HTM, ISO, CFR, CGA, CRN

• Facilitate the implementation and support of SAP Public Cloud- 2 SL System and 3 SL System • Experience in Cloud Transport Management process related to FICO part • Good Knowledge in Business Process Tiles • Have good exposure of the Data Migration Cockpit • Good exposure on Banking • Bank Master Data • House Banks and Account Ids • EBS • DME • Facilitate the implementation and support of SAP Financials with expertise and focus on FICO Controlling Cost Center Accounting, Profit Center Accounting, Product Costing, Month End process and Treasury. • Expertise in Process, Configuration & Customization of SAP FICO sub-modules: FI-New GL, FI-AP, FI-AR, Asset Accounting. • Perform detailed analysis of complex business process requirements and provide appropriate system solutions; identify, interpret, validate, and document customer requirements. • Facilitate workshops to collect business requirements. Map client business requirements, processes, objectives, develops necessary product modifications to satisfy clients' needs.

S4HANA Finance for Group Reporting Job Description Should have experience 8-10 years end to end implementation experience of SAP S/4 HANA for Group reporting. Interactions with various client functional teams to understand the requirements and to finalize the design of each model in SAP Group reporting CA/ICWA candidates are preferred but otherwise should be a Postgraduate as minimum educational qualification like MBA / M. Com etc. SAP FICO (S/4HANA 1809 & above) experience is preferable. Good hands-on experience in AO (Analysis for Office) reports experience Balance sheet, Profit & Loss, Cash flow reports and Custom analytic queries. Should have sound knowledge/configuration experience on the below areas: Should be able to design and configure business scenarios In S4hana Group Reporting Knowledge in Activate GR -1SG best practice content. Monitoring Month-end activities, Master data management, Data loadings. Good knowledge in create Break Down Categories, Sections and Sub-item mapping Currency translation Data Validations & Reclassifications Intercompany Matching & Reconciliations Intercompany Eliminations & Consolidation of investment (Rule based COI and ABC COI). Good experience in Analysis Office (AO) reports, Reporting rules & hierarchies Good experience in creating Ad-hoc reports in Fiori Apps Ability to create Project documents like Fit Gap analysis, Test Scripts, Training Documents and Configuration documents etc. Ability to provide Training to end Users Good exposure to assist the business users during UAT Knowledge on Different Accounting Standards and its usage Must be a very good team player with good interpersonal and communication skills Business Travel: Project specific travelling is mandatory for all the SAP Consultants

Key Responsibilities: Greenfield S/4HANA Implementation •Lead and manage greenfield S/4HANA implementation projects within the life sciences/pharma industry. •Design and configure the SAP CO module to meet specific business requirements and regulatory standards. •Oversee system integration, testing, validation, and data migration activities. Client Interaction and Workshops : •Conduct client meetings to gather requirements, present solutions, and provide project updates. •Facilitate workshops to engage clients, understand their operational challenges, and deliver tailored solutions. •Build and maintain strong client relationships, serving as the primary point of contact throughout the project lifecycle. Consulting and Advisory: •Provide expert advice on SAP CO best practices, S/4HANA capabilities, and industry-specific standards, with a focus on life sciences/pharma. •Develop and propose innovative solutions to meet client needs, ensuring adherence to industry regulations such as GMP (Good Manufacturing Practices). •Conduct system assessments and audits, providing recommendations for process improvements and compliance. Project Management: •Develop and manage project plans, including timelines, budgets, and resource allocation. •Coordinate with cross-functional teams, including technical consultants, business analysts, and project managers, to ensure successful project delivery. •Monitor project milestones, ensuring timely completion of deliverables with a focus on industry-specific requirements. Training and Documentation •Develop and deliver training sessions for end-users and key stakeholders. •Create and maintain comprehensive documentation, including business process flows, configuration guides, and user manuals. Travel: •Willingness to travel to client sites as required, including international travel if necessary. •Flexibility to accommodate travel schedules and client needs. Qualifications: Bachelor's degree in Engineering, Life Sciences, Information Technology, or a related field. Minimum of 10 years of experience as an SAP CO Consultant, with a focus on greenfield S/4HANA implementations in the life sciences/pharma industry. In-depth knowledge of SAP CO module, including cost center accounting, internal orders, product costing, and profitability analysis. Strong understanding of the unique business processes, regulatory requirements, and quality standards within the life sciences/pharma industry. Excellent communication, presentation, and client management skills. Proven experience in leading client workshops and delivering complex projects on time and within budget. AP S/4HANA certification is a plus. Preferred skills • Experience with SAP FI (Financial Accounting) and SAP MM (Material Management) in the context of life sciences/pharma. • Familiarity with FDA regulations, GMP, and other industry-specifics

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As part of our EY- Technology Risk team, you'll contribute technically to IT Risk and Assurance client engagements and internal projects. An important part of your role will be to actively establish, maintain, and strengthen internal and external relationships. You'll also identify potential business opportunities for Ernst & Young within existing engagements and escalate these as appropriate. Similarly, you'll anticipate and identify risks within engagements and share any issues with members of the team. We're looking for a Manager to join the leadership group of our EY- Technology Risk Team. This is a fantastic opportunity to be part of a leading firm while being instrumental in the growth of a new service offering. Your key responsibilities are to: - Evaluate a portfolio of controls for design effectiveness, operating effectiveness, and/or risk management outcomes, raising issues as appropriate. - Ensure that assigned control assessments are accurate, effective, abide by policy, procedures, and templates, and meet quality control requirements and are delivered on time, in accordance with the assessment plan. - Test and supervise the delivery of assigned controls not limited to ITGC and ITAC but System Architecture, Operating Systems, Databases, Networks, Security Systems, Cloud Services, Asset Inventories, Incident Management, Recovery Management, ISO27001 & NIST assessment, Privacy Assessment, Cyber Maturity Assessment, IT Policies and Standards Assessment, and Software Development Lifecycle (SDLC); using experience and knowledge to intervene and redirect testing as required, resolving, or redirecting escalations as required. - Manage control owners and other stakeholders, ensuring the success of each assigned review, minimizing contention where possible and requesting support where deemed necessary. - Apply judgment and risk management concepts to identify, formulate findings, and provide valuable insights to the clients to improve processes and manage risks to achieving operational and strategic goals. - Review IT Policies and Standards and ensure that they are as per the different industry standard. - Work closely with cross-functional teams and develop strong relationships as project lead within IT security and GRC projects. - Stay current with and promote awareness of applicable regulatory standards, upstream risks, and industry best practices across the enterprise. - Control frameworks such as COSO, internal control principles, and related regulations including SOX and J-SOX. - Familiar with IT industry frameworks such as ISO27001, NIST, PCI-DSS, SOX, FDA, HIPAA: Privacy, HIPAA: Security, and HITECH Act. - Third-party reporting standards (particularly SSAE16), other reporting and industry-specific standards, and, if applicable, trust-based standards such as SysTrust and WebTrust. Skills and attributes for success: - Provide guidance and share knowledge with team members and participate in performing procedures especially focusing on complex, judgmental, and/or specialized issues. Work with the team and the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. - Experience in conducting information security assessments including business continuity plan audits, network security audits, and infrastructure audits. - Perform NIST assessments, ISO assessments, and privacy impact audits, Data Privacy and GDPR implementation, experience in developing Data inventory and Third-Party Risk Assessment. - Maintain relationships with client management to manage expectations of service, including work products, timing, and deliverables. Demonstrate a thorough understanding of complex information systems and apply it to client situations. - Bring and utilize extensive knowledge of the client's business/industry to identify technological developments and evaluate impacts on the client's business. Demonstrate excellent project management skills, inspire teamwork and responsibility with engagement team members, and use current technology/tools to enhance the effectiveness of deliverables and services. - Understand EY and its service lines and actively assess what the firm can deliver to serve clients. To qualify for the role, you must have a Graduate (CS/IT, Electronics, Electronics & Telecommunications)/MBA/M.Sc. with at least 6 years of experience. Bring your significant experience in applying relevant technical knowledge in at least one of the following engagements: (a) ISO assessments, (b) NIST assessments, (c) Data privacy audits, (d) Network and Infrastructure audits, (e) Cyber Maturity Assessment, (f) IT Policies and Standards Assessment, (g) IAM and IT Asset Management, (h) IT Health Check. Ideally, you'll also have a robust understanding of program and project management practices and familiarity with a typical IT systems development life cycle. What we look for: A team of people with commercial acumen, technical experience, and enthusiasm to learn new things in this fast-moving environment. Opportunities to work with EY technology risk practices globally with leading businesses across a range of industries. What working at EY offers: At EY, we're dedicated to helping our clients, from startups to Fortune 500 companies, and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees, and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer support, coaching, and feedback from some of the most engaging colleagues around, opportunities to develop new skills and progress your career, and the freedom and flexibility to handle your role in a way that's right for you. EY | Building a better working world: EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

The role of Calibration Technician/Engineer involves carrying out calibration activities at various sites across India and abroad. Your main duties will include executing calibration tasks for a range of equipment including computerized systems, plant equipment, laboratory equipment, facilities, utilities, and process control systems. These calibrations will be conducted to support GMP/FDA requirements for our clients. The ideal candidate for this position should have prior experience in providing calibration services. The job is based in Vasai, with travel required to different locations for on-site calibration work. As a Calibration Technician/Engineer, you will play a crucial role in ensuring that all equipment and systems meet the necessary calibration standards. Your attention to detail and ability to work in compliance with regulations will contribute to the success of our calibration department.,

We are seeking a detail-oriented and experienced Manager, Quality Assurance to lead our QA team and ensure the highest standards of quality across products, processes, and services. The QA Manager will be responsible for developing and implementing quality assurance policies, conducting audits, analyzing data, and collaborating with cross-functional teams to drive continuous improvement. Key Responsibilities: Lead and manage the Quality Assurance team, including hiring, training, and performance management. Develop, implement, and maintain QA standards and procedures in accordance with regulatory requirements and best practices. Monitor and report on quality metrics, identifying areas for improvement. Conduct regular internal audits and coordinate external audits and inspections. Oversee root cause analysis and corrective/preventive action (CAPA) processes. Collaborate with R&D, Production, Engineering, and other departments to integrate quality into product and process design. Ensure compliance with industry standards (e.g., ISO, FDA, IATF, CMMI \u2013 depending on industry). Manage documentation and change control for QA processes and records. Review and approve quality-related documentation (test plans, validation reports, specifications, etc.). Champion a culture of quality across the organization. Qualifications: 10+ years of experience in Quality Assurance, with at least 3 years in a managerial or supervisory role. Strong knowledge of QA methodologies, tools, and regulatory standards. Experience with quality systems such as ISO 9001, Six Sigma, Lean, etc. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills. Proficient in quality management systems and tools. Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law. People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded:click here to access or download the form. Complete the form and then email it as an attachment toFTADAAA@conduent.com.You may alsoclick here to access Conduent's ADAAA Accommodation Policy. At Conduent we value the health and safety of our associates, their families and our community. For US applicants while we DO NOT require vaccination for most of our jobs, we DO require that you provide us with your vaccination status, where legally permissible. Providing this information is a requirement of your employment at Conduent.

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

Regulatory Affairs Executive ( for Cosmetic Industry ) Kheda, Gujarat 3–5 Years Experience CTC up to 6 LPA Strong knowledge of global cosmetic regulations (EU/USA/ASEAN/Gulf) Expertise in labeling, claims review, and documentation

Role & responsibilities Analyze U.S. generic market opportunities using IQVIA, FDA databases, Orange Book, and competitive intelligence tools Identify and prioritize products based on market size, competitive landscape, development feasibility, and potential profitability Conduct patent, exclusivity, and litigation analysis (Paragraph IV, FTF opportunities) Work closely with R&D, Regulatory, Legal, and Supply Chain to ensure selected products align with internal capabilities Track product development pipeline and communicate risks or bottlenecks Prepare business cases and forecasting models for executive decision-making Preferred candidate profile: Bachelor's or Masters in Pharmacy, Life Sciences, or related field MBA or PGDM (preferred) 25 years of experience in portfolio management, regulatory affairs, or business analytics in the pharmaceutical industry Strong understanding of U.S. FDA regulatory and legal environment for generics

Role & responsibilities: Experience with REST Assured API, SOAP UI automation testing. Develop, maintain, and execute automated test scripts with web applications. Collaborate with development, QA, and DevOps teams to ensure the highest quality of software releases. Work closely with cross-functional teams to understand business requirements and translate them into test scenarios. Define, Identify and implement best practices for test automation processes and tools. Analyze and interpret test results, report defects, and ensure issues are resolved. Generate detailed test reports and metrics to track testing progress and effectiveness. Mentor and train junior team members on test automation practices and framework usage. Participate in code reviews and provide feedback to improve code quality. Preferred candidate profile: Bachelors degree in related field (Computer Science, Computer Networking, IT Systems) Strong knowledge of QA methodologies and tools with demonstrated experience in Automation role. Proven track of building test automation and drive efforts for implementing test frameworks on web/mobile or service-oriented architectures. Integrate the test automation framework with CI/CD pipelines to enable continuous testing. Create scalable and maintainable test automation architectures. Hands-on Automation scripting, white box testing experience in Java/ Python or similar languages & TestNG/Junit. 5+ years of QA testing, creating test artifacts and reporting defects. 5+ years of strong automation testing experience preferably Selenium and in Cucumber, BDD, TDD, TestNG. Experience with REST Assured API, SOAP UI automation testing.

We at SUN PHARMA are hiring for 'Manager- New Product Launch ' role. Sun Pharma is the No. 1 and largest pharmaceutical company in India with over 8% market share in the domestic market (AIOCD AWACS for 12 months ending Sept 2023). The company has been ranked No. 1 with over 12 different classes of doctors (SMSRC Prescription Data). Sun Pharmas branded generics business in India commands leading position in high-growth chronic therapies and strong positioning in the acute segment. Job Summary: The position will be responsible for the planning, monitoring, execution and risk management for launch of new pharmaceutical products. This role involves coordinating with cross-functional teams ensuring product launches from in-house and CMO in compliance with regulatory and quality requirements. Ensure launch within agreed timelines and budgets to achieve launch objectives. Scope of work include First Timeline Launches, market extension, 2nd wave launches, relaunches of in-house and in-license products across dosage forms for US, EU and emerging markets Key Responsibilities: Project Management: Lead the end-to-end project for new product introductions including planning, execution and risk management using IMPULSE process. Identify bottlenecks including resources constraints, technical issues & provide inputs for escalation to the senior team for de-bottlenecking. Conduct structured Weekly Cross Functional Meetings with stake holders (each plant) to understand constraints, project issue and drive launch activities Cross-Functional Collaboration: Collaborate with manufacturing, R&D, regulatory affairs, procurement, marketing, supply chain, and quality assurance teams to ensure successful product manufacturing, supply and launch. Act as strong interphase between Markets & Manufacturing - Communicate market change dynamics to plant & NPLR impact. Work closely with MSTG-Production to schedule scale up & characterization batches & launch batch execution. Engage with PDD and marketing for commercial Pack style finalization Co-ordination with procurement for material supplies and logistics team for launch projects Market Analysis: Co-ordination with marketing & BD to get updated BC and evaluate project feasibility basis COGS and marketing business case. Conduct Monthly Project Update Meetings with marketing team, providing visibility on product readiness & capturing marketing inputs for improving service level Regulatory Compliance: - Update launch calendar, based on regulatory approval timelines & IP updates. Ensure all products launches meet regulatory requirements for the market of interest, including local FDA guidelines and international regulations. Budget and Risk Management: Develop and manage project budgets, ensuring that projects are delivered on time and within budget constraints. Identify potential risks associated with product launch and develop mitigation strategies. Stakeholder Communication: Prepare project charter and present project updates to senior management and stakeholders. Facilitate communication between teams to ensure alignment on objectives and timelines. Continuous Improvement: Implement best practices and process improvements to enhance the efficiency of the NPI process Reports Update and maintain management dash boards, launch calendar, project trackers, ES&OP and Monthly Presentation Qualifications: Education: Bachelors degree in Pharmacy, Life Sciences, Business, or a related field. A Masters degree or MBA is preferred. Experience: 5+ years of experience in New Product Launch, Supply Chain Planning and project management within the pharmaceutical industry, specifically in generics. Prior experience of launch of Topical , Injectables dosage form is desirable Knowledge: Strong understanding of regulatory requirements for pharmaceuticals and experience with product lifecycle management. Skills: Excellent in Supply planning, project management, SAP and analytical skills. Proficient in using SAP, Microsoft office and Project Management Tools. Communication: Strong verbal and written communication skills. Ability to effectively present information to various stakeholders. Leadership: Proven ability to lead cross-functional teams and drive results in a fast-paced environment.

Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with the lens of ensuring they are in line with applicable laws and critical industry practices. Providing legal guidance to, and working closely with Compliance, Business and other stakeholders, in this regard. Drafting, reviewing, negotiating, and closing contracts (relating to the payments/ financial services business, banking contracts etc.) with the internal and external stakeholders, with a view to protect the organization against any legal exposure and to minimize liability. Provision of legal advice in framing/ review of policies, and other internal and external documents. Staying updated on the regulatory environment; identify, interpret, and analyse existing and new legislations/ amendments/ notifications that may impact business; and basis its applicability and implications, bring it to the notice of appropriate internal functions as required. Advise and assist all stakeholders including Compliance and Business on both, ongoing legal risks and anticipated/ new legal risks arising by virtue of new laws or regulations. Internal process Adhere to timelines in reviewing and vetting all documentations, including agreements. Follow up with internal stakeholders, including business leads,for time bound closure of agreements;provide advice in course corrections; escalate when required. Monitor the timelines for submission of applications pertaining to licences (new and renewals) to regulatory authorities and ensure timely escalation where required. Learning Maintain a database on applicable laws comprising FAQs, dos anddontsas a ready reference. Keep a track on the latest lawsand notifications (including all notifications issued by the RBI), and proactively advise the management and business about such laws/ amendments and its implication on business, and accordingly suggest changes in process/ procedure. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe on our blog. Life at PhonePe PhonePe in the news

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services 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 : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation protocols, and reports. Product Quality Oversight: Perform in-process checks during manufacturing and packaging to ensure adherence to specifications. Review and approve batch records and certificates of analysis (COA) before product release. Investigate non-conformances and implement corrective and preventive actions (CAPA). Validation & Qualification: Support validation activities for equipment, processes, and cleaning procedures. Participate in qualification of facilities, utilities, and equipment. Training & Team Collaboration: Train staff on quality-related topics, including GMP and compliance requirements. Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality objectives are met. Regulatory Compliance: Stay updated on current pharmaceutical regulations and quality guidelines. Ensure adherence to regulatory requirements for product registrations and submissions. Qualifications: Bachelors or Master’s degree in Pharmacy or a related field. Certification in GMP, ISO 9001, or other relevant quality standards is an advantage. 2 to 4 years of experience in quality assurance in the pharmaceutical industry. Key Skills: Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, EMEA). Excellent documentation and analytical skills. Proficiency in quality tools and techniques, including root cause analysis and CAPA. Attention to detail and problem-solving abilities. Effective communication and interpersonal skills.

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Adaptable and flexibleCommitment to qualityHands-on experience with trouble-shootingAgility for quick learningAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy