2347 Life Sciences Jobs - Page 25

Major duties and responsibilities: Submission Reviewer is a centralized role that: Has oversight of the reporting rules configuration for compounds, marketed drugs, devices, and vaccines to ensure proper distribution / submission to health authorities, affiliate countries, license partners / collaboration partners. Has regulatory reporting expertise in all major regions. Performs regulatory reporting in all major regions in accordance with policies, SOPs and HA regulations. Has oversight of ICSR submission related activities in all regions, ensuring safety database is operational, prompt escalation of system outage affecting ICSR distribution / submission process. Distribution of Dear investigator letter to investigators. Monitor Distribution mailbox and take appropriate action as per the received emails. Is the SME during internal / partner audits and inspections. Provide or receive training on Customer-specific processes, systems, or products. Other tasks as required.

The Researcher of Preclinical (Toxicology and Biocompatibility) in this role will apply expertise in toxicology and medical device biocompatibility testing including development of toxicity study design and biocompatibility testing design for drug/drug packaging system/medical device development, monitoring the studies, and development of toxicological risk assessments. The successful candidate will have hands-on experience in hazard evaluation of chemicals used in manufacturing and will participate preparing reports for external regulatory bodies in accordance with ICH and ISO10993-17. This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices for Peritoneal dialysis, Hemodialysis, and Acute therapies. Essential Duties and Responsibilities: Assist or work independently in designing, planning, monitor various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervisions from direct manager and senior members of the organization. Assist or work independently as an author for toxicological risk assessment reports on leachables, extractables, residual solvents and excipients and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17. Work independently on hazard evaluation of chemicals used in manufacturing and issuing safety data sheet (SDS). Participate as preclinical/toxicology representative and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects with effective collaboration and deliverables. Participate in change control management and impact assessment. Propose options, work closely with stakeholders and develop action plans for problem-solving, product and process improvement. Prepare and/or review nonclinical eCTD and PBRER sections. Utilize in silico tools to assess toxicological endpoints. Qualifications The position requires relevant technical knowledge in toxicology and biocompatibility testing. Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, ISO 10993. Excellent oral and written communication in English language. Utilize a logical, methodical approach when problem solving, developing solutions and making recommendations. Ability to work independently and prioritize assignments to meet project schedules. Ability to design experiments, monitor toxicology studies, interpret the results and draw meaningful conclusions from the data and prepare reports for external regulatory bodies Education and/or Experience: Master of Life Sciences / Veterinary / Biotechnology / Pharmacy (or relevant) with 4-6 years of relevant work experience, or PhD with relevant experience during thesis (&/or Post-doc) e.g., in in vitro and in vivo pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals, biocompatibility testing of medical devices, drug packaging system. Skills: Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders, Fluency in English. Can effectively communicate with internal and external customers. Solid computer skills : email, good documentation practice, and collaboration tools: e.g., Zoom, Teams, Microsoft Office products, etc. Demonstrated ability to work in a matrix environment with multiple stakeholders Demonstrates flexibility and the ability to shift gears between projects comfortably. Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables.

Candidate should have Integration experience with good communication skills in order to gather requirements from the client and solutioning the interface requirements. Integrations includes devices in the hospital which includes Lab analyzers, Radiology, Kiosk, Payment gateway, Medical devices, etc. and third-party systems ERP, Mobile app, etc. and government statutory integrations. To develop integration API using NodeJs and MongoDB and support the various types of Integrations using FHIR, HL7 standards and proprietary requirements. 6-8 years of experience as developer with NodeJS, MongoDB and Integration Technical Skills 1.Node.js, 2.MongoDB 3.Javascript 4.Integration engine such Mirth(Nextgen) / Cloverleaf / Rhapsody. Desired Skills 1.Communication Skills 2.Good documentation skills 3.Knowledge of GIT, JIRA 4.Knowledge of Healthcare domain

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

We re Hiring: Officer / Executive/ Sr Executive QA (Validation & CSV) Location: Gummidipoondi Injectable Plant Job Type: Full Time No. of Positions: 10 Education Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / B.Tech (Life Sciences / Pharma / Engineering streams) Experience: 2 to 6 years Preference for candidates with experience in sterile injectable validation and computer system validation (CSV) Key Responsibilities: 1.Prepare, review, and execute validation protocols, reports, and lifecycle documents. 2.Execute DQ, IQ, OQ, PQ for aseptic processing equipment including: Sterilizers (Autoclaves, Dry Heat Sterilizers) Depyrogenation tunnels Filling lines (vial, ampoule, prefilled syringe) Isolators / RABS (Restricted Access Barrier Systems) HVAC systems for cleanrooms LAF (Laminar Air Flow) units VHP (Vaporized Hydrogen Peroxide) systems 3.Familiarity with regulatory guidelines: 21 CFR Part 11, EU GMP Annex 1 4.Ensuring compliance with regulatory and quality standards If you re looking to grow your career in pharmaceutical validation and digital compliance, join our QA team driving quality and regulatory excellence. Apply for this position Allowed Type(s): .pdf, .doc, .docx By using this form you agree with the storage and handling of your data by this website. * About Us Caplin Steriles Limited, a subsidiary of fast growing pharmaceutical company Caplin Point Laboratories Ltd, specifically targeted towards regulated markets for Injectables and Ophthalmics.

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Let s find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow Who we are A healthier future drives us to innovate. Together, more than 100 000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let s build a healthier future, together. Roche is an Equal Opportunity Employer. "

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Are you ready for a new beginning? We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity s biggest challenges. Since we began more than a century ago, this has been our guide. It s how weve gotten so far. And it s how well impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. We re here to better our world with biology. In this role you ll make an impact by: - developing world class prior-art search and analyses within the biotech area - working with Intellectual Property colleagues around the world and delivering impactful landscape and state of the art analyses. Potentially relevant experience: - more than 1 year experience in patent search and analyses. - an MSc, preferably within life sciences, biotechnology, biochemistry, or molecular biology, possibly supplemented with a PhD. -Fluent in written and spoken English and capable of expressing yourself in logical and easy-to-understand reports. - self-disciplined, systematic and comfortable with driving patent activities, working both independently and within a team Could our purpose be yours? Then apply today! At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV. Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status. Want to learn more? Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com Not the right fit for you? Even if this job isnt the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away. Stay alert: Avoid recruitment scams At Novonesis, we are committed to maintaining a safe and transparent recruitment process. Please be aware of potential scams targeting job seekers and take note of the following: Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process. Novonesis does not make employment offers without conducting interviews with candidates. If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. We encourage you to verify the legitimacy of the message by contacting us directly through our official channels.

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager, Global Regulatory Intelligence The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS - monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes producing regulatory intelligence outputs that enable timely and efficient product filings worldwide - for example, compiling summaries of country-specific regulatory requirements , analyzing recent or upcoming changes in regulations, and providing recommendations to teams on filing strategies that maximize speed and compliance. The Senior Manager is accountable for delivering these assigned intelligence outputs to a high standard of quality. Processes & Systems Ownership: Oversee the efficient operation of specific intelligence-gathering systems and processes . The Senior Manager may be responsible for maintaining and improving tools or databases used for monitoring regulations and for ensuring that intelligence monitoring, analysis, and communication processes run smoothly in their area of ownership. They work in partnership with colleagues across GRAAS to refine these systems and may evaluate opportunities for automation or outsourcing to improve efficiency. Regulatory Analysis & Strategy Input: Analyze regulatory trends across Amgen s global footprint, identifying differences and commonalities in submission requirements between regions or product types. Based on this analysis, recommend practical approaches to dossier content and preparation that will satisfy local requirements while enabling globally efficient submissions. The Senior Manager provides this strategic input to global and local regulatory teams to influence filing strategies and ensure alignment with intelligence insights. They also identify major impending regulatory changes and help plan for regulatory change management efforts across the business (providing input to any large regulatory change projects). Cross-Functional Collaboration: Develop trusted relationships with cross-functional colleagues - including Global and Local Regulatory Affairs teams, Regulatory CMC, Policy staff, and others - to integrate intelligence into regulatory strategy and decision-making. The Senior Manager engages GRAAS policy staff, product strategy leads, and other experts to help establish priorities for intelligence activities and to execute on agreed deliverables. They often lead or coordinate cross-product regulatory projects (such as analyses to support multiple product filings) under the direction of the RI Director. In doing so, they ensure that intelligence findings are translated into actionable strategies and that any recommendations for policy advocacy (to promote global harmonization of requirements, for example) are communicated to the relevant teams. Continuous Improvement: Engage in continuous improvement of Regulatory Intelligence processes. The Senior Manager monitors progress against intelligence workplans and objectives, and conducts regular reviews with the RI Director to report on outcomes. They propose and implement enhancements to tools, methodologies, and workflows to increase the effectiveness of intelligence gathering and dissemination. For instance, they might help refine how regulatory information is captured and shared, contribute to templating requirements for future automation projects, or update procedures in response to lessons learned. Knowledge & Skills: Regulatory Expertise: A strong foundation in regulatory affairs is required . The Senior Manager should have recent global filing experience and in-depth knowledge of regulatory agency guidelines and procedures across major and non-major markets. An understanding of local regulatory processes and how they impact global submissions is important. The role demands the ability to synthesize complex regulatory information (from disparate sources and regions) and distill it into clear, actionable insights and recommendations. Project Management & Communication: Excellent project management skills are needed to handle multiple intelligence projects and deliverables. The Senior Manager must be able to track tasks, meet deadlines, and coordinate input from various contributors. Strong presentation and interpersonal communication skills are essential in order to effectively communicate intelligence findings to stakeholders and to represent the intelligence function in cross-functional discussions. The ability to influence without direct authority (especially when recommending changes to regulatory strategy based on intelligence) is a key soft skill for this role. Technical and Process Skills: Preferred candidates will bring experience in systems management and process management , as the role involves working with databases/tools and improving processes for information gathering. Familiarity with knowledge management practices and change management principles is also beneficial - for example, knowing how to systematically capture regulatory knowledge and support teams through major regulatory changes. An innovative mindset toward leveraging technology (including potential use of AI tools for intelligence) is a plus, given Amgen s interest in future automation of submission-ready content. Qualifications: Basic Qualifications: A combination of advanced education and relevant experience in life sciences/regulatory affairs. For instance, a Doctorate degree in a related field with ~4+ years of experience, Master s degree with ~3+ years, Bachelor s degree with ~5+ years, Associate s degree with ~10 years, or even a high school diploma/GED with ~12 years of directly related experience could be considered acceptable minimums. (These ranges align with internal job level guidelines for a role at the Senior Manager level. ) Preferred Experience: Relevant industry experience in biopharmaceutical regulatory affairs (especially in regulatory intelligence, policy, or strategy functions) is highly desirable. The ideal candidate will have a track record of successfully managing regulatory information or contributing to regulatory submissions across multiple regions. Experience working on cross-functional teams and exposure to regulatory policy development or external advocacy would be a plus for this role. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Job Title : Integration Specialist - LIMS Grade G11A Department/Group: Global IT/Projects Location: Baroda Job Summary Integration Specialist - LIMS, will be responsible for the integrating various lab instruments/software with LIMS application for successfully establishing paperless environment in QC/R&D Labs. This role requires a deep understanding of laboratory workflows, Instrument connectivity techniques, strong technical skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Job Description Role and Responsibilities Support in QC/R&D lab instrument integration with LIMS application, at the time of LIMS implementation at various locations of SUN Pharma. Develop and execute test scripts, and relevant documentations required as part of validation activity. Configure LIMS software to meet the specific needs during Instrument integration activity. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Deep understanding of Lab Software functionality such as Empower, LabSolutions, Chromeleon. Strong command on Data extraction / connectivity methodologies techniques for port based instruments such as balances, pH etc. Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents.

Job Title: Senior Manager - IT Job Grade: G9 A Function: IT Sub-function: EM IT Manager s Job Title: GM - EM IT Head Skip Level Manager s Title: Function Head Title: CIO Location: Mumbai Job Summary Desired Skills & Experience 8+ years of experience in IT program and portfolio management. Experience within the pharmaceutical or life sciences industry would be a plus. Demonstrated experience managing complex and large value programs with cross-functional teams. Understanding of compliance requirements in a pharma environment (e. g Data Policies, etc. ). Experience with digital transformation, ERP, CRM deployments, other complex projects. Familiarity with Agile methodologies and hybrid project management approaches. Excellent interpersonal, communication, and stakeholder management skills. Proficiency with project portfolio tools (e. g. , Zoho, MS Project Online, Asana, etc. ). Ability to multitask and manage multiple deliverables and projects at the same time. Ability to understand business processes from a customer perspective. Ability to work in a team environment, effectively interacting with others. Must be result oriented, and demonstrate adaptability, flexibility and resourcefulness. Areas Of Responsibility Roles & Responsibilities Manage the overall IT project and program portfolio across business units including Commercial, Finance, Supply Chain, HR, R&D, Manufacturing, Quality and Corporate. Define and maintain portfolio governance frameworks aligned with business goals. Lead large-scale IT programs ensuring timelines, budgets, and compliance requirements are met. Drive cross-functional coordination between IT, business stakeholders, vendors, and regulatory bodies. Champion change management and stakeholder engagement. Track and mitigate risks, manage budgets, and support business case development. Identify, interpret and document customer requirements. Facilitate workshops to collect business requirements. Facilitate mapping client business requirements, processes and objectives. Identify gaps, issues and work around solutions. Provide consulting services on both new implementations and existing support projects. Act as a liaison between the business functions and the technical team. Work self-directed and independently; act as subject matter expert/mentor to more junior members. Travel Estimate Travel as per project requirement Job Scope Internal Interactions (within the organization) Cross-functional business heads in Commercial, R&D, Supply chain, Finance, HR, Procurement, Manufacturing, Regulatory and Quality. Coordination with global IT leadership, security, compliance, enterprise applications and infrastructure teams. External Interactions (outside the organization) Engagement with external vendors, implementation partners, and regulatory consultants (e. g. , SAP, Deloitte, PwC, IBM) . Geographical Scope All Emerging Markets Financial Accountability (cost/revenue with exclusive authority) NA Job Requirements Educational Qualification BE/ BTECH/BCOM/MBA Specific Certification PMP Certification would be an advantage Skills IT Program and Portfolio Management, Stakeholder Communication, Agile & Project Management, Vendor Management, Change Management Experience Min. 8 years of experience in business/customer facing roles

Job Title: sLIMS Implementation Support Job Category: Permanent Department/Group: Global IT/Projects Job Code/ Req#: NA Location: Baroda Travel Required: Yes Level/Salary Range: G10 and below Position Type: FTE Contact: NA Date Posted: June-25 Will Train Applicant(s): NA Posting Expires: NA External Posting URL: NA Internal Posting URL: NA Job Summary sLIMS Implementation Specialist will be responsible for the successful deployment, configuration, and ongoing support of our Laboratory Information Management System (SLIMS). This role requires a deep understanding of laboratory workflows, strong technical skills, and the ability to work closely with cross-functional teams to ensure the SLIMS meets the needs of the organization Job Description Role and Responsibilities Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. Provide training and support to end-users, ensuring they are proficient in using the sLIMS. Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the sLIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of sLIMS application as per GMP. Shall be able to create and manage documentation of sLIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in sLIMS implementation, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Proficiency in sLIMS software (Expertise on CaliberLIMS is preferred) Ability to manage multiple tasks simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with SLIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents. Reviewed By: Date: Approved By: Date: Last Updated By: Date/Time:

Job Title : Testing and Documentation Support Grade G11A Department/Group: Global IT/Projects Location: Baroda Job Summary LIMS Testing & Documentation Specialist will be responsible for the thorough testing of LIMS application before deployment or patch deployment. This role requires a deep understanding of laboratory workflows, strong technical & testing skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Job Description Role and Responsibilities Support testing of LIMS functionalities to ensure the functionality available, is working as per users expectation as well as it meets the approved user requirement specification. Develop testing strategy and execute it to meet the implementation timelines. Perform the impact assessment of newly added functions on the existing functionalities. Rigorously test the newly introduced functionalities based on its impact on the existing functionalities. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in LIMS implementation, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Excellent testing skills, with the ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents.

Veeva Systems - Senior Consultant - LIMS Implementation This website uses cookies to improve your web experience. By using the site, you agree to the use of cookies. Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. The Role Join Veeva as we modernize software for the life sciences industry. We are bringing to market a modern cloud solution designed to optimize laboratories with increased efficiency and productivity by streamlining processes. Join the team that will partner with our customers to implement one of Veeva s newest products - Passionate about bringing disruptive technology to customers and have novel ideas for successful GMP software implementation This role will allow you to help our clients to drive new product adoption through successful implementations. This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements. Qualified candidates must be legally authorized to be employed in India. Veeva does not provide sponsorship for employment visas for this position. What You ll Do Lead life sciences customers in the implementation of Vault Quality Suite applications to ensure customer success Guide customers on how to enhance their platforms with an innovative approach through cloud-based software applications Define strategies and implementation programs for deploying Veeva Vault LIMS across organizations Project management including resource planning, leading and motivating a cross-functional team, and project budget tracking and forecasting Primary customer liaison managing communication between the project team, customer, external partners and internal stakeholders Mentor project team and junior consultants in the Professional Services organization Represent Professional Services across multiple engagements and workstreams (e. g. , solution design and configuration, data migration, systems integration, etc. ) Requirements 8+ years of experience implementing and/or supporting LIMS systems Proven track of delivering subject matter expertise on implementation methodology and driving best practices Demonstrated expertise in customer leadership and fostering a collaborative team environment Demonstrated work history in stakeholder management, critical thinking skills, ability to conduct complex and technical communications in a wide variety of settings and audiences, and the determination to see client success with solution implementation Ability to travel upon business requirements Nice to Have Understanding of business requirements, scientific data, compliance considerations, and processes for laboratory information management, life sciences compliance, and/or computer systems validation Experience implementing Laboratory Information Management Systems for life sciences as a consultant, business, or IT representative Direct experience with systems such as LabWare, SQL LIMS, LabVantage, StarLIMS, SampleManager, SmartLab, BIOVIA, Nugenesis, Empower, Laboratory Information Manager System, QMS, ELN, LIMS, and other informatics or similar systems Consulting experience SaaS/Cloud experience Additional annual leave over Christmas break #LI-Remote Veeva s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate I Jul 9, 2025 Navi Mumbai, India, 400706 Who we are The opportunity To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment. To give regulatory support to project teams, stakeholders and other sites, as require How you ll spend your day Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards. Responsibility for MA compliance with both legislation and business needs. Prioritise, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress. Ensure approvals are secured within the stipulated timelines for designated projects. Maintain registration documentation and associated electronic databases, in line with in-house procedures. Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams. Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions. Maintain and develop awareness of current/pending regulatory legislation and guidelines. Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel. Awareness of regulatory legislation and guidelines Your experience and qualifications Qualification: Required Degree: Master in Pharmacy or Master in science/life sciences Experience: Total years of experience required for the role: 2 to 3 years in Post approval Regulatory affairs Overall Pharma industry experience: 2 to 3 years Desirable to have EU experience and knowledge of European regulatory procedures. Reports To Group Leader Regulatory Affairs Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate I Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate I, under direct supervision, is responsible for the preparation and revision of high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2, if required, while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of US FDA labeling regulations and guidances to the level of applying them effectively to all work output in addition to developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents. Establish SPL for assigned projects. Ensure product data elements align with the required drug listing regulations. Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary. Perform quality reviews of labeling and submission documents by proofreading established labeling files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT. Work with Regulatory Operations as well as in Teva s publishing software to ensure assigned projects are submitted on time following the eCTD requirements related to labeling. Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling. Work in a team environment. Perform all other job-related duties as required by management and dictated by process changes. Your experience and qualifications Bachelor s in pharmacy/Master s in science & Life sciences- 2-3 Years in the Pharmaceutical Industry. Master s in pharmacy-1-3 Years in the Pharmaceutical Industry. Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry with a focus on US Gx labeling. Knowledge of SPL development and drug listing requirements. Be able to multi-task in a fast-paced work environment. Have exemplary oral and written communication skills. Be organized with a keen attention to detail. Have the ability to work independently as well as in a team environment with minimal supervision. Have knowledge of US FDA regulations and guidances related to US Gx labeling. Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions. Proficiency in PC and Microsoft Office Suite, including Microsoft Word and Microsoft Excel. Adobe Acrobat Professional is a must. Familiarity with TVT is preferred. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Conduct research and development in pharmaceutical analytics. Develop and implement R&D strategies and plans. Monitor and analyze R&D performance and trends. Prepare R&D reports and presentations. Collaborate with other teams to achieve R&D objectives. Provide training and support to junior R&D scientists. Stay updated with the latest R&D trends and best practices.

we are hiring for Veeva configuration specialist for cognizant for a permanent job in bangalore and pan india location.If interested please share your updated resume to Balaji.V254c1a@cognizant.com Job Description: Title: Veeva Configuration Specialist Location: Chennai Experience: 58 years Grade: SA - Senior Associate Skill Set: Veeva Vault Clinical Operations Suite QMS , Oracle, DB Querying Must-Have Responsibilities: Deep technical expertise in configuring Veeva Vault, especially QMS modules Hands-on experience with Veeva Vault platform configurations Ability to interpret business requirements and design technical solutions Lead design and implementation meetings Review work of other configurators Manage deployments and prepare technical documentation Handle environment management (sandbox refresh, snapshots) Collaborate with Veeva technical teams for issue resolution and feature enhancements Assess technical impact of new releases Guide business decisions and resolution strategies Good-to-Have: Experience in Life Sciences Regulatory and Clinical domains

Apsida Life Sciences has partnered with a leading global CRO, and seeking a Senior Clinical Trial Manager with expertise in Cardiovascular, Renal, or GI trials. This is a career-defining opportunity for professionals who excel in hands-on clinical operations and global trial management. Role Overview Lead multi-country clinical trials, ensuring operational excellence and regulatory compliance Act as the key decision-maker, collaborating with sponsors and cross-functional teams Office-based in India (4 days/week onsite, 1 day remote flexibility) Drive high-impact research in complex therapeutic areas Who Should Apply Education: PhD/MD/MSc in Life Sciences or Medicine (PhD strongly preferred) Experience: 3+ years managing trials in Cardiovascular, Renal, or GI CRO Background: Proven tenure at a top global CRO Career Stability: No more than three jobs in the last six years, with demonstrated career progression Why This Role Elite therapeutic focus on high-impact clinical trials Career growth within a world-class CRO Direct involvement in global clinical research,

The Senior Recruiter is responsible for Service Excellence throughout the recruitment cycle. The Senior Recruiter acts as a brand ambassador for their client and partners with the hiring managers in a consultative capacity. They are focused on delivering top talent for their hiring managers while providing proactive and timely communication on the status of the search. The Senior Recruiter is expected to stay abreast of industry and market specific information or trends that could impact the search. They will act as a mentor to Recruiters as well as other team members. They demonstrate innovation and outside of the box thinking with their search techniques. Work Location: Bengaluru, Karnataka, India Work Arrangement: Hybrid Work Schedule: APAC 1st shift Specific requirements: Min 5-6 years of end to end IT Recruitment preferably in Life Science Industry with Strong Stakeholder Management Experience. Duties and Responsibilities Complete a detailed job scope conversation with the hiring leader to determine position specifications. Timely review of applicants who have applied via the applicant tracking system. Build and deploy effective recruitment marketing campaigns specific to the job opening. Source candidates via resume databases and networking sites using sophisticated Boolean search language. Source candidates via social media channels and deep web sourcing techniques. Generate targeted lists of passive candidates using member subscriptions and technologies. Solicit and pursue referrals from business networks and/or internal referrals. Utilize proprietary software for mobile and email campaigning to talent communities. Use a sophisticated mix of media to connect with talent community (phone, email, campaigning, network introductions and social media). Provide value propositions uniquely tailored to each candidate situation and interest level in the job. Prepare candidates for interviews; providing logistical information, interview schedule, appropriate attire and expectations for follow up from the recruiter; additional counsel as needed. Ensure all candidates are provided with timely updates concerning the status of their applications and interviews. Throughout the process, keeps a strong pulse on the interest levels and/or concerns of top candidates. Conduct professional and thoughtful phone interviews that are infused with industry/role specific probing questions as the conversation/interview dictates. Navigate difficult conversations in order to gather appropriate information. Compare candidate phone interview notes and skills assessments with requisition specifications to determine if the candidate is a match for the role. Apply consideration for factors relative to candidate fit to team and cultural fit. Issue skills testing as needed and evaluate results (if process dictates). Review background and reference information (if process dictates). Keep candidates engaged throughout process. Continuously build talent pipeline to ensure there are multiple candidates in play at all times. Keep hiring manager up to date on any market changes that would impact the hiring process or talent community. Articulate a job offer and drives for candidate acceptance. Partner with the hiring manager to ensure the offer is accepted by the candidate. Strict adherence to all regulations (OFCCP and all other compliance standards set forth). Demonstrate segment/practice/industry expertise. Work to deliver a strong candidate slate for each requisition. Provide accurate and regular reporting of recruiting activities. Identify perceived difficulties with searches and research solutions by collaborating with leadership (and hiring manager as appropriate). Proactively and regularly communicates the status of each search to the hiring manager. Other duties as assigned. Position Requirements Education: Bachelors degree in business, management, human resources or related field required. Equivalent experience may be considered. Experience: Min 5-6 years of end to end IT Recruitment preferably in Life Science Industry with Strong Stakeholder Management Experience. Exposure: Ability to showcase niche segment or industry expertise. Ability to employ technologies in the recruiting process that create efficiencies. Adhere to documentation and processes for compliance. Experience utilizing deep web sourcing techniques.

We are seeking a Sales Head for a Molecular Research and Diagnostic Company. Job Profile: Develop and implement effective sales strategies to achieve company objectives. Analyze market trends and competitors to identify new business opportunities. Prepare and present sales forecasts, budgets, and reports to senior management. Identify and target key markets, institutions, and clients in the biotechnology sector, including pharmaceutical companies, research institutions, and academic labs. Set clear objectives and key performance indicators (KPIs) for the sales team and monitor their performance. Provide training, coaching, and performance evaluations to ensure the team meets sales targets. Foster a high-performance culture by setting clear expectations and providing ongoing feedback. Establish and maintain strong relationships with key customers and industry partners. Develop strategies for expanding the customer base and penetrating new markets. Handle major customer issues and negotiate contracts to secure long-term partnerships. Monitor sales performance metrics and adjust strategies as needed to meet targets. Analyze sales data to identify trends, strengths, and areas for improvement. Report on sales activities, progress, and challenges to senior leadership. Work closely with marketing, product development, and finance teams to align sales strategies with overall business goals. Collaborate with supply chain and operations to ensure timely product delivery and customer satisfaction. Ensure all sales activities comply with legal and ethical standards. Maintain up-to-date knowledge of industry regulations and best practices. Requirements: Required MBA in marketing or equivalent experience Bachelors or Masters degree in a relevant field, such as life sciences, biotechnology preferred. Minimum 7 to 10 years of sales experience in the biotechnology Excellent analytical, strategic planning, and project management skills, with the ability to prioritize and manage multiple projects simultaneously. Strong communication, presentation, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.

Quality Engineer, PMS - Individual Contributor Reports to: Associate Manager, PMQ Trauma & Extremities 1.2 Roles and Responsibilities At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. The Quality Engineer will work on all the various aspects of Post Market Surveillance and enters customer complaints into the company-wide complaint handling system and follows methods to analyze the complaints, for the Trauma & Extremities business. He/She should be competent to compile the Product Safety Usage Reports (PSURs) independently. These activities as they relate to Post Market Surveillance and EU MDR requirements include but are not limited to identifying strategic focus areas for continuous improvements, product/process enhancements, implementing proactive quality activities, monitoring, and measuring the overall performance, and ensuring compliance to quality systems and regulatory requirements. Key Responsibilities include : Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process. Skill Set: Proficient in post market surveillance regulations, specifically EU MDR. Hands on experience of Risk Management process as per ISO 14971 Sound knowledge on complaint trending Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Applied understanding of GDP, ISO 9001 & ISO 13485, FDA 21CFR Part 822 / 820 Additional: Effective interpersonal communications & Excellent analytical skills. Demonstrated organizational and written/verbal communication skills. Drive self-initiative to improve process Ability to work independently and in a team environment 1.3 Desired Profile Education B. Tech / B.E in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar). Experience: 2 to 4 years of experience in Scientific or Medical Writing, and/or Quality and regulatory experience in post market surveillance. Experience with medical device, orthopedic or trauma devices preferred Personality: Proactive, independent, team player with a strong service mentality. You are characterized by analytical and transdisciplinary reasoning, with a good attention to detail. You value an international working environment, working across sites and indications. Based at: SGTC Based at Location: Gurgaon Post Market Surveillance, Pms, Quality

Vision To acquire and maintain global leadership position in chosen areas of businesses To continuously create new opportunities for growth in our strategic businesses To be among the top 10 most admired companies to work for To continuously achieve a return on invested capital of at least 10 points higher than the cost of capital. Head- Engineering Summary of Job Execution of planned maintenance to achieve Zero break down, Zero defect and Zero accident . Key Responsibilities (Performance Indicators) Operation and maintenance of process and utility equipment in shifts. Mechanical maintenance (Preventive, predictive & Breakdown) of process & utility equipment and record keeping. Continuous reduction in down time. Reduction of inventory by standardization and interchangeability of spares. Ensure waste minimization. To prepare daily report of maintenance of respective department. Root Cause analysis of break down, initiate corrective and preventive actions and preparing monthly down time report. To maintain equipment history. Training and development of team members. Life Cycle Analysis of critical equipment. Responsible for adherence to EHS policy. Training and development of team members. To implement of ISO 9000, ISO-14000, OHSAS -18000, TPM. Awareness about responsible care (Environment, Health, Safety and Security) To implement 5S in plant and office. No. of Reportees 1-3 Qualification & Experience BE (Mechanical) with 3-4 years in process / chemical / fine chemical industries. Key Competencies ( Technical, Functional & Behavioral) Strong exposure and hands on experience in equipments used in chemical process plants. / Batch process. Practical experience in maintenance of Glass line equipments and mechanical seals. Knowledge on DCS / PLC based control system. Conceptual knowledge of ISO, WCM, SIX SIGMA and MAXIMO. Knowledge of Safety Standards, use of PPEs Basic knowledge of utilities, refrigeration, steam, cooling towers

Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Creating, validating and executing SAS programs and macros Utilizing SAS programming skills to provide ad-hoc reports (external and internal) Assist in developing programming specifications Assist in creating program specific validation plans Identifying and implementing solutions for complex reporting needs Ensures client data accuracy and integrity by: Creating and/or reviewing data editing and export specifications Working directly with clinical data manager, and where needed with clinical project manager and other team members to ensure specifications are clear and accurate. Has a clear understanding of the contextual requirements for reporting outputs; and provides feedback Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas Programming and testing data export programs in accordance with specific client needs Documenting all programming and validation efforts in accordance with Good Clinical Practices Monitoring data integrity throughout a given study Utilizing SDTM guidelines to create transfer datasets Participating in project meetings (internal and external) Develops and maintains clinical programming standard operating procedures by: Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes Contributing to, designing and maintaining a library of reusable code Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems. Ensures project timelines are maintained by: Working independently and efficiently with minimal input required from the manager. Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of progress as well as potential impediments Maintains Quality Service and Departmental Standards by: Adhering to established processes and standards Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Maintain and review clinical programming SOPs Participating in the modification of company SOPs Secondary Responsibilities Contributes to team effort by: Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by: Attending and participating in applicable company-sponsored training Qualifications: Education: Bachelor s or Master s degree in computer science, life sciences or related field required SAS Certified Professional considered a plus Experience: 3 years SAS programming experience in pharmaceutical related industry required (1 year with Master s degree) Experience working with CDISC, SQL, and Relational Databases preferred Demonstrated programming skills required Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports Proven ability in analyzing data Understanding of medical and/or clinical trial terminology is desirable Proven ability in problem solving Additional skill set: Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-5% Lifting: 0-10lbs Other: Computer work for long periods of time EEO Statement Bioclinica is an equal opportunity employer. Bioclinica 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