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5.0 - 10.0 years
15 - 17 Lacs
Mumbai
Work from Office
YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience. Job location: Sun House, Goregaon East, Mumbai
Posted 1 week ago
6.0 - 8.0 years
6 - 10 Lacs
Bengaluru
Work from Office
About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: To assist pharma regulatory team of Syngene in executing submissions for various licensing activities and follow up with regulators to ensure timely approvals. Role Accountabilities: Preparation and submission of CT-10, CT-12, CT-13, CT-16, Form 12 applications to CDSCO (biological and small molecules), Export NOC, Form 29, GMP, WHO-GMP, license retention, Form 37, COPP, WC and endorsement applications to CDSCO and SLA as applicable. Respond to regulator s queries by collaborating with internal and external stakeholders. Follow-ups for approvals with CDSCO, Zone, SLA and NCB. Filling quarterly returns to NCB and maintain compliance to RCS, 2013. Supporting the team in preparation of IBSC and RCGM application, coordinate and convene IBSC meetings on behalf of member secretary, IBSC. Providing consultation to the internal stakeholders and clients regarding national regulatory requirements as and when required. Maintenance of all submissions and approvals record by maintaining database and trackers. Manufacturing licenses (R&D and commercial), import and export permissions, liaising with State regulators. Providing time to time update to the stakeholders on the licenses and participating in teleconferences/ discussions with stakeholders / clients as required. Prepare new SOPs as and when required, update current SOPs periodically. Keep all operating units updated on recent change in rules and regulations governing product development life cycle. Leadership Capabilities: Maintain a culture of collaboration and team building in the department. Foster behavior for continuous learning and development Clear and precise communication while collaborating with stakeholders. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 6-8 years Demonstrated Capability: Able to make error free submissions and ensure timely approvals. Attention to detail Time management Education: M.Pharma/M.Sc./equivalent Skills and Capabilities 1. Excellent analytical & reasoning skills 2. Good communication (verbal and written) skills 3. Proactiveness and good time management skills 4. Sound working knowledge of national pharma regulatory affairs landscape.
Posted 1 week ago
1.0 - 4.0 years
8 - 12 Lacs
Hyderabad
Work from Office
If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . PRINCIPAL DUTIES AND RESPONSIBILITIES: Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues. Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards. Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific. Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards. Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions. Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.). Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance. Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities. Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors. Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms. Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs. May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions. Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines. Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct. May escalate complex issues for resolution and assist with additional projects or duties as assigned. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS : Bachelor s Degree required; Advanced Degree desirable Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements. In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting). Strong understanding of global regulatory submission guidance. Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs. Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively. Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams. Experience with electronic submissions, specifically eCTD, required. Strong understanding of document management processes in a regulated pharmaceutical environment. Demonstrated understanding of the drug development process and project management experience is highly preferred. Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance. Strong software troubleshooting skills. EOE, disability/veterans
Posted 1 week ago
2.0 - 6.0 years
6 - 10 Lacs
Bengaluru
Work from Office
Position Summary: The Feasibility Manager is a member of the expert team within Feasibility Department of Precision for Medicine. As part of this team, this role has responsibility to support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Feasibility Manager supports pre-award feasibility projects and support business development and operational strategy teams by conducting feasibility analysis. The Feasibility Manager supports stand-alone feasibility projects and site identification and is providing feasibility support for newly awarded and/or ongoing projects. In addition, Feasibility Manager may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients. Essential functions of the job include but are not limited to: Support pre-award feasibility projects Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis. Review clinical protocols, study assumptions, client information and study plans for US and global trials. Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale. Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information. Undertake feasibility site outreach for pre award opportunities. Participate and/or contribute to BDM and client calls. Provide support to post-award feasibility projects Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements. Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery. Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies) Minimum required: Bachelor s degree in a life sciences discipline A minimum of 5 years of related experience Combination of qualifications and equivalent relevant experience may be accepted as an alternative. Other Required: Relevant experience in the required activities for the role including feasibility analysis, site identification. Ability to communicate both verbally and in writing at the English proficiently (Professional level) Preferred: Postgraduate degree preferred. Skills Strong management and organizational skills Excellent oral and written communication skills in English Strong rationale and analytical thinking Strong IT platform and data analysis skills Strong presentation abilities Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms Competencies Strong sense of ownership and pride in quality of outputs Good to strong attention to detail with ability to see the big picture Team player Willingness to work in a matrix environment, work independently and as part of a dynamic team. Demonstrates knowledge of ICH-GCP Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Posted 1 week ago
1.0 - 5.0 years
3 - 7 Lacs
Bengaluru
Work from Office
Job Description Position Summary: The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study. Essential functions of the job include but are not limited to: Support the Quality Management System including SOPs, training and CAPA Process and maintain documentation for controlled documents, as required Develop and administer training for employees and/or consultants Host client/sponsor audits and support regulatory inspections Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted Coordinate and conduct internal audits of quality systems Coordinate and conduct investigator site audits Coordinate and conduct trial master file audits Participate on computer systems validation projects and systems change control process Provide QA consultation and support to assigned project teams internally and externally Support and manage reported quality issues and any associated corrective and preventive actions Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement Maintains Q&C trackers, databases, metrics, and files Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures Additional tasks as required. Qualifications: Minimum Required: 4 years industry experience Clinical research experience in non-QA role considered (e.g., clinical research associate experience) Working knowledge of GCP/ICH guidelines and FDA regulations and standards. Other Required: Bachelor s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative Availability to travel up to 25% domestically and/or internationally. Preferred: CRO, Pharmaceutical and/or Medical device experience QA certification preferred (e.g., CQA, SQA, etc.) Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.) Skills: Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills Competencies Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standards Intermediate proficiency in Microsoft Word, Excel, and PowerPoint Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail Ability to work independently and in a team environment Ability to work with cross functional groups and management under challenging situations Ability to prioritize work and handle multiple and/or competing assignments Results oriented, accountable, motivated and flexible Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Excellent verbal and written communications skills Fluent in English language and for non English speaking countries, the local language of country where position is based Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Posted 1 week ago
4.0 - 5.0 years
6 - 10 Lacs
Noida
Work from Office
Overview about Ripik.AI: Ripik.ai is a fast-growing industrial AI SAAS start-up founded by IIT D/ BITS alumni and with extensive experience in McKinsey, IBM, Google and others. It is backed by marquee VC funds like Accel, Venture Highway and 25+ illustrious angels including 14 unicorn founders. Ripik.ai builds patented full stack software for automation of decision making on the factory floor. Today, they are deployed at more than 15 of the largest and most prestigious enterprises in India including the market leaders in steel, aluminium, cement, pharma, paints, consumer goods and others. It is one of world s very few AI product start-ups to be a partner to GCP, Azure and AWS. We are also the AI partner of choice for CII, ICC and NASSCOM. Roles & Responsibilities: We are looking for a competent and driven DCS Engineer with 4-5 years of experience in Siemens S7- 400 and ABB DCS systems. The role demands hands-on expertise in project development, DCS configuration, system commissioning, and strong knowledge of OT/IT networking and OPC communication protocols. This position will support the execution of industrial automation projects across various process industries. Design, configure, and implement Distributed Control Systems using Siemens S7-400 (PCS7) and ABB DCS 800xA platforms. Develop and review functional and technical documentation (FDS, C&E, loop diagrams, I/O lists, etc.). Configure and integrate HMI/SCADA systems, logic programming, alarms, trends, and historians as required. Lead or support at all stages of the automation project lifecycle: design, development, testing (FAT/SAT), and on-site commissioning. Design and troubleshoot OT (Operational Technology) networks, including layered architectures, VLANs, and segregation between OT and IT zones. Implement and manage OPC (DA/UA/HDA) and other industrial protocols like Profibus, Profinet, Modbus TCP/RTU, Ethernet/IP for PLC-DCS or SCADA integrations. Collaborate with cross-functional teams including instrumentation, electrical, and IT networking teams. Conduct system diagnostics, performance tuning, and provide post-commissioning support. Ensure compliance with project specifications, industry standards, and cybersecurity best practices. Maintain accurate records, backups, and change logs for all DCS-related modifications. Required Skills, Competencies & Experience: Bachelor s Degree or Diploma in Instrumentation, Electronics, Electrical Engineering, or related field. 4-5 years of relevant experience working with: Siemens S7-400 / PCS7 DCS & ABB DCS (800xA Seires). Strong understanding of DCS and PLC architectures, field instrumentation, and process control concepts. Proficiency in industrial communication protocols, especially: OPC DA/UA/HAD, Profibus/Profinet Modbus TCP/RTU & Ethernet/IP. Hands-on experience with OT/IT network architectures, including firewall and switch configurations, IP addressing, and basic routing. Experience in integrating DCS with third-party systems, PLCs, and enterprise-level applications. Ability to work independently on-site during commissioning and troubleshoot control systems. Strong communication skills and a collaborative attitude. Preferred Qualification: Knowledge of cybersecurity in OT environments (ISA/IEC 62443 awareness). Familiarity with SCADA, Historian systems, or MES integration. Exposure to virtualization, server-client architecture, or redundant systems. Knowledge of video analytics, CCTV integration, and industrial automation security. Physical Requirements: Ability to travel to project sites and conduct field inspections. Comfortable working in hazardous industrial environments (oil refineries, chemical plants, etc.) What can you expect? Ability to shape the future of manufacturing by leveraging best-in-class AI and software; we are a unique organization with niche skill set that you would also develop while working with us World class work culture, coaching and development Mentoring from highly experienced leadership from world class companies (refer to Ripik.AI website for details) Location - Noida (Work from Office)
Posted 1 week ago
8.0 - 10.0 years
12 - 16 Lacs
Mumbai
Work from Office
We are looking for an experienced and driven Manager PAS to lead the configuration, implementation, and validation of Scitara s DLX iPaaS platform. This is a customer-facing leadership role ideal for someone with deep expertise in lab informatics systems, a passion for technology in the pharma/life sciences domain, and a strong sense of ownership. You will be a key member of the Services organization, collaborating across product, engineering, and customer success teams to deliver high-impact solutions. Key Responsibilities Lead the implementation and validation of Scitara DLX iPaaS for global pharma and life sciences customers. Participate in customer calls, actively driving discovery, influencing solution design, and delivering value-oriented technical recommendations. Conduct effective product demonstrations and communicate the product s value proposition clearly. Leverage domain and technical expertise to guide the design of scalable, compliant, and robust solutions. Align delivery strategies and technical solutions with Scitara s broader business objectives. Collaborate cross-functionally with Product Managers, Solution Architects, and Software Engineers to ensure smooth handovers and cohesive customer outcomes. Mentor and guide junior team members, fostering a culture of excellence, innovation, and continuous learning. Contribute to technical documentation, internal playbooks, and customer-facing collateral. Champion knowledge sharing, best practices, and internal training within the PAS team. Bachelor s or Master s degree in Computer Science, Life Sciences, or a related field. Minimum of 10 years experience in configuration, implementation, and validation of enterprise lab informatics systems such as LIMS, ELN, LES etc. Desired Skills Strong understanding of the Pharma and Life Sciences domain, with working knowledge of regulatory expectations. Thorough understanding of business processes in the pharmaceutical labs such QC and R&D. Working knowledge and exposure to various LIMS, ELNs and other Informatics applications used in Pharma labs. Working knowledge and exposure to various lab instruments and their governing software, e.g., Empower and controlled instruments, Chromeleon, SoftMax Pro, Tecan Magellan, UNICORN and controlled AKTA Chromatographic instruments, LabX and controlled instruments like pH meters, balances etc. Should be well versed with 21 CFR Part 11, ALCOA+, and GAMP5, GxP regulations. Proven ability to communicate persuasively and influence stakeholders through consultative engagement and value-based storytelling. Experience working in or leading Agile teams. Ability to understand and translate customer needs into technical requirements and collaborate closely with Software Application Specialists. Skilled in balancing technical depth with business alignment; able to contribute to both strategic planning and hands-on delivery. Customer-Centric Mindset: Consultative approach with focus on identifying pain points and delivering tailored solutions. Strategic Alignment: Operates with a strong understanding of Scitara s vision and product roadmap. Domain-Aware Execution: Considers the broader needs of the pharma and life sciences sector in solution delivery. Storytelling & Communication: Communicates complex concepts with clarity and conviction, especially during demos and executive discussions. Exposure to scripting languages (JavaScript, Python), data platforms (databases or data lakes), and cloud infrastructure (especially AWS). Exposure to data standardization models like ASM, AnIML, SiLA. Experience working with monitoring tools, deployment frameworks, or infrastructure automation is an added plus. Capability to align team-level execution with company-wide objectives, while driving performance and operational efficiency. Join a fast-growing, globally recognized platform revolutionizing lab connectivity within the pharmaceutical and life sciences industries. Collaborate with industry-leading experts and innovative thinkers, gaining exposure to some of the brightest minds driving scientific progress worldwide. Contribute directly to impactful scientific innovation, enabling breakthroughs that accelerate research and development on a global scale. Work at the forefront of cutting-edge technologies, including AI-driven laboratory automation and advanced integration solutions. Be part of a transformative movement toward smart labs , leveraging artificial intelligence and automation to redefine how laboratories operate. Engage in projects that shape the future of pharma and life sciences, enhancing efficiency, accuracy, and data-driven decision-making in critical research environments. Experience a dynamic, forward-thinking culture that fosters continuous learning, creativity, and professional growth.
Posted 1 week ago
5.0 - 9.0 years
7 - 12 Lacs
Mumbai
Work from Office
Draft/review contracts, ensure pharma regulatory compliance, handle IP matters, represent company in legal proceedings, develop risk management strategies, and support audits/investigations. Strong negotiation, communication, and analytical skills. Required Candidate profile LLB degree, 5+ yrs corporate law exp (2+ yrs pharma/healthcare). Expertise in pharma regulations, contracts, IP, and litigation. Apply on : 8591061941 sunidhi.yadav@cygnusad.co.in
Posted 1 week ago
5.0 - 9.0 years
7 - 12 Lacs
Mumbai
Work from Office
Draft/review contracts, ensure pharma regulatory compliance, handle IP matters, represent company in legal proceedings, develop risk management strategies, and support audits/investigations. Strong negotiation, communication, and analytical skills. Required Candidate profile LLB degree, 5+ yrs corporate law exp (2+ yrs pharma/healthcare). Expertise in pharma regulations, contracts, IP, and litigation. Apply on : 8591061941 sunidhi.yadav@cygnusad.co.in
Posted 1 week ago
8.0 - 10.0 years
20 - 25 Lacs
Mumbai
Work from Office
Position will be responsible for QA function. Develop, implement and maintain the Quality Management System (QMS) at Scitara. Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements and establish the training function within Scitara. Key Responsibilities Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements. Responsible for authoring, reviewing and approving Standard Operating Procedures, Work Instructions, Policies, Manuals and Guidance documents for Scitara. Represent Scitara in customer audits, regulatory inspections and certification audits (ISO 27001 and SOC II Type 2). Responsible to ensure education and awareness about audit / inspection readiness in the organization. Impart training on SOPs and regulations. Manage CAPAs and deviations at an organizational level. Ensure that software systems meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). Provide QA oversight for all phases of validation (planning, testing, deployment, and change control). Review and approve validation deliverables (e.g., Validation Plan, Test Plan, Test Scripts, Traceability Matrix, Validation Summary Report). Implementing the data privacy policies and associated processes in Scitara across functional units. Bachelor s or Master s degree in appropriate field of study. IT CSV QA candidate with 08-10 years experience in QA, IT and Computer System validation with some background of Software Development. Expertise in validation principles and validation types, software development best practices, and quality management systems used in the FDA/MHRA/EMA regulated environments is required. Preferably, candidates who have worked / supported Pharma / Life Sciences companies. Desired Skills Knowledge and understanding of GxPs and other governing regulations, both local and international. Understanding of quality systems processes and their implementation.
Posted 1 week ago
2.0 - 6.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. About the position: Market Development Manager, Urology Your Responsibilities will include: Meet or exceed the assigned therapy development objective for each therapy category while maintaining expenses within assigned expense limits. Achieve Personal & Support the Uro lines of business and help organization achieve the desired sales objectives. Work cooperatively with respective Sales personnel for comprehensive and optimum coverage (pre-decided accounts for each quarter per therapy)and product portfolio bundling opportunities Establish and maintain positive and cooperative working relationships with customers, conducting his or herself in a professional and responsible manner at all times. Conduct / hand-hold sales team for successful technology-based Physician/ Technician Training Programmes , Product demonstrations , In-Service programs to ensure optimum utilisation of the Therapy. Conduct analysis of competitor activities, customer needs, technology and infrastructure, therapy adoption etc. relevant to own products in-country in order to analyze impact of market conditions, guide local franchise operations teams, report back to the regional team & highlight possible modifications to the regional/ franchise marketing plans. Work along with Sales Team & Service Engineer/s to sign AMC/CMC with all installations and help generate revenue stream especially for relevant technologies in Urology. Work with Centre of Excellence for each Therapy Area to optimize on targeted therapy development and advance lead funnel. Drive applications & penetrations of assigned equipment primarily in all BSC installations in a planned way as per targets. This will include training account manager/s, technicians, physicians on Patient Selection , Procedure Preparedness, Successful Procedure, Tracking Outcomes & Collecting Involve in clinical discussion with the suggested Urologists as suggested by Sales Team regarding the technical specifications of the capital equipment. Establish relationships with KOLs in the field; Identify key Physician champions for franchise; Develop support structure and relationship with sales representatives and sales management. Assist the marketing team in formulating strategies, tactics and action plans to engage / advance segment-wise customer. Co-develop and partner in implementation of marketing programs according to plan and budget with Sales & Marketing Teams. Work with Marketing Team in establishing, monitoring and drive clinical message related the therapy. Work with the team to identify opportunity in potential accounts as defined in strategic map for capital equipment and work with all stake holders to close the deals. Work closely with the tender management team to ensure that we can lock in tenders with our specifications and win. What were looking for in you: Bachelor s degree in business or sciences and at least 5 years of medical device/ pharmaceutical therapy development. Track record of quota attainment selling high-value products to multi-level decision-makers. Existing relationships within the healthcare hospital industry/ KOLs. Strategy development, project management, problem solving, and change management skills. Solid understanding of healthcare and regulatory requirements and issues. Understanding of OT Environment and working within the regulatory requirements, ensure safety of patients / HCPs / self and other stake holders. Exceptional Communication Skills to effectively communicate therapy related information. Ability to build positive working relationships, both internally and externally. Ability to effectively present information and negotiate with all levels of management including CFO, CIO, CEO, CMO as and when required. Clinical aptitude in Urology. Requisition ID: 607052 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Posted 1 week ago
10.0 - 12.0 years
20 - 25 Lacs
Mumbai
Work from Office
Job Summary: The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and drafting critical responses to new product queries and legal matters. Key Responsibilities: Develop and implement overall regulatory strategy for new products. Manage the life cycle of existing products, ensuring compliance with regulatory requirements. Conduct SEC meetings and ensure all regulatory submissions are accurate and timely. Draft critical responses to new product queries and legal matters. Collaborate with cross-functional teams to ensure regulatory compliance and support product development. Monitor changes in regulatory requirements related New products and communicate their impact on the company s products and processes. Provide regulatory guidance and support to internal teams and stakeholders. Qualifications: Bachelors / Masters degree in Regulatory Affairs, Life Sciences, or related field. Advanced degree preferred. Minimum 10-12 years of experience in regulatory affairs Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to manage multiple projects and deadlines. Detail-oriented with strong analytical and problem-solving skills.
Posted 1 week ago
2.0 - 3.0 years
4 - 5 Lacs
Bardhaman
Work from Office
The incumbent will be responsible driving the secondary sales and merchandizing by building and developing long term relationships with the retailers Key Stakeholders: Internal Marketing, Supply Chain, Human Resources, Sales Development Key Stakeholders: External Retailers, Wholesalers, Distributors, Key Accounts customers Reporting Structure: Will report to Sales Officer Experience: 2-3 year of sales experience in FMCG/Pharma/OTC industry preferred in channel management Product understanding Negotiation Good local geographical Knowledge Local Language fluency Distributor Management Basic Calculation of retail scheme/ distributor scheme Graduate / MBA Cover Superstore outlet in the respective territory Achieve assigned monthly Target Responsible for New Outlet Opening Responsible for New Product Launch Manage the performance of superstore channel to improve our sales revenue. Ensure POB conversion into secondary sales with DMS execution Mobile reporting (Attendance Sales) on daily basis Responsible for repeat frequent order from outlets Responsible for merchandising store branding Develop Maintain strong relationship with channel Partners.
Posted 1 week ago
10.0 - 15.0 years
20 - 25 Lacs
Bengaluru
Work from Office
As a Principal Data Engineer at Alexion, you will be at the forefront of developing cutting-edge data integration solutions that cater to the dynamic needs of our global data platforms. Your expertise will be pivotal in designing, implementing, and managing robust data pipelines and integration paradigms. Collaborate closely with diverse IT teams to support data-driven decision-making and strategic initiatives. Your mission will be to build scalable, reliable, and resilient data solutions, enhance data quality and observability, and ensure compliance with industry standards and regulations. Become an advocate for data governance and best practices, empowering Alexion to leverage its data assets for business innovation and success. Accountabilities: Develop and maintain high-quality data integration solutions to support business needs and strategic initiatives. Collaborate with IT teams to identify data needs, structure problems, and deliver integrated information solutions. Ensure the quality and security of Alexion s data through the implementation of best practices in data governance and compliance. Stay abreast of industry trends and emerging technologies to drive continuous improvement in data engineering practices. Essential Skills/Experience: masters Degree in Computer Science, Information Systems, Engineering, or a related field. A minimum of 10 years of experience in data engineering, data management, and analytics. Proven track record of delivering large-scale, scalable, secure, and robust data solutions in the pharmaceutical or life sciences industry. Strong experience with SQL, Python, ETL/ELT frameworks, and building data orchestration pipelines. Expertise in cloud architectures, particularly AWS. Proficiency in Snowflake and its features (resource monitors, RBAC controls, etc), dbT, Fivetran, Apache Airflow. Strong analytical, problem-solving, and organizational skills. Ability to effectively communicate complex data insights and solutions to diverse audiences, including senior leaders. Advanced understanding of data warehousing methodologies and data modeling techniques (Kimball, 3NF, Star Schema, ). Understanding of data governance, compliance standards (GDPR, HIPAA), and FAIR and TRUSTED data principles. Desirable Skills/Experience: Extensive experience (5+ years) within the biotech/pharma industry. Familiarity with Kubernetes, Docker/containerization, and Terraform. Knowledge of data quality and observability tools and methodologies to enhance data reliability.
Posted 1 week ago
7.0 - 12.0 years
14 - 19 Lacs
Bengaluru
Work from Office
As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). you'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: bachelors Degree (Minimum) or masters Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.
Posted 1 week ago
2.0 - 5.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Creation, development and maintaince of dashboards and performance metrics using Business Intelligence tools (eg., PowerBI, Smartsheet, Plai, ValueLens, etc) Development of, and managing/tracking of operational progress and performance metrics (eg, planning and resource analytics) for KPI analysis and other performance measures Development of and managing/tracking of tools for Portfolio or non-pipeline projects and other key business processes Develop dashboard specifications in close collaboration with stakehodlers and manage UAT on delivered dashboards Strengthen the current reporting activities and support cross-functional department by addressing their specific needs and questions needed for decision-making Work with the various disciplines within R&D to improve the quality and standards of reported data throughout the data sources Provide the necessary Tool training to stakeholders (user, analytics and reporting) Experience: Experience in Pharmaceutical industry, and experience in R&D or in Business Soft skills : Strong interpersonal and communication skills. Ability to interact and build strong relationships with project teams and support functions within R&D Willingness to work as a team, in a global and matrix organization Ability to challenge status quo and propose new ideas. Technical skills : Planisware / Agile method / Development in PowerBI - Tableau - Power Platform Education : Masters degree Languages : English
Posted 1 week ago
2.0 - 3.0 years
4 - 5 Lacs
Kupwara, Jammu
Work from Office
The incumbent will be responsible driving the secondary sales and merchandizing by building and developing long term relationships with the retailers Key Stakeholders: Internal Marketing, Supply Chain, Human Resources, Sales Development Key Stakeholders: External Retailers, Wholesalers, Distributors, Key Accounts customers Reporting Structure: Will report to Sales Officer Experience: 2-3 year of sales experience in FMCG/Pharma/OTC industry preferred in channel management Product understanding Negotiation Good local geographical Knowledge Local Language fluency Distributor Management Basic Calculation of retail scheme/ distributor scheme Graduate / MBA Cover Superstore outlet in the respective territory Achieve assigned monthly Target Responsible for New Outlet Opening Responsible for New Product Launch Manage the performance of superstore channel to improve our sales revenue. Ensure POB conversion into secondary sales with DMS execution Mobile reporting (Attendance Sales) on daily basis Responsible for repeat frequent order from outlets Responsible for merchandising store branding Develop Maintain strong relationship with channel Partners.
Posted 1 week ago
3.0 - 7.0 years
5 - 9 Lacs
Hyderabad
Work from Office
Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Collaborate with internal/external stakeholders viz Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management, Contract manufacturing organization. Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints. Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines. Ensure investigation management and coordination with internal and external partners (including tracking and monitoring of investigations). Review & closure of investigation reports to ensure correctness, completeness, and adherence to standards including root cause analysis, CAPA, assessment and prioritization. Collection, visualization & analysis of complaint data. Preparation of trend reports of complaints related to products, sites, EMS & Countries defined as per procedure. About you: Experience: 3 - 7 Years Experience. Education: Graduate in Pharmacy or life sciences or Engineering or Biotechnology. Languages: English, Hindi is preferred Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention, and we'llness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowe'red to propose and implement innovative ideas.
Posted 1 week ago
8.0 - 13.0 years
9 - 13 Lacs
Hyderabad
Work from Office
The primary role of Sales Professionals function is to sell ResMeds products to customers and/or professional organizations through various distribution channels. Key deliverables include planning, positioning and strategic marketing of ResMed s full range products and services in the allocated region. Attaining sales objectives for new and existing accounts within the assigned distribution or retail sales channel. Responsible for new account development and/or expanding existing accounts thereby maximizing turnover and profit margin. Let s talk about the role The primary objective of Direct Field Sales specialization within Sales Professionals is to market, sell, promote, and grow revenue in all product categories. Works closely with the sales management team in evaluating business conditions and sales trends. Develop and enhance business relationships through routine consultative customer visits, product demonstrations, educational programs, product in-services, and problem resolution. Identify and develop new customer base or work to find opportunities to introduce additional ResMed solutions to existing customers. Takes ResMed products and services to external customers or groups of customers and enters into commercial negotiations for purchase and supply. Requires knowledge of ResMed offerings and customer needs. Sales roles typically require a university degree of equivalent work experience. Networks with senior internal and external personnel in own area of expertise. Normally receives little instruction on day-to-day work, general instructions on new assignments. Let s talk about you bachelors degree. Minimum of 8 years of related experience within Medical Device OR Pharma industry A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Should Have prior experience managing the region. Its beneficial to have prior experience in at least one therapy area, such as Respiratory, Sleep Medicine, Cardio-Metabolic, or Diabetes.
Posted 1 week ago
1.0 - 3.0 years
1 - 3 Lacs
Ahmedabad
Work from Office
Comply with World Courier Standard Operating Procedures (SOP), which contain specific instructions to take the steps concerning the reception and shipment of materials Compare the material received with the documentation forwarded in order to certify concordance or disagreement Prepare box contents according to what s described on WC Packing List The Operator must have the training and the capability required to control materials characteristics (described in their labels): ID number, expiration date, patient s kit, and temperature and storage conditions as we'll as any additional information that could be useful The Operator must be specifically trained in order to perform activities related to shipments such as the packaging preparation, box closing and labeling Perform activities on the Operative System CTM-STAR related to the Inbound, Outbound, Return and Relocation processes Have deep knowledge and carry out relabeling, stock, balance and relocations processes developed at the Facility Perform any other duties the employee has been trained for Requirements: English language - B2-C1 Gujarati language - native - C1 Experience in logistics /warehouse/operations - will be a plus Computer skills Adaptability to working hours: Monday to Saturday Good communication skills Pleasant proactive manner Attention to detail Initiative and commonsense Reliable and accountable Ability to work in a team environment
Posted 1 week ago
1.0 - 3.0 years
10 - 14 Lacs
Panipat, Yamunanagar, Faridabad
Work from Office
Today Lonza is a global leader in life sciences. While we work in science, there s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that s the kind of work we want to be part of. Lonza s Capsules Health Ingredients business is the trusted partner for innovative products, including capsules and health ingredients, customization services and end-to-end dosage form solutions for pharmaceutical and nutraceutical companies. We are hiring a driven Global Controls Engineer to enhance innovation and implement sophisticated technologies in our CHI operations. Key responsibilities: Responsible for development, replication, modifications and support of global automation systems which are used at sites in India. Implement and support global initiatives, while applying advanced and specialized (PLC/SCADA/Simotion) software engineering competencies, including knowledge of software development life cycle and common deliverables such as system requirements. Build test plans to verify software fitness for use; Carries out commissioning and supports validation of control systems; Develop accurate time estimates for control software development tasks; Act as liaison between RD and production site automation (control systems) engineers/maintenance. Support the management in providing a climate, that stimulates and motivates colleagues to participate in preservation of environment, and in protection of health and safety of colleagues. Design modifications to existing automation systems based on process diagrams, user requirements, functional requirements, Piping Instrumentation Diagrams (PID), machine mechanical drawings. Key accountabilities: Designs modifications to existing automation systems based on process diagrams, user requirements, functional requirements, Piping Instrumentation Diagrams (PID), machine mechanical drawings. Collaborates effectively with global automation engineering colleagues on development projects, standards development, selection and implementation of new technologies and automation systems. Supports, configures and replicates (including new releases and patching) PLC systems, SCADA, drive configuration, servo systems, and vision systems. Maintains software and hardware global configuration information, technical documentation, software backups, control software revision notes, knowledge base data records, generates FS/DS documentation and supports cGMP validation process. Regularly communicates with Global Controls Engineering Manager, colleagues, and with site maintenance, engineering, production, QA on project progress and potential issues. Based on a rotating schedule provides after-hours support for plant operations. Effectively collaborates with plant personnel, provides technical guidance. Key requirements: Master of Science or Master of Engineering (field of Study: Electrical Engineering / Mechatronics / Computer Science / ME / Robotics all with emphasis on automation) Proficient in English Ability to work independently, as well as in team environment, and open to guidance from senior colleagues Strong project development, implementation, and interpersonal skills; Highly organized and detail oriented. Proven experience in manufacturing environment
Posted 1 week ago
5.0 - 10.0 years
10 - 11 Lacs
Jamnagar, Ahmedabad, Rajkot
Work from Office
About Us We are a specialty chemicals manufacturing company with a full stack solution from R&D to manufacturing and doorstep delivery of innovative chemicals. Headquartered in Bengaluru, India we cater to pharmaceutical, agrochemical, industrial chemicals, personal care, dyes & pigments and home care industries. Our B2B fulfillment platform supports businesses globally in developing and manufacturing chemicals from lab to commercial scale. With a team of in-house R&D experts and scientists, we offer custom synthesis and route scouting services to support manufacturers in product development. We are VC backed - here is a read. We are 200+ people strong and have offices in India, UAE and Indonesia. We are currently exporting to over 17 countries from India currently. Job Description We are looking for P&L Owners to drive Specialty Dyes, Pigments and Intermediaries Portfolio. This role will be responsible for end-to-end ownership of Business- Develop a vision for the business and execute it, Product portfolio selection, Sales in global and domestic markets, Strategic sourcing, evaluating manufacturing, driving product development and R&D, Building and Mentoring teams. Location Maharashtra or Gujarat Key Responsibilities We are a team of entrepreneurs- with extreme ownership and drive to build a business which will outlast our careers. Looking for someone with the same attitude Identifying potential products, building supply chains across it and driving revenue by developing market/potential customers globally. Own the entire go-to-market process. Exploring opportunities for product innovation and improvements and work with vendors/labs to bring them to life. Evaluate and negotiate with contract manufacturers, joint venture partners, and tech collaborators. Willingness to travel - be with the customer to build a relationship, understand his/her pain points and evaluate/establish vendors and manufacturing plants. Establish metrics to measure system performance and business value Develop a roadmap for continuous improvement and future system enhancements Qualifications Minimum of 5 Years of experience in Business development in Dyes & Pigment industry If you are a startup enthusiast and like working with fast paced and high growth teams, join the team.
Posted 1 week ago
12.0 - 15.0 years
11 - 16 Lacs
Tumkur
Work from Office
12 to 15 years from API / Chemical / Pharmaceutical Manufacturing Knowledge: ob Role Ensure adherence to Environmental, Health, and Safety (EHS) policies and legal requirements Checking and issuing of Permit to Work (PTW) Organize Safety Committee, Fire Drill, Mock Drill, Monthly Plant Safety Inspection( PSI) Audits Daily monitoring and maintenance of Fire hydrant, FAS, Sprinkler, Smoke Detectors & PA system Reporting of UA/ UC Activities & Implement CAPA, reported issues incident, accident, or near-miss reports preparation Should have experience in HIRA, HAZOP, QRA, JSA, PSSR Studies Preventive maintenance of Eye & Body wash showers, Spill control kits, Fire Extinguishers etc Knowledge on PESO, Gas Bank Stations, LN2, Non-PESO Solvents rules and regulations Knowledge on Testing & Inspection of Hoist & lift, Lifting tools & Tackles, Pressure plant/vessels Knowledge on Application preparations, renewals of Fire NOC, OSEP etc Prepare, review, and update the Safety and Environment Related SOPs Actively Conducting the On-site ( As per schedule) & Off- Site Emergency exercise in coordination with line function and mutual aid team Witnessed by Asst Directories of Factories & Boilers End-to-End operations, troubleshooting, Operations, and cost control of ETP, STP, UF, RO, MEE & ATFD Timely submission of Monthly, Half yearly and All Annual Reports to Pollution Control Boards (SPCB) and Central Pollution Control Board (CPCB) Safe Handling & Disposal of Hazardous waste, Biomedical waste, Battery, and E-waste Should have knowledge on SCADA, PLC, and HMI systems related to MEE & ATFD, UF and RO Prepare and submit the ESG& ESAP monthly data, Impact reports Strong knowledge of EHS laws and regulatory frameworks (Factories Act, PESO, CPCB/SPCB norms) Risk management & safety audit experience Emergency preparedness and crisis management Familiarity with automation and instrumentation systems in effluent management Strong documentation, reporting, and compliance tracking skills
Posted 1 week ago
1.0 - 4.0 years
7 - 10 Lacs
Hyderabad
Work from Office
Career Category Finance 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. What you will do Let s do this. Let s change the world. In this vital role you will be responsible for the month-end close and controllership activities for specific countries in the ELMAC region (Europe, Latin America, Middle East, Africa, and Canada). Besides that, you will support the Sr. Managers with the successful delivery of strategic, tactical, and general accounting controlling goals. In this role, will also be under your responsibility performance of balance sheet reviews in liaison with outsourced partners/Finance and Administration team at the ELMAC affiliate, as well as the control validations and testing (IICC/SOX). Roles Responsibilities: The Senior Associate accounting will be responsible for several activities including but not limited to the following: Be responsible for accurate, complete, and timely periodic accounting close for ELMAC. Support the preparation of close packages (including variance analysis), and disclosure checklist. Operate as a link between local, regional, and functional finance teams establish clear roles responsibilities, and install the appropriate processes and tools. Support and advise local Finance leads with Tax compliance, internal and external audits as well as the implementation of recommended improvements. Create and track financial metrics as part of a dashboard for management. Provide ad hoc support to the Accounting Director and flag all opportunities and challenges. Keep track of the effectiveness of SLAs, process maps, and SOPs, and monitor the various Finance functions. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 3+ years of Finance experience. Bachelor s degree and 6+ years of Finance experience. Knowledge of financial management and accounting principles. Strong understanding of compliance and regulatory requirements. Experience with ERP systems and financial software. Financial experience in a global, multi-site corporation Preferred Qualifications: Advanced degree in finance, accounting, or MBA. Chartered Accountant (Certified public accountant), CMA, CFE or other professional. certification relevant to the accounting profession. Extensive accounting experience. Ability to manage multiple competing priorities in parallel. Familiarity with the pharmaceutical/biotech industry. Experience with global finance operations. Proficiency in data analytics and business intelligence tools. Finance transformation experience involving recent technology advancements Prior multinational capability center experience Experience with SAP (ECC and/or S4), Blackline, Workiva, Tableau/PowerBI Soft Skills: Strong communication and interpersonal skills. High level of integrity and ethical standards. Problem-solving and critical thinking capabilities. Adaptability to a dynamic and fast-paced environment. Strong organizational and time management skills. Ability to manage multiple competing priorities in parallel. 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 and make a lasting impact with the Amgen team. 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. .
Posted 1 week ago
4.0 - 8.0 years
9 - 13 Lacs
Hyderabad
Work from Office
Career Category Human Resources Job Description At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission to serve patients has driven our status as one of the world s preeminent biotechnology companies, reaching over millions of patie nts worldwide. Now, we re building a bold new talent capability that will shape the future of our global workforce and help us attract, understand, and engage the world s top scientific and executive talent. Live What you will do We are seeking a Talent Intelligence Lead ( Senior Manager ) to build and lead Amgen s newly established Global Talent Intelligence function. This strategic role sits within our Global Talent Acquisition team and will be central to shaping how Amgen uses data, technology, and insights to anticipate future workforce needs, proactively map markets, and enable executive and strategic hiring across regions. You will be responsible for launching and managing a team that connects real-time labor market insights, predictive analytics, and global talent mapping to key executive and business priorities in full alignment with the strategic direction enterprise leadership . This position will work closely with leaders across HR, Executive Search, and Workforce Planning to build a best-in-class capability, leveraging platforms such as Workday, Eightfold CRM, LinkedIn Talent Insights, and other leading intelligence tools. Key Responsibilities Include: Talent Intelligence Strategy : Build and lead a scalable global talent intelligence capability, enabling strategic hiring decisions with data-driven insights, trends, and forecasts. Executive Talent Mapping : Develop frameworks to proactively identify and track key executive talent across biotech, life sciences, and pharma industries in alignment with strategic priorities. Global Market Insights : Deliver deep labor market analyses and benchmarking reports to inform location strategies, skills availability, and hiring feasibility. Pipeline Development : Collaborate with Strategic Sourcing to inform proactive pipelines and candidate nurturing strategies across critical job families and executive roles. CRM Talent Data Infrastructure : Partner with TA Tech and Platforms to build tagging structures and segmentation strategies that enable scalable and actionable CRM engagement. Stakeholder Partnership : Serve as a trusted advisor to Talent Acquisition, HR Business Partners, and senior leadership by translating complex talent data into clear, actionable recommendations. Innovation Enablement : Champion the adoption of new technologies , tools, and intelligence platforms to maximize efficiency and impact. Capability Building : Lead and mentor a high-performing team of talent intelligence professionals; foster a culture of curiosity, continuous learning, and operational excellence. Win What we expect from you Bachelor s degree in Business, Human Resources, Data Analytics, or related field. Total professional experience of at least 14 years, demonstrating a strong foundation across Human Resources or related domains. Minimum of 7 years of progressive experience in Talent Intelligence, Strategic Sourcing, Executive Search, or Talent Strategy, preferably in a large, global organization. Experience launching or scaling a talent research or labor market insights function with direct impact on strategic hiring. Familiarity with tools such as Workday, innovative CRM technologies, LinkedIn Talent Insights, TalentNeuron , or equivalent market intelligence platforms. Strong analytical mindset with the ability to convert data into meaningful stories, dashboards, and strategic outcomes. Experience with CRM segmentation, candidate lifecycle marketing, and passive talent engagement strategies. Demonstrated ability to influence and consult across senior levels of the organization. Excellent communication, project leadership, and change management skills. Proven experience managing and mentoring a small team or building new capabilities from the ground up. Thrive What you can expect from us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. We offer competitive annual base salary, and a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. .
Posted 1 week ago
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The pharmaceutical industry in India is one of the largest in the world, with a high demand for skilled professionals across various roles. Job seekers looking to enter or progress in the pharma sector in India have a plethora of opportunities to explore. In this article, we will delve into the pharma job market in India, highlighting top hiring locations, average salary ranges, career progression paths, related skills, and common interview questions for pharma roles.
These cities are known for their significant presence of pharmaceutical companies and research institutions, making them hotspots for pharma job opportunities.
The average salary range for pharma professionals in India varies based on experience and job role. Entry-level positions such as Research Associate or Quality Control Analyst can expect a salary range of INR 3-5 lakhs per annum, while experienced professionals like Research Scientists or Regulatory Affairs Managers can earn between INR 8-15 lakhs per annum.
In the pharma industry, a typical career path may involve starting as a Junior Research Associate or Quality Control Analyst, progressing to roles like Senior Research Scientist or Quality Assurance Manager, and eventually reaching positions such as Research Director or Head of Regulatory Affairs.
In addition to expertise in pharmaceutical sciences, professionals in the pharma industry may benefit from having skills in regulatory affairs, quality management, data analysis, project management, and compliance.
As you navigate the dynamic and rewarding field of pharma jobs in India, remember to stay informed, hone your skills, and approach interviews with confidence. With the right preparation and mindset, you can seize exciting opportunities and advance your career in the thriving pharmaceutical industry. Good luck!
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
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