ResponsibilitiesSponsor Oversight & Accountability: Maintains documented Sponsor Oversight frameworks, ensuring appropriate oversight of CROs, vendors, and investigational sites based on trial complexity, risk, and criticality of activities. Ensures that delegation of trial activities does not absolve Sponsor accountability, and that oversight mechanisms remain effective throughout the trial lifecycle. Provides independent assessment and escalation of quality risks, compliance gaps, and emerging signals to appropriate governance bodies. Supports senior leadership in demonstrating active Sponsor oversight during audits and regulatory inspections Provides quality oversight of CROs, vendors, and partner organizations, assessing performance against contractual obligations, quality expectations, and regulatory requirements. Integrated Quality Control (IQC) Activities: Plans, leads, and conducts risk-based IQC activities, including: In-house process and documentation risk-based IQC reviews Remote and on-site QC visits Focused reviews of high-risk processes, data, vendors, and sites Ensures QC activities provide independent verification of trial conduct, data credibility, and compliance with protocol, SOPs, and regulatory requirements. Documents QC outcomes clearly, ensuring traceability, inspection readiness Risk-Based Quality Management (RBQM): Leads RBQM in accordance with ICH E6(R3), ensuring quality is proactively planned, implemented, monitored, and improved throughout the trial lifecycle. Supports study teams in identifying Critical-to-Quality (CtQ) factors, including critical data, processes, and endpoints impacting subject safety and data reliability. Contributes to the development and maintenance of study-level risk assessments, Quality Management Plans, and oversight strategies. Performs ongoing risk review and signal detection using QC findings, metrics, KPIs, KRIs, centralized monitoring outputs, and trend analysis. Ensures that quality actions are risk-proportionate, focused on preventing issues rather than detecting errors retrospectively.Qualification & ExperienceAdvanced degree in Medicine/Pharmacy/Life Sciences; Master’s preferred. 10+ years’ global clinical research experience, including sponsor oversight and on-site monitoring of multi ? centric trials. Strong expertise in ICH ? GCP, global regulations, and sponsor accountabilities.

ResponsibilitiesAchieve territory sales targets (value, volume, and product-mix goals) with disciplined forecasting. Improve account coverage and frequency, resulting in measurable growth across priority institutions and channels. Strengthen distribution health (availability, visibility, liquidation, and inventory hygiene). Build robust pipeline of new accounts and institutional opportunities (tenders/contracting where applicable). Execute brand strategy and promotional plans while maintaining 100% compliance with company policies and local regulations.Own an assigned territory to deliver monthly/quarterly/annual sales targets across Baxter’s pharmaceutical portfolio. Map the territory: identify high-potential accounts, prescribing influencers, buying points, and referral networks. Drive call planning and coverage routines (daily plan, weekly route, monthly coverage dashboard). Build relationships with key stakeholders: Hospitals/institutions: purchase, pharmacy, ICU/OT, anesthesia/critical care teams (as relevant to portfolio) Clinics and prescribers (where permissible) Channel partners: distributors/stockists/wholesalers Create and maintain account plans (objectives, stakeholder map, barriers, action plan, timelines).Qualification & ExperienceGraduate in Life Sciences / Pharmacy / Business preferred (MBA/PGDM is an advantage) Up to 8 years of field sales experience in pharmaceuticals / critical care / hospital/institutional sales preferred Strong understanding of: Institutional selling process and channel dynamics Distributor management and secondary sales concepts Compliance-led field execution in a regulated industry

Responsibilities Design, implement, and maintain a global clinical inspection preparedness framework across GDO asset programs in collaboration with cross?functional stakeholders.  Partner with the VP and Head of Development QA to define inspection readiness KPIs and contribute to governance reporting, dashboards, and risk monitoring activities.  Drive ongoing preparedness activities, including mock inspections, gap assessments, and targeted readiness health checks.  Embed inspection preparedness throughout the clinical trial lifecycle, including start?up, conduct, and close?out phases.  Serve as the primary inspection readiness lead for Health Authority inspections at the Princeton, NJ site and partnering closely with regional inspection teams at global facilities.  Oversee inspection preparation, execution, and follow?up activities, including document readiness, inspection logistics, and SME preparation and coaching.  Lead inspection response activities, including daily debriefs, Health Authority interactions, post?inspection commitments, and CAPA development and tracking.  Identify systemic inspection risks and lead mitigation, remediation, and continuous improvement initiatives.  Ensure timely and effective completion of inspection?related CAPAs and audit actions, monitoring effectiveness and sustainability.  Communicate inspection risk, compliance posture, and readiness status to key stakeholders and senior leaders.  Facilitate cross?functional forums, training sessions, and lessons?learned workshops in partnership with project management colleagues.  Contribute to inspection/audit oversight of CROs, vendors, and other external partners to ensure preparedness.  Develop and deliver inspection preparedness training and coaching for internal teams, clinical sites, and designated SMEs.  Support onboarding and ongoing inspection preparedness education for new programs and personnel Qualification & ExperienceBachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; Master’s degree preferred.  Experience  Significant experience in Clinical Quality, Clinical Operations, and/or Regulatory Compliance.  Direct and recent experience supporting or leading global GxP regulatory inspections.  Strong working knowledge of GxP regulations, ICH guidelines, and global inspection processes and CAPA. 

ResponsibilitiesAggregate Safety Report (PSUR/ PBRER/ PADER) related activity Responsible to provide PV support for new submissions and Post approval activities for Pharma Segment RFI Evaluation, Authoring Support activities (ASG) for PSUR/ PBRER/ PADER and ACO scheduling and submission Review and preparation of PADER/ PSUR/ PBRER, coordination for their submission as per schedule Handling of request received from central and local regulatory affairs and PV department with respect of timeline RMP Related activities Assist in developing RMP and allied activities Coordinate with Global RMP team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates

ResponsibilitiesMonthly account wise planning of secondary sales leading to primary sales for their territory/accounts Weekly planning for coverage and calls Monthly/quarterly sales forecast for defined territory Quarterly activation planningDrives adherence to SFE processes: Call average, customer coverage, working days, SME trackers, prescription tracker, secondary sales and product sampling/demonstrations To track all product and service quality related complaints and coordinate with National/Sales Manager/quality to ensure formal response and closure to complaints report it to PV & Quality Competition & Market Mapping -- Track and gather market data, no. of indicated surgeries, gather and analyze competitor activities P5 Implementation – Implementation of Marketing strategy and activations as per defined GTM Identify and drive business development initiatives in his/her current /new accounts including training and education of paramedical staff Ensure speedy and adequate availability of products in his/her accounts

Responsibilities Responsible for maintaining GLP, GMP and Data Integrity in quality control department.  Review of SOP’s and STP’s of QC department.  Allotment of day to day work to team members and work planning.  Identifying training needs of the staff in the department.  Ensuring that all Analytical instruments are in good working condition and timely completion of AMC/CMC.  Release ( Approve/Reject) of Raw material, Packing material ,In process, Intermediate and Finished product.  Timely release of Raw material, Packing material ,In process, Intermediate and Finished product as per procedure to support smooth production.  Up keeping the laboratory all time ready for regulatory and customer audits.  Review and approval of stability protocol and stability data generated time to time.  Ensuring preparation of AMC/CMC and Calibration schedules for the instruments and timely completion of same.  Ensuring qualification of working standards and procuring the reference standard , impurity standards and other laboratory required items.  Investigation of OOS/OOT/OOC occurred in the quality control laboratory.  Responsible for Laboratory Incident investigation.  Responsible for supporting in market complaint investigations  Responsible for maintaining and continuous improvement on 21 CFR part 11 compliance.  Coordinating with Production, SCM, QA, warehouse for timely dispatches.  Coordination with the external testing laboratories for analysis.  Ensuring that all documentation work is completed on time.  Ensuring a safe environment is maintained in the laboratory.  Regularly provide the training to the colleagues.

Qualification & ExperienceMore than 5 year experience in QMS like handing of change control, deviation, OOS and Audit properness and Audit facing knowledge of electronic system like Track wise, SAPEssential Qualification MSc Chemistry/ BTech Chemical

Responsibilities Responsible for design the scheme of experiments for given target with scalable, safe, environment friendly and cost effective process.  Responsible for technology accommodation, DOE, demonstration and active participation in successful technology transfer.  Plant trouble shooting, investigation and root cause analysis support.  Guide in carrying experiments during the feasibility and optimization stage.  Visualize the development needs of the product in advance.  Guiding in preparation of RFP and coordinate with all CFT.  Understand the safety and environmental aspect.  Solve the problems and queries related to the development of the product.  Identify all critical process parameters for a seamless scale-up.  Guide in carrying IUT, VQ, TL, LFR/PDR reports documentation individually/review.  Understand the scalability of the chosen process, in coordination with TSD and Production.  Amicable relationship with all cross functional teams.  Keep the HOD well informed about the experiments and the results by maintaining the lab journal/ documents as well as per GMP requirements.  Document all the relevant data in systematic manner and regularly discuss with HOD for way forward.  Good knowledge on literature search resulting on best ROS and process.  Mentor, empower and guide the scientists and junior chemists in the lab on process development, GMP and good communication.  Responsible for the team training needs and appraisal along with the HOD.  Keep the work area clean, safe and the laboratory auditable all the time.  Responsible for department related administrative activities identified by self and HOD from time to time.

ResponsibilitiesEnsure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products. Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality procedures. Perform impact and risk assessments for critical quality events. Assess and categorize deviations and determine the impact on affected batches. Coordinate with Teva affiliates regarding deviations that may affect product deliveries. Review and evaluate deviation reports from contract manufacturers, assessing their potential impact on the batch release process in collaboration with the responsible Teva release QP. Participate in regulatory inspections, Teva corporate inspections, and internal self-inspections within the scope of responsibility. Collect and analyse quality data and documentation, prepare documentation packages for Quality Alignment Meetings (QAMs) and Market Action Committees (MACs) in accordance with approved templates, and prepare Health Authority (HA) notification letters. Monitor and trend deviations and quality metrics to identify improvement opportunities. Prepare and report KPIs related to quality events and deviation management. Author and maintain local SOPs related to critical quality issues, deviation management, CAPA, and CAPA effectiveness.Qualification & ExperienceExperience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance Master’s degree in pharmacy, chemistry, similar natural sciences, engineering or at least several years working experience in the quality assurance area Understanding of the drug manufacturing process. Knowledge of generics and branded product development is a plus

ResponsibilitiesTo Manage the QC Chemical laboratory operations including wet chemistry, instrumental analysis (HPLC, GC, UV, IR, etc.), and stability studies. Ensure efficient resource utilization and timely release of test results as per business requirements. Ensure all QC chemical activities are performed in compliance with cGMP, GLP, and data integrity standards. Review and approve test procedures, specifications, analytical methods, and associated documentation. Lead the investigation of OOS, OOT, deviations, and implement effective CAPAs. Ensure proper maintenance, qualification, and calibration of analytical instruments. Oversee the lifecycle management of equipment including procurement, validation, and decommissioning. Lead and mentor a team of QC Chemists and Analysts, ensuring continuous development and training. Conduct periodic performance reviews and skill-gap analysis to strengthen team capabilities Ensure the QC Chemical lab is always in a state of readiness for regulatory and customer audits. Represent the QC Chemical function during audits and ensure timely closure of observations related to chemical testing. Support technology transfers, method validations, cleaning validations, and new product introductions from the chemical testing perspective. Coordinate with QA, RA, Production, and other functions for seamless quality operations. Additional Responsibilities Lead and oversee all Quality Control (QC) activities for API manufacturing. Act as QC Lead, providing strategic direction and technical leadership to the QC team. Ensure compliance with cGMP, regulatory guidelines, and data integrity requirements. Review and approve analytical results, OOS/OOT investigations, and CAPAs. Manage QC documentation, SOPs, validation, and change control activities. Coordinate with QA, Production, Engineering, and Regulatory teams.Qualification & ExpeirenceBachelors Degree B. Pharma - Required Master Degree M. Sc - Required Experience 15 years or more in 15 - 20 Years