ResponsibilitiesLiterature Management Process Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether full text article needs to be ordered and order them if further information is needed to confirm if citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local Safety Officer to provide English translation if the article is not in English Notify business partner of articles received, if applicable Support audits and inspections Knowledge And Skills Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection Ability to order full text articles where needed Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance Ability to effectively manage competing priorities and timelines Strong knowledge of literature citation management systems and platform used to configure search strategies Experience in use of AI and prompts would be usefulQualification & ExperienceMaster’s degree and 1 year of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR Bachelor’s degree and 1- 2 years of Literature screening/Review or relevant Safety experience

ResponsibilitiesLead and develop team of 7 Senior Associates across Clinical Customer Service, Logistics Vendor Management and Development Supply Chain Technologies. Define goals, manage performance, and support career development. Ensure appropriate staffing, cross-training, and succession planning. Foster a culture of accountability, compliance, and customer focus Drive adoption of new technologies and AI to increase team productivity and enhance performance Clinical Supply Chain Execution OversightEnsure efficient and compliant execution of assigned clinical supply chain processes with patient-centric mindset Closely coordinate issue triage and workload prioritization with global peers Monitor KPIs and overall team performance and drive corrective actions and learning when needed Provide guidance on complex operational matters. Ensure adherence to GMP, GDP, and regulatory requirements.Performance & Process ManagementEnsure procedures are current, compliant and inspection-ready Drive root cause analysis and continuous improvement. Represent the team during audits and inspections.Cross-Functional & Global CollaborationPartner with Global Clinical Supply Chain, Clinical Study Teams, Quality, Finance, and DTI. Translate global priorities into actionable local plans.Qualification & ExperienceBachelor’s Degree and 8+ years of supply chain, logistics, planning, or operations experience

ResponsibilitiesAuthor or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)  Provide functional area input for Global Regulatory Plan and team goals  oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned  lead departmental and cross-departmental initiatives, as appropriate Generate document timeline and keep abreast of relevant professional information and technologyQualification & ExperienceDoctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience

ResponsibilitiesLead end-to-end supplier quality processes such as Vendor Change Notifications (VCNs), Supplier Quality Agreements (QAAs), and supplier complaints to ensure timely and compliant handling Evaluate supplier changes and requests using risk-based and analytical decision-making to protect product quality and supply continuity Review and approve supply chain records (VSCI) governing the use of materials, services, and equipment across the Lonza network Collaborate with cross-functional teams (Manufacturing, QC, Procurement, MSAT, Planning) to assess impact and manage risks effectively Maintain accurate supplier documentation, ensuring compliance with quality management systems, regulatory requirements, and data integrity standards Monitor and report key performance indicators (KPIs) related to supplier quality processes, identifying risks and driving continuous improvement Act as a global point of contact for supplier quality topics, supporting audits, inspections, and alignment across internal and external stakeholders

ResponsibilitiesMajor Tasks Job Description Summary Presents pharmaceutical products to prescribing healthcare professionals, including generalist practitioners, specialists and hospital professionals. Delivers therapeutic information in compliancewith ethical rules and according to the marketing and sales strategies defined for the product line. May use various e-detailing platforms such as web-based or video conferencing/training, data specific web sites, physician portals and blogs.

Responsibilities Stability Program Ownership Approve stability protocols — long-term, accelerated, intermediate, in-use, and photo-stability — per ICH Q1A(R2), Q1B, and Q1E. Own stability schedule across all marketed products and ongoing commitments. Approve product stability reports for regulatory submissions per ICH Q1E. Approve annual stability protocols for marketed products and ongoing commitments.  Compliance & Investigations Approve all stability OOS / OOT investigations (Phase 1, 2, 3) and CAPAs in QMS. Be a key audit-facing person for Stability during regulatory and customer audits. Drive ALCOA+ and data integrity compliance — audit-trail review, individual logins, paper-on-glass elimination.  Chamber & Inventory Management Drive temperature mapping of stability chambers (initial qualification + yearly re-mapping; hot / cold spot identification). Coordinate chamber alarm and excursion response — chamber recovery, sample impact assessment. Maintain stability sample inventory dashboards — due-date tracking, OOS / OOT count.  People & Cross-Functional Coordination Manage 3 – 5 across Senior Executive, Junior Executive, and Trainee levels. Mentor junior executives and trainees on stability HPLC and classical analysis. Coordinate with QA Stability, F&D / ADL / RA on protocols, climatic zone strategy, and submissions.Qualification & ExperienceB.Pharm / M.Pharm Experience 8 – 12 years; multi-section / department-coordination level (OSD experience preferred).

ResponsibilitiesPerform sampling of raw materials (RM), packaging materials (PM), and water systems as per approved sampling procedures. Conduct analysis of RM and PM as per specifications, including identification, physical, and chemical tests applicable to materials. Perform routine water analysis (e.g., purified water, potable water) as per defined specifications and standard test methods. Execute tests such as identification (FTIR/UV/chemical), loss on drying, pH, conductivity, and other applicable tests specific to RM/PM/Water. Ensure proper labeling, handling, and storage of RM/PM/Water samples during sampling and analysis. Maintain accurate raw data, analytical records, and worksheets related strictly to RM/PM/Water activities. Ensure timely completion of sampling and analysis to support material approval and production requirements. Follow approved SOPs, STPs, and specifications applicable to RM/PM/Water without deviation. Ensure adherence to data integrity principles (ALCOA+) in all RM/PM/Water-related activities. Identify and report OOS (Out of Specification) and OOT (Out of Trend) results observed during RM/PM/Water analysis. Maintain cleanliness, safety, and discipline in sampling and laboratory areas related to RM/PM/Water. Qualification & ExperienceQualifications: B.Sc. / Msc. / B.Pharm Experience: 0–2 years of experience in a pharmaceutical company (OSD preferred).

Responsibilities Stability Sample Management Manage stability sample withdrawal, storage, and handling as per approved stability protocols and ICH Q1A(R2). Perform sampling of stability batches at defined time-points — initial, intermediate, accelerated, long-term, photo-stability, in-use, and stress studies. Ensure proper labelling, storage conditions, and segregation of stability samples in designated stability chambers. Stability Testing Conduct analysis of stability samples as per approved specifications and test procedures. Execute tests including Assay, Related Substances (HPLC), Dissolution profile, Content Uniformity, and physical parameters (description, hardness, friability, DT, water content) as applicable to stability study requirements. Ensure timely completion of stability testing and reporting as per stability protocol timelines. Document results in stability protocols, summary sheets, and reports. Chamber Monitoring & Trending Monitor and record stability chamber conditions (temperature, relative humidity) as per defined frequency. Maintain stability chambers — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH. Respond to chamber excursions per SOP. Participate in trending and interpretation of stability data. Ensure timely review and notification for any trending abnormalities or failures. Analytical Instruments to be Handled Stability Chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH) HPLC, UV-Vis Spectrophotometer Dissolution Apparatus, Disintegration Tester Hardness & Friability Testers, KF auto-titrator pH meter, Analytical balances Documentation & Compliance Follow ALCOA+ principles for data integrity. Adhere to cGMP, GLP, ICH Q1A / Q1B / Q1E, and Schedule M norms. Maintain stability raw data, worksheets, and analytical records. Participate in internal audits, regulatory inspections, and CAPA closure. Ensure calibration and preventive maintenance of stability chambers and analytical instruments is up to date.Qualification & ExperienceQualification B.Sc / M.Sc / B.Pharm Experience 1 – 3 years (OSD experience preferred).

ResponsibilitiesResponsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements.Qualification & ExperienceQualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance.

Qualification & Experience      Critical Care - Medical Services5+ years post PGMD/DNB (Medicine/Pulmonary Medicine/Anaesthesia) + IDCCM/FNB