Responsibilities• Implementation of hospital's /medical services vision & philosophy.• Infection control, Health care waste management, awareness of patients rights & safety issues, relationship building.• Supplement/take charge in case the vertical is on leave/absent etc.• Strategic inputs in her/his vertical & should forward recommendation for continuous improvement in the vertical.• To prepare Discharge summaries for all assigned patients. Discharge summary shall be prepared and updated atleast a day prior to expected discharge date. Discharge Summary must be complete in all aspects with accurate diagnosis details, hospital course, procedures carried out, significant tests, medications prescribed and follow up appointments. Once the discharge is confirmed by consultant, ensure that the updated discharge summary is approved and signed by the consultant in eHIS.• To provide the best possible prompt medical care to all patients in the specialty.• To work out all admitted patients in Day care & Ward, to take detailed history.• Check Chemotherapy prescription orders, verify and also check actual drug dosages & method by which it is given.• Supervise chemotherapy administration.• Networking with other Deptt. for any procedures, surgery, cross consultations.• To prepare Discharge summaries.• Discussion with patients regarding chemotherapy related issues.• To assist / perform Bone marrow procedure, lumber puncture.• To enter Patient related details in HIS like day to day notes, patient history, discharge notification etc.• To fill proformas, estimates for TPA’s etc, to keep a second copy of all the forms sent for such purpose in the Patient record file.• To ensure no drug wastage esp. during Chemotherapy.• To ensure waste management of all cytotoxic & biomedical waste as per state pollution control board.• To write progress notes of the patients in the records at least twice in one shift. The notes should be relevant to the patient current health status & treatment should reflect the future plan in compliance with the admitting consultant.• To liaise with the admitting consultants & to start the follow up treatments.• To coordinate all the references with other specialists if desired.• To ensure all the investigations are sent & the reports are interpreted & inform the concerned consultants. To ensure all related follow up including any change in the line of treatment on the basis of the reports of the investigations.• To give bedside over to the reliever while going off duty.• To ensure the diets of the patients are ordered as per the recommendations.• To ensure that the medicines to the patients are delivered as per the prescriptions.• To counsel all the discharged patients for further follow ups & to handover the discharge summary. The second copy of the same should be countersigned by the patient or the attendants & to be kept in the patient record file.• To take round with all the Consultants, Classified Specialists, Gr. Specialists in the specialty & to document the instructions & to ensure their compliance.• Collective rounds with the verticals, subordinates & to ensure all preventive & corrective measures to maintain the highest standards of patient care & service delivery.• Should facilitate all audits in the concerned areas & answer all their queries.• Inventory management, In addition to that to ensure systems to avoid wastages/pilferages/thefts etc.• To ensure SOP’s of the Medical Services be implemented.Qualification & Experience  • Education A recognized degree from Medical Council of India. Must be registered with State/Medical Council of India.• Experience 0- 1 year of relevant experience in the concerned specialty in a Super/Multi Specialty hospital is preferable.

ResponsibilitiesReview of Product Quality Complaint Investigation Reports (Drug Products). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports (FAR), Recalls & Product Quality Complaint closure etc. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received Product Quality Complaints.Qualifiication & ExperienceB.Pharma / M.Sc (Life Sciences) Experience 13 to 15 Years

ResponsibilitiesEducating patients along with family members and making them understand the process/procedures/issues related to pre and post – transplantAdministration of Liver Transplant ProgramEnsuring documentation, including informing about consent of potential organ donor and transplant recipientDeveloping internal and external resources that are appropriate for patient education in all phases of transplantation careAnalysing medical data of potential organ donors and transplant recipients for medical and social recordsFacilitating consultation with the help of case presentation with team members to screen potential recipients and donorsAssisting the transplant physician to compare and analyse collected data to normal values and correlating and summarizing laboratory reports, x-rays and other tests to assist physician to determine medical suitability of procedureCoordinating evaluation process for pre-transplant (referral) patientsAssisting hospital staff and nurses to evaluate, plan and implement proper care of recipientAdministrating transplantation process when a deceased donor is available including communication between the physicians, ZTCC, patient/families, liver team, blood bank, Cardiac OTFacilitating for in-hospital services, counselling of recipient and donor to alleviate anxieties and assist recipient and donor throughout procedureAdvising post-operative patients for managing post-transplant care and follow-upCompleting necessary documents according to DHS guidelines including listing, status changes and post-transplant follow up informationMaintaining patient’s recordWorking collaboratively with administrators, accounts executives, MSW & TPAParticipating in conference, meetings and awareness programs for organ donationRegistration of new patients in ZTCC waiting list for deceased donor liver transplant & maintaining their record. Refund them if they do not opt for cadaver transplantFilling social history for new adult and pediatric casesMonthly DHS, ROTTO, SOTTO and NOTTO reportingArranging, co-coordinating weekly Wednesday meetingsAs a part of day-to-day tasks, answering phones, schedule appointments, filling patient records & coordinating in issuing and paying billsICU and CCU records for identification of brain-dead cases and no. of liver disease cases for statisticsProcess transplant forms, prepare reports and assist physicians with various presentation or articlesAct as liaisons between the KEM Authorization Committee for transplants, medical staff and departmentsTo arrange Authorization Committee meetings for permission for transplantsPresenting all the necessary documentation to the committeeTo coordinate the donor and recipient’s family members meeting with the authorization committeePlanning budgetsRaising funds for needy patientsInforming the transplant team about the patients admitted of liver diseases in our hospitalActing as the nodal person for the Liver Transplant team for liver patients admitted in the hospital and informing the teamAny other work/responsibility assigned by the HOD/Management in the course of business/work whether within the same unit/dept or any other unit/dept from time to timeQualification & Experience  QUALIFICATION: Graduate in a recognized system of medicine / Qualified Nurse / Bachelor’s degree in any subject and preferably Master’s Degree in Social Work or Psychiatry or Sociology or Social Science or Public HealthEXPERIENCE: 1 – 2 years Hospital experience preferred

ResponsibilitiesEnsure hardware qualification of computerized systems is completed as per approved protocols. Prepare, review, and execute qualification and validation documents for computerized systems and laboratory instruments. Perform and review software validation for new instruments in line with 21 CFR Part 11 requirements. Implement system and software validation for newly installed instruments/software. 2. Regulatory Compliance – 21 CFR Part 11 Maintain and secure 21 CFR Part 11 compliance of laboratory instruments and equipment. Ensure compliance related to ERES, audit trails, software categorization, user and role management, and data security. Act as administrative rights holder for instrument and equipment software installed at SPML Baska. 3. System Administration & IT Support Preparation, review, and approval of System Administrator procedures for QC instrument software. Perform IT?related activities as defined in instrument/equipment SOPs. Execute DTC?related activities for the IT department. Monitor EDMS form due dates and system documentation lifecycle. 4. SOPs, Documentation & QMS Review, prepare, and maintain SOPs related to: Backup of electronic data System control policies IT infrastructure and system security Preparation, review, and approval of IT?related protocols, policies, and documentation. Preparation, review, and approval of QMS documents as per internal procedures. Maintenance of Computerized System (CS) Software Inventory.Qualifiication & ExperienceBachelor’s degree in Computer Science, Information Technology, Engineering, Pharmacy, or Science Specific CertificationExperience 3-5 years of relevant experience in: IT support for pharmaceutical or regulated environments Computerized System Validation (CSV) Laboratory systems and instrument software

ResponsibilitiesEvaluate current systems and processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and Global Quality Systems/ SOPs (GQSs/ GSOPs) in collaboration with relevant stakeholders in R&D. Conduct the outsourced BA/BE study audits (both healthy volunteer and patient based) which include investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), In-process audits etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines. Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) Qualification/ Re-qualification audits. Verify adequacy of all created & executed CAPAs, including CAPA identified as a result of audit by corporate audit department, followed by adequacy and effectiveness check of implemented CAPAs. Harmonize the QA systems and processes, wherever applicable and feasible, across the organization for in-house and outsourced BA/BE Studies.Qualifiication & ExperienceMinimum graduate / post graduate degree in basic sciences Experience Tenure: At least 14 years of experience in GCP environment of which at least 06 years’ experience must be in Quality Assurance (QA).

ResponsibilitiesIssuance, archival and retrieval of documents. Issuance of Control coples to respective dept. Destruction of the GMP documents once the retention term has passed and controlled coples of the obsolete GMP documents. Tracking of all QA documents. 5. Maintaining backup of QA softcoples. Maintaining SOP/s with proper indexing. Preparation and review of SOPs Management of QA Stationary (Controlled Coples and logbooks) Dispatch and line clearance activity. Review of BMR/BECR Perform Qualification for new Equipments/Existing Equipments Ensure & Co-ordination of area validations. Reviewing of calibration /PM Schedules. Preparation of VMP &validation Documents Handling of Vendor Qualification Activities. Any other work assigned by HOD/Second line.

ResponsibilitiesLead and execute process validation activities, including protocol generation, execution, and report writing for new and existing products. Provide technical expertise and troubleshooting support for manufacturing operations, resolving deviations, and implementing corrective and preventive actions (CAPAs). Participate in technology transfer activities for new products and processes from R&D to commercial manufacturing. Conduct process optimization studies to improve yields, reduce cycle times, and enhance product quality. Collaborate with cross-functional teams including Production, Quality Assurance, Quality Control, and R&D to ensure seamless execution of projects. Prepare and review technical documents, including batch records, specifications, and standard operating procedures (SOPs). Support regulatory submissions by providing necessary technical data and documentation. Stay updated with industry best practices, regulatory guidelines (e.g., cGMP, ICH), and new technologies in pharmaceutical manufacturing. Participate in investigations of critical quality events, out-of-specification (OOS) results, and customer complaints.Qualification & ExperienceBachelor's degree in Chemical Engineering. 5-8 years of experience in a Technical Services, Process Development, or Manufacturing role within the pharmaceutical industry. Strong understanding of pharmaceutical manufacturing processes (e.g., solid oral dosage forms, sterile injectables, APIs). Proficient in process validation, technology transfer, and process optimization principles. Familiarity with cGMP, ICH guidelines, and other relevant regulatory requirements.

ResponsibilitiesPreparation of protocol for validation/qualification pertaining to Process, Cleaning, Equipment and area/HVAC Execution of validation/qualification activities Coordination with different departments for performing validation/qualification activities Compilation of data and report preparation Maintaining documents as per Document control policy Lessoning with FDA for manufacturing licenses and certificates.

ResponsibilitiesResponsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale Gap analysis - To evaluate the product feasibility, technology feasibility at manufacturing site along with gap analysis with available technology for site readiness Documentation – Onsite documentation, and timely execution of scaleup, exhibit and validation batches Risk assessment – To carry out the risk assessment to identify the impact of critical process parameters and critical material attributes To design and review the sampling plan for scaleup, process optimization and submission batches To study and verify the parameters established during development are still with in the determined design space in scaleup and exhibit batches To coordinate with other departments at plant in completing scaleup and exhibit batch related activities In coordination with CMO and PM, ensure the availability of raw materials, packaging materials, filters, tubings etc. required for scale-up, exhibit and commercial batches before initiation of execution Compile the batch orsevations and prepare the report of scale-up, EB and commercial/PV batches To ensure smooth technology transfer of products developed at Apotex to CMO Technical support to formulation development team Involve in formulation development activities and assist in development of scaleable manufacturing process Review and compilation of the developmental plant scale batches data and stability results Coordination with different cross-functional teams like AD, procurement, QA, packing, regulatory affairs, project management for smooth execution of scale-up batches Coordination with external labs for successful completion and receipt of studies data performed for plant scale batches Review of MFR, BMR, BPR, stability protocols, study protocols and reports, Executed BMR, BPR, Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting Report to next level manager regarding day to day activities. Preparation of SOPs and ensure compliance as per SOP Take up any other work as allottedQualification & ExperienceD /M Pharma in Pharmaceutics/B.Pharma. Knowledge, Skills and Abilities Must have experience in development and tech-transfer of injectable and ophthalmic and complex drug products Effective command over verbal and written communication with good interpersonnel skills. Engage with CMO partners and support the group submission plans Proficient in MS office and advanced software tools. Having well versed knowledge on regulatory guidelines Able to priortise the task, best in effective planning of work activities to meet the timelines. Experience Minimum 6 to 10+ years of experience in Injectable and Ophthalmic dosage forms in area of Development, Manufacturing and technology transfer expertise for CMO.

ResponsibilitiesDesigns, prepares, and reviews stability protocols for R&D QA pre-approval. Evaluates analytical methods to determine suitable quantities of product for stability studies based on the corresponding testing plan. Reviews and evaluates stability data for the ongoing stability studies to ensure that significant trends that warrant attention are evaluated. Notify Manager of any concerning trends detected. Prepares, reviews, and publishes Stability Summary Reports, Executive reports, Shelf-life extension reports, Statistical evaluation reports, etc. within compliance time frame. Prepares and provides stability summary reports, including trend analysis and product evaluations for internal or external customers. Performs review of stability summary data provided by third party affiliates (e.g., contract laboratories) for completeness and compliance. Provides day to day technical support, direction, and guidance to the R&D Stability team members, including problem solving and troubleshooting of stability program related issues, and suggests remedial and corrective actions, when required. Acts as an area SME on TrackWise - Deviation and CAPA management system. Proficient in creating and verifying stability protocols in LIMS, and initiating stability studies. Prepares and oversees the execution of the monthly stability pull schedule, and assists with the preparation of different stability status reports, including the monthly reports. Involved in the creation and management of departmental change controls within the QMS Trackwise system. Liaises with LIMS Operations, Formulations Development and colleagues in Analytical R&D to ensure that all information required for stability protocol is complete. Provides information regarding the R&D stability studies to Formulation Development, Global Regulatory Affairs and other internal/external customers. Performs specification updates to all active stability studies within Labware LIMS when a change control for stability test profile is completed. Logs all Environmentally Control Chamber alarms from Building Systems and performs quarterly alarms reconciliation. Works with Manger, R&D Stability to improve departmental processes and SOP’s. Provides weekly status updates to the Manger, R&D Stability. Shares knowledge with team members and across R&D. Provides cross training and support to new team members. Monitors training progress and ensures all training gaps are completed within MyHR for Documents, GMP, Safety, Technical and Software courses. Works as a member of the team to achieve all desired quality/compliance outcomes. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned, including back-up for coordinator role.Qualification & ExperienceA graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university. Knowledge, Skills and Abilities Strong working and theoretical knowledge of ICH Guidelines as it pertains to NPD Regulatory submissions. Thorough understanding of GMP and GLP guidelines and related SOPs and their application in a laboratory setting.6+ year experience in pharmaceutical industry, preferably including experience in project management and coordination of work assignments.