Qualification & ExperienceDepartment : Pharmacy                              Qualification : Graduate/ Pharmacy knowledge      Experience : 1+ Years Location : Raiganj       

ResponsibilitiesManagement of patient care. Supervise, guide and help the nurses to provide high quality nursing care from admission to discharge of the patient. Audit of the nurses in their clinical practice to ensure that they are working the way they are trained. Responsible for Clinical Audit to ensure clinical processes, protocols are followed in proper manner. Responsible for Monthly Nursing Audit to ensure the effective and efficient patient care. Responsible for preparation of Monthly Key Performance Indicators Report. Do the regular round of the patient to ensure that the patient is comfortable. Attendance and assignment of personnel (Duty Roster Management). Ensure that the inventory of equipment is done, placed in proper place in working condition. Ensure that the emergency trolley is up-to-date and everything is available and in working condition. Ensure proper nursing documentation in the patient’s file from admission to discharge. Indent and maintenance of ward stock of drugs, disposables, consumables and other required items. Ensure that records like admission, discharge, birth, death census, MLC cases etc. are properly maintained. Management of emergencies like cardiac arrest, hemorrhage, post operative complications etc. Ensure patient safety. Ensure that the infection control guidelines are strictly followed by all staff. Ensure patient satisfaction regarding clinical care. Supervise the staff nurses, guide them and help them as and when required Waste management is done as per policy. Ensure that all the queries are properly addressed and corrective and preventive action report is generated for those queries. Responsible for the welfare of staffs in the department Responsible for periodical the performance appraisal of the staffs in the department. Recruitment, placement and orientation of the newly joined staff. Coordinate staff meetings to get suggestions for implementing improvements. Implementing standing orders and protocols. Responsible for training initiatives within the hospital related to nursing care and infection related practices.Qualification & ExperienceQUALIFICATION : GNM/ Bsc NURSING EXPERIENCE : 8-10 YEARS IN HEALTHCARE 

Responsibilities Write and prepare standalone post-marketing aggregate safety reports, such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs) and associated reports, for regulatory submission; perform quality control reviews of aggregate safety reports. Ensure all assigned aggregate safety reports are processed and submitted according to regulatory requirements and internal timelines. Assist in the preparation of timely function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities. Collaborate with Drug Safety Physicians, EU-QPPV, and GPS Risk Management Head/Specialist concerning safety issues relative to safety writing activities. Interface with other Baxter functional groups, such as Regulatory Affairs, Clinical/Medical Affairs, Quality, Data Management, or other business units as needed. Support the creation, improvement and maintenance of Medical Safety Writing standardized departmental procedures and processes.Participate on assigned project teams and committees.Qualification & ExperienceBachelor’s or Master’s degree in Pharmacy or Life Sciences (or equivalent scientific discipline). Experience 2 to 6 years of relevant experience in Medical Safety Writing,

ResponsibilitiesResponsible 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  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

Responsibilities Drives adherence to SFE processes, Call average, customer coverage, working days, SME trackers, prescription trackers, 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 accountsQualification & Experinece B Pharma / B.Sc. / B. Tech with master’s in management would be add on.  Experience: 4 Years +

ResponsibilitiesDomestic regulatory filing and approval. Submission of registration dossier/s as per MOH requirements initially in countries, to explore further in different markets as per managements decision. Review/Gap analysis of the existing versus US/EU regulations & dossiers as per ICH guidelines, country specific requirements. Maintain current knowledge of relevant regulations for registrations in International markets. Coordinate with regulatory activities such as international audits & regulatory agency inspections, product recalls. Planning dossier submission timelines in coordination with QA.Qualification & ExperienceM.Pharm ( RA / QA ) Relevant Skills / Industry Experience 10-15 Years in Regulatory/ Compliance Related Activities

Responsibilites  Media fill and qualification summary preparation knowledge.  To maintain track of qualification and validation activities.  To prepare and review the protocols and reports. Execution of various qualification / validation activities.  To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT).  Co-ordinate with production and other user department for qualification/validation activities  Timely compile and review of qualification validation reports.  To review the equipment documents like calibration reports and ensure correctness of documents.  To perform FAT.  To co-ordinate with outside agencies for execution of qualification activity whenever required.  Identification of deviation through review and observation.  To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required. Qualification & ExpeirneceB. Pharm/ M. Pharm/ MSC. Relevant Skills / Industry Experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

Responsibilites Lead a team of analysts and oversee assigned analytical projects. Provide analytical support during scale-up, global development, and technology transfer activities across the product lifecycle. Perform and/or provide training on analytical methods including HPLC, gel/capillary electrophoresis, HCD, and ELISA-based methods, ensuring generation of high-quality data. Prepare and review instrument SOPs, IQ/OQ documents, PV documents, MOAs, and technical reports. Participate in equipment qualification and requalification activities. Perform and support method development and method qualification activities. Ensure availability of required consumables, reagents, and other laboratory resources.Qualification & ExperienceMinimum 6+ years of experience working in an analytical laboratory (QC or R&D) on biosimilar products. Strong scientific knowledge of analytical techniques with an adequate understanding of upstream and downstream processes. Expertise in HPLC (routine operation, troubleshooting, and maintenance) with hands-on experience in RP-HPLC, SE-HPLC, IEX-HPLC, and N-glycan analysis.

Responsibilities Refine literature review questions in alignment with team lead and prepare research protocols. Design literature searches for electronic databases (e.g., PubMed, EMBASE, Cochrane Library) and grey literature (e.g., conference proceedings, regulatory sites). Screen abstracts and full-texts to determine relevance based on PICO criteria. Create and review PRISMA diagrams to document full-text study selection. Extract data from included articles into a predefined data extraction template Draft evidence tables, figures, final reports, and presentation decks, interpreting patterns and trends. Ensure quality of assigned work People: (1) Support and maintain effective relationships with key stakeholders (2) Work effectively with global HEOR teams across various time zonesQualification & ExperineceBachelor’s or Master’s degree in pharmacy, health economics, public health, medicine, epidemiology, or a related health sciences field. Experience Years of relevant experience in systematic literature review methods in the pharmaceutical, biotech or consulting setting: +3 years for Master’s degree and +5 years for Bachelor’s degree. Experience of conducting different types of literature reviews (clinical, economic, QoL, burden of illness etc.)

ResponsibilitiesThe Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.  Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance Due to the global nature of the role, must be willing to work in shift that overlaps with EU and US time zone, if required. What we expect of you We are all different, yet we all use our unique contributions to serve patients.Qualification & ExperienceMaster’s degree and 4 to 7 years of Quality experience OR Bachelor’s degree and 5 to 9 years of Quality experience OR Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry