ResponsibilitiesPerform various tests and analyses related to Hematology in a laboratory setting. Support the Clinical Development team with scientific expertise for oncology and hematology projects. Provide application support for Hematology products and assist with biochemistry roles. Qualification & ExperienceBachelor's degree in a related field. 4-5 years of experience in Hematology or a similar role. Strong knowledge and experience in Hematology testing and analysis. Excellent communication skills and ability to work in a team. Ability to provide scientific support to cross-functional teams.

Responsibilites Domestic 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

ResponsibilitiesTo ensure the timely execution & oversee success of all pragram intervention at site. To align central leads on daily plan for each interventions. To oversee the success of quality circle work stream at site. Monitor the status of continuous improvement initiatives. Monitor the success of gemba walk at site. To conduct quiz collect the data & resolving bottleneck issue.Qualification & ExperienceB.Pharmacy Relevant skills / Industry experience Experience in QMS, Regulatory exposure& data analytics. USFDA exposure is must. Minimum 10 years experience required.

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.Qualification & ExperienceB. Pharm/ M. Pharm/ MSC. Relevant skills / Industry experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

ResponsibilitiesEnsure compliance of global ICSR distribution by correct distribution rule set-up in the Safety Database. This includes : Regular monitoring of regulatory information system.Regular review of distribution requirements received from ASRsPerform plausibility checks and impact analysis of changes in regulations and ensure implementation of distribution rules in Safety DatabaseContact person for ASRs for redistribution of cases, updates of distribution rules, contacts, products, timelines and local requirements in the Safety databaseContact person for ICSR reporting requirements for other GPV groups, e.g. Case Processing, QPPV, Compliance, Safety Database OperationsAct as deputy ICSR Distribution CoordinatorPerform regulatory reporting to EMAMonitor Global Safety database Submission section for received/failed acknowledgementsQualification & ExperienceMaster in Science, Ph.D. in Life Sciences, B.E. or B.Tech or equivalent Excellent

ResponsibilitiesProvide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals. Develop the international regulatory strategy and contribute to Global regulatory plans. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support and advise on the local label strategy and alignment to cCDS/reference label. Build effective relationships and communication paths across global, regional, local and functional organizations. Enable efficiencies and seamless execution across the international countries. Contribute to process improvement projects, as assigned.Qualification & ExperienceDoctorate degree and 6 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience

Responsibilities Lead end-to-end technology transfer of formulations (OSD / semi-solids as applicable).  Plan, review, and approve Technology Transfer Protocols (TTP), Reports (TTR), and risk assessments.  Coordinate transfers from R&D, pilot plant, contract manufacturers, or global sites.  Ensure readiness of manufacturing processes, equipment, and documentation. Process Scale-Up & Validation  Lead scale-up, exhibit, and PPQ batches.  Define and monitor CPPs, CQAs, and control strategies.  Support and review process validation, cleaning validation, and hold time studies.  Drive process optimization and yield improvement initiatives. Cross-Functional Coordination  Act as a technical interface between R&D, Production, QA, QC, Engineering, Supply Chain, and Regulatory Affairs.  Provide technical inputs for regulatory filings, queries, and variations.  Support new product introduction (NPI) and site transfer projects.Qualification & ExperienceEducation: B. Pharm / M. Pharm

Responsibilities Timely testing with online documentation of various sample stages including in-process, intermediate, drug substance/ drug product, stability samples of Biotherapeutics proteins for test parameters including but not limited to HPLC methods, Host cell DNA contaminants quantification by RT PCR, Host cell protein contaminants quantification by ELISA, Electrophoresis, ELISA based assays and general procedures including but not limited to extractable volume, sub-visible particle testing, pH, conductivity. Should work in shifts. Preparation of reagents/ solutions required for routine testing and maintenance of their records.  Preparation and periodic updation of SOPs, STPs and Specifications pertaining to testing of Biotherapeutics.  Perform In-house calibration/ verification of Analytical equipment as per the approved procedures and calibration/ verification frequency. Online monitoring and maintenance of equipment records.  To ensure cGMP compliance and maintain the laboratory in audit ready condition. To report any Deviations/ Out of Specifications results and Safety risks to the supervisor as and when observed.  Participation in transfer of analytical methods from R&D to QC.  To attend all GMP/ On-job/ additional trainings as per the approved training matrix and update the training records. 

Qualification & ExperienceDNB/MD Radiologist with 0-5 years of experience to join our healthcare team.

ResponsibilitiesAssess the identity, strength and purity of medications. Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage. Analyze prescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions. Order and purchase pharmaceutical supplies, medical supplies, and drugs, maintaining stock and storing and handling it properly. Maintain records, such as pharmacy files, patient profiles, charge system files, inventories, control records for radioactive nuclei, and registries of poisons, narcotics, and controlled drugs. Advise customers on the selection of medication brands, medical equipment and health-care supplies. Collaborate with other health care professionals to plan, monitor, review, and evaluate the quality and effectiveness of drugs and drug regimens, providing advice on drug applications and characteristics. Compound and dispense medications as prescribed by doctors and dentists, by calculating, weighing, measuring, and mixing ingredients, or oversee these activities. Offer health promotion and prevention activities, for example, training people to use devices such as blood pressure or diabetes monitors. Prepare sterile solutions and infusions for use in surgical procedures, emergency rooms, or patients' homes. Plan, implement, and maintain procedures for mixing, packaging, and labeling pharmaceuticals, according to policy and legal requirements, to ensure quality, security, and proper disposal. Teach pharmacy students serving as interns in preparation for their graduation or licensure. Publish educational information for other pharmacists, doctors, and/or patients.