ResponsibilitiesAdminister stroke-specific scales to trial participants (mRS and EQ-5D-5L). Review and evaluate assessments conducted by other raters for accuracy and adherence to protocol. Conduct live interactions with raters to provide feedback on scoring techniques and methodology. Participate in training, orientation, and calibration sessions to maintain certification and consistency. Prepare for rater discussions by reviewing case data and relevant documentation. Complete scheduled rater interactions and submit all required documentation promptly. Assist with mock interviews and functional assessments of rater performance as needed. Qualification & Experience  Minimum: Master’s degree (MA/MS) in Medicine, Neurology, Psychology, or related field. Preferred: MD, DO, or PhD. Experience: At least 1 year of clinical experience with stroke patients.Prior experience administering stroke-related rating scales in clinical trials. Proficiency in mRS and/or EQ-5D-5L.Strong interpersonal and communication skills for professional interaction with raters and trial staff. Excellent organizational skills, attention to detail, and time management. Fluent Odia language skills

Qualification & Experience       Qualifications for CasualtyMedical Officer: · PG/ Fellowship inEmergency MedicineMBBS with experience inEmergency Medicine.

Qualification & Experience       Qualifications for Resident Medical Officer:MBBS freshers MBBS with2-3 years of experiencewill be given preference.

ResponsibilitiesShop floor activities: Conduct in-process checks (IPQC) and proof checking during manufacturing and packing operations. Carry out pack line inspection and sampling of bulk finished and finished products. Perform sampling and execution support for process validation and cleaning validation activities. Ensure status labeling of materials, equipment, and areas is maintained as per SOP. Monitor shop floor activities through routine QA rounds and identify/report any discrepancies or non-compliance. Verify dispensing activities to ensure compliance with BMR/BPR. Review environmental conditions (temperature, humidity, differential pressure) during operations. Ensure GDP (Good Documentation Practices) compliance on the shop floor. Issue, review, and reconcile Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). Perform real-time documentation review to avoid errors and ensure right-first-time execution. Review audit trails of production equipment/instruments (where applicable). Ensure completeness and compliance of batch release documentation and support archival of records. Identify, report, and initiate deviations observed during shop floor activities. Support investigation and CAPA implementation related to shop floor eventsQualification & ExperienceB. Pharm / M. Pharm With relevant experience in pharma quality assurance Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA. Familiarity with Liquid Oral dosage forms and/or potent formulations, Sterile, Nasals, OSD (optional)

ResponsibilitiesManufacturing deviations (granulation, compression, coating, packing) Engineering incidents (equipment breakdown, utility failure, HVAC issues) typical events and process interruptionsEnsure investigations comply with cGMP and regulatory expectations (US FDA/MHRA) Qualification & ExperienceMust-Have Skills: B Pharmacy/ M. Pharmacy Must have knowledge on handling manufacturing and engineering investigations. Good analytical and problem-solving skills

ResponsibilitiesEquipment (manufacturing and packing machines) Utility systems (HVAC, Purified Water, Compressed Air, BMS)Ensure engineering activities comply with cGMP and internal SOPsReview and approve engineering-related documents Qualification & Validation (CSV/Equipment/Utilities)Qualification & ExperienceB. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma. Must have knowledge of working on the engineering shop floor as an in-process quality assurance.

ResponsibilitiesQC Analyst Operating HPLC. Conducted tests Assay and Dissolution, CU & BU, Swab Analysis by HPLC. Should be working in Finished Department, having thorough practical experience of FP, PV, HT, CTC specification of all products.Qualification & ExperienceExperience : 2 to 7 years

ResponsibilitiesEnsure online documentation of batch manufacturing and batch packing record. Carryout in-process checks of pre-determined process parameters as per BMR/BPR. Withdraw in-process/FP/Reference & stability samples as per SOP. Monitor environmental condition of critical areas. Review & approve QA SOPs. Ensure the batch release procedure & To review BMR/BPR/QC & Micro data. Handles Aseptic Areas. Participates and execute process validation as per protocol. Ensure and verify online recording for daily log card in warehouse, Mfg., Filling and packing area. Qualification & ExperienceQualification : B.Sc., M.Sc., B.Pharm / M.Pharm Experience : 1 to 7 years

ResponsibilitiesExperience on Daily monitoring and control of environmental condition of F&D area Daily review and knowledge of verification and calibration of all equipment. Internal CCP, correspondence of all TTD related activity and compilation of all documents. Correspondence of IRA dossier related activity like review of PDR, MFR etc. IRA related EB batches BMR, PVP/PVR documents preparation and review. Internal SOP preparation, review and checking and implementation of the same. Documentation and Maintain all F&D related documents like Project File, Registers, Log Book, Status Excel Sheet updating.Qualification & ExperienceExperience: 3 to 5 years

 Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.Qualification & ExperienceBachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. Should have minimum 2-4 years of ICSR case processing experience. Spontaneous / CT & Literature cases Post marketing CP experience is Mandatory