January 2025

He, she participates in all activities relating to preparation, submission and follow up to obtain approvals, renewals for products and its variations and line extension indications and labeling approvals of medical devices of various business units of Medtronic. He, she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures

Supervision of aseptic area activities, shift handling, aseptic area documentation, media fill activities, aseptic behaviour monitoring, and sterile operations. Handling area cleaning and sanitation activities, supervising steam sterilizer loads, filter integrity, disinfectant preparation and filtration activity, and related documents.

M.Pharm / M. Sc; Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC,UV, IC ,GC,ICP MS and AAS etc. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.

Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.

Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA, Food and Drug Administration and EMA, European Medicines Agency, and SOPs/ QDs. Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF Case Report Form and completion guidelines, Centralized Monitoring Plan, committee charters and or other operational documents as requested to provide operational input.

Diploma in Pharmacy from a recognized University, Institution. Should be a registered Pharmacist under the Pharmacy Act 1948 Desirable Experience in the manufacture, storage, testing of transfusion fluids in a reputed hospital or industry

Pass in D. Pharma, B. Pharma or Intermediate vocational course in Pharmacy recognized by Government of AP  Must be registered with the A.P. Pharmacy Council. In case of candidate possess both D. Pharma and B. Pharma, the maximum percentage secured in any of the above shall be considered.

BDS, BAMS, BHMS, B.Pharm, BSc, Any Degree. Three years experience of working in a 500 Bedded Hospital. Master in Health, Hospital Administration, PG Diploma in Health Hospital Administration.