3-4

1 to 3 Years of experience in Production Department of Pharma Formulation. HOF Pharmaceuticals Ltd are a pharmaceutical formulation manufacturing company that is committed to shine through its quality products and exceptional customer service.

Exposure of Equipment and Utility Qualifications. Good Knowledge of Process Validation, Cleaning Validation. Management of QM5. Exposure of Stability and Artwork Management Analytical QA Handling of OOS, Risk Assessment, Self Inspection, APQR

Knowledge of 21 CFR Part 11, Annexure 11, CSV, GAMP 5, data integrity requirements for Pharma, Computer Software Assurance, IT systems and ITIL processes e.g. backup, restoration, infrastructure qualification, user access management etc, Pharma 4.0.

Presentation and communication of data to stakeholders, work in collaboration with the teams within and across the department. Ph.D in Life Sciences, Pharmacology, Biotechnology, Biological Engineering.

Operation and Calibration of HPLC Waters and SHIMADZU, GC, UV, FTIR, K, F, MS, IC and other instruments, Instrument Qualification knowledge required. Analysis of Raw material and Excipients and handling of HPLC Waters and SHIMADZU, GC Agilent, UV, FTIR, K/F, AAS, 1C and other instruments

Review of Literature and patents and preparation of Pre-product development strategy. Execution of experimental work and reporting of observations. Compilation of pre-formulation data on the drugs and excipients used in the formulations. 

Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. Preparation of method validation/verification protocol.

B.Pharmacy or Approved Diploma in Pharmacy from an Institute recognized by the Pharmacy Council of India and registered as Pharmacist under the Pharmacy Act 1948. Min 03 Yrs experience.

Biocon Biologics is driven by a strong sense of purpose and the unwavering commitment to serve patients and healthcare systems across the globe by unlocking equitable access to high quality biosimilars.