vacancies

eCTD Compilation, validation, and submission to Health Canada and US through ESG gateway for New Submission ANDS, NDS, Deficiencies response Clarifax, SDN, NOD, NON, Supplements submissions

Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing or fresher also apply. Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing.

Able to conceptualize and design novel vectors across expression systems including bacterial, yeast, mammalian, gene modification techniques. Experience in mass spectrometry for protein, antibody analysis.

Verify the accuracy of transcribed data by cross-referencing with original sources and ensure an accurate presentation of data in the report. Ensure that all transcribed data complies with internal quality standards and external regulatory requirements.

Conduct in-depth research and analysis of rare disease markets, including competitive landscape, market dynamics, and emerging trends. Develop and maintain a comprehensive understanding of the rare disease market, including key players, product portfolios, and future opportunities. Collaborate with cross-functional teams to gather and synthesise relevant data and insights to support strategic decision-making.

QA Specialist will serve as QA technical subject matter expert for CSV process, such as MES, KNEAT, DCS, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools.

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.

12th pass in science subject and Diploma in Pharmacy from a recognized institution, Board. Experience in dispensing and or storage and dispensing of drugs in a reputed hospital or institution or in a drug store or a pharmaceutical concern.

Relevance of Mycobacterium tuberculosis biofilms in tuberculosis pathogenesis and drug tolerance. Masters, Integrated Masters in Natural or Agricultural or Pharmaceutical Sciences, MVSc, Animal Sciences.