Performing the periodical system washing of HPLC systems related to method development group. Responsible for calibration of HPLC and UPLC, 1C and dissolution apparatus.
2-8 years into receipt & dispensing activity, inward & outward activity. 2 to 8 years of experience into API / Intermediates Manufacturing. 2-5 years of experience in Granulation, Coating, Compression, Blister Secondary and Cartonator, Bulk Secondary
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
Candidate should have experience with the GEA Granulation line, compression processes in the oncology sector, and coating with Glatt and ACG equipment. Experience in handling regulatory audits is a must. Proficiency in English communication is required.
Execute and manage developmental project activities, participate in screening and generation of new opportunities in emerging drug delivery systems in order to contribute to the overall Research and Development goal of the organization.
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.
Execute, monitor, report and interpret preclinical, clinical and BABE studies at CROs to support various regulatory submissions within targeted timelines, budgets, quality and regulatory guidelines; identify health hazard and assess risks associated with pharmaceuticals, chemicals, intermediates, impurities, etc. by toxicological review and derivation
Establish long-term relationships with potential clients, partners, and distributors in the region to drive business growth. Lead negotiations and close deals related to contract manufacturing, development services, and out-licensing agreements.