Company Jobs

interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.

Responsible for timely preparation of collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs. To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages, preparation of packaging and QC testing instructions and assigning periodic re-test intervals.

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

IPQA, Validation, QMS, Documentation, Compliance. Filling, Sealing, Autoclave, Compounding, Lyo, Visual Inspection, Vial Washing, Vial Collection, Vial Packing.

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.