Company Jobs

With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity

To be an integral part of an antibody development team with a focus on performance and specificity using innovative molecular, protein, and cell biology methods.

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Autonomous with strong self-motivation and ability to work independently as well as in a highly collaborative and multicultural environment within short timelines.

Preparation of additional information or responses as requested by regulatory agencies. Prepare or maintain technical files as necessary to obtain and sustain product approval. Direct the collection and preparation of laboratory samples as requested by regulatory agencies. 

Pharma knowledge of Solid orals & Quality process. USFDA, MHRA, ANVISA & Other regulatory exposure is preferred including ICH guidelines.

Analytical Method development. Handling HPLC, GC, UV IR, KF, Dissolutions

FFS, LVP, Flow wrapping, SHWSS, Terminal Sterilizer, Dry powder injection, Injection Labelling, Capsule Filling, Compression, Granulation, Coating

Experience in metabolite identification studies including proposing potential metabolite structure and determination of tentative structures of metabolites and their product ions from the LC-MS/MS data