Job description
Equivalent ExperienceDescription:
3 systems in scope for the ASC at W R Grace System 1 (OMC system) – 2 product variants, MS 3000 method development and data generation on the MS 3000 only (will compare with data generated at R&D lab) System 2 (Shared system) – 10 product variants, assume MS 3000 data and method development for all 10 variants and MS 2000 control data on 8 of the 10 variants. We would hope not to have to have 10 different methods but that maybe 1-3 methods would cover all variants. System 3 (ECAT system) – awaiting Autosampler from Malvern (no confirmed timeline). Will consider PQ without autosampler if needed to run behind other 2 units. Single product variant. Assume for quote that we need MS 2000 and MS 3000 data but we may well only the need the method development and the MS 3000 data. Must have experience with Mastersizer, Minitab and Experience with method validation and method transfer. Must have 5 years + of the above skills.
Skills:
Validation, Validation protocols, Gmp, Pq, Oq, Iq, Mastersizer, Method validation, Technical writing, Minitab, method development
Top Skills Details:
Validation,Validation protocols,Gmp,Pq,Oq,Iq,Mastersizer,Method validation,Technical writing,Minitab,method development
Additional Skills & Qualifications:
Preferer technical degree (BS or higher).
Experience Level:
Expert Level
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