Education and/or Experience

Bachelor’s degree in Sciences with at least seven (7) years related experience in the pharmaceutical industry processes. Candidate must have at least three (3) years hands-on experience in solid dosage manufacturing or process development to provide sound input to the Chemical, Manufacturing, and Controls (CMC) section of dossiers from both an Operations’ and Quality unit perspective.

Prior experience external and internal quality auditing of manufacturing and/or process development processes highly desired. Candidate must be a strong project manager; with at least three (3) years of experience in leading projects.


Language Skills
Fully Bilingual (English & Spanish). Ability to read, analyze, and general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.


Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical concepts. Ability to apply concepts such as normal distribution, percentages, ratios, and proportions to practical situations.

Computer Skills

Basic to intermediate knowledge of Microsoft Word, Excel and Outlook. Basic to intermediate knowledge of SAP, Global LIMS, LDMS, and TrackWise/GCM applications.


Description of Duties

To participate and support the quality assurance activities within the New Products Process Execution Team (PET), support areas, and related projects by ensuring compliance with GMP’s, regulatory agencies, and AstraZeneca policies. Assure consistency between the quality systems for new and existing systems. Provide input to the CMC documents based on pharmaceutical process knowledge from an operations’ perspective.