Acts as the Technical Specialist in support of the Quality Assurance Program.
Direct experience:
:Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
:Supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
:Working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.
:Conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
:In Aseptic processing manufacturing processes.
Capable to or demonstrated ability to:
:Review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.
:Follow GMP procedures with a strong Quality and Compliance mindset.
:Conduct GMP quality inspections walk downs and general oversight to production, utilities and general facility areas with the objective to ensure the required state of Validation.
:Analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
:Communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
:Follow required Environmental Health and Safety procedures and related requirements within a GMP production environment.
:Learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
:Work in teams and demonstrate full engagement with execution plans and adherence to established due dates.
General understanding
:Manufacturing Execution Systems (MES) and electronic Batch Records (e:BR).
:Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning and Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
:Information/Computer Systems knowledgeable.
:General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
Requirements
:Engineering / Science related background.
:Project Management skills. Presentation Skills.
:Excellent Technical Writing and general Communication skills in English and Spanish.
:Strong engagement and partnership with site Management.
:Good interaction skills to enable appropriate performance supporting complex matrix organizations.
