Quality Assurance Specialist
hace 4 semanas
Quality Assurance Specialist
Pharmalex is a leading consulting company for the Healthcare industry, offering professional development, training, competitive compensation, and a stimulating work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
We are seeking a Quality Assurance Specialist to provide services in Quality Systems, including Deviations, CAPA, and Change Control. The ideal candidate will have expertise in electronic systems, such as Documentation platforms, Maximo, Trackwise, LIMS, electronic batch record (MES), and SAP. Additionally, the candidate should have experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
The successful candidate will be responsible for leading, influencing, and negotiating with regulatory agencies and evaluating compliance issues. Strong communication, facilitation, and presentation skills are essential, as well as the ability to interact with regulatory agencies and evaluate compliance issues. The candidate should be fully bilingual in English and Spanish and have a Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience in Sciences or Engineering.
Pharmalex is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
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