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PharmaLex is a highly successful and growing consulting company for the Healthcare industry.
PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment.
We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.
General Description: We are looking for resources to provide services as a Specialist QA.
Requirements: Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
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.
Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications.
Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Strong communication (both written and oral), facilitation and presentation skills.
Fully Bilingual in English and Spanish.
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience years of directly related experience Sciences or Engineering PharmaLex is an Equal Opportunity Employer.
We are 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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