GMP Quality Consultant

Company: Eliassen Group
Location: Palisades Park
Posted on: June 11, 2022

Job Description:

We have an excellent job opportunity available as a GMP Quality Consultant with a Pharmaceutical client of ours. If you are looking for a job that impacts others, then this is the job for you! Responsibilities of the GMP Quality Consultant: Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan Responsible for reviewing batch documentation, data, certificates of analyses, technical reports Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required Supporting batch disposition processes as required Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of R&D Quality & Clinical Operations departments Identify and escalate regulatory issues and trends pertinent to the products and O&B business to management, as appropriate Receive overall project direction from management, but completes most work independently Complete required training and keep training files current Additional tasks and duties as assigned Requirements of the GMP Quality Consultant: Bachelor of Science (BS) degree and 3+ years' experience in QA compliance and/or QA Product Disposition area in the pharmaceutical/biotech industry Knowledge of cGMP regulations for US, EU and other markets Effective time management, detail-oriented work style, and superior at teamwork and collaboration Excellent organizational, presentation development and delivery skills Proficient computer, verbal and written communication skills Strong problem solving and data analysis skills Job ID: 367911 About EG Life Sciences: Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions. Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

Keywords: Eliassen Group, Tenafly , GMP Quality Consultant, Professions , Palisades Park, New Jersey