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Compliance Specialist Operations Mt. Vernon, IN

6.00 to 11.00 Years   Bangalore   18 May, 2022
AstraZeneca
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process AnalysisGeneral / Other Software
EmploymentTypeFull-time

Job Description

    The core responsibilities of the role are as follows:Support all Compliance programs and execute required Compliance activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies.Provide support to Quality Systems processes including but not limited to: Complaints, Quality Events/Deviations, CAPA, Change Control, Product Reviews, Supplier Quality, Internal Audit Program, and other Quality Systems as needed to support the site.Drive continuous improvements efforts through monitoring/evaluation of site systems & processes against current Compliance requirements and influencing key stakeholders on recommended Compliance improvements.Support inspections of site by External Customers, internal assessors, and Regulatory authorities.Education, Qualifications, Skills and Experience:EssentialBachelors degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering.3 years industry experience and/or FDA experience.Excellent oral and written communication skills.Strong ability and motivation to learn.Ability to collaborate and participate in multi-disciplinary teams.Knowledge of global regulatory and cGMP requirements, industry best-practices.Familiarity with production operations.Strong technical writing.Strong interpersonal, communication, and influencing skills.Desirable2+ years in QA/Regulatory Compliance in the pharmaceutical industry.Experience managing Quality SystemsWhy AstraZeneca At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means were opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together.So, whats next Are you already imagining yourself joining our team Good, because we cant wait to hear from you. Apply today!,

Keyskills :
complianceformsadministrative supportanalysis

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