AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Reporting to Quality Assurance Manager/Responsible Manager, the responsibilities of the incumbent are;
•Providing quality assurance support for the quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics.
•Responsible for all product, process or system related quality activities supporting the business from receipt of final product through final product release of finished goods based on approved specifications and in compliance with Corporate, governmental and local regulations and requirements.
•Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze and trend quality indicators, data and performance metrics.
•Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
•Ensure QA checking of the label development process on PPLS system.
•Ensure preparation of the annual PQR for overlabeled products
•Ensure investigation of 3PL quality events such as deviations, non-conformances, customer complaints , returns and corresponding action plans including decisions. Ensure 3PL metrics and KPIs are being met.
•Perform incoming control of products and printed packaging materials.
•Support and investigate quality events such as exceptions, CAPA’s, product complaints, returns and corresponding action plans including decisions.
•Provide guidance and support for all activities governed by GDP and GMP including monitoring of controlled temperature and cold chain shipments.
•Proactively develop customer relationships by making efforts to listen to and understand the customer (both internal and external); anticipate and provide solutions to customer needs; give high priority to customer satisfaction.
•Degree in Chemical Engineering, Chemistry, Pharmacy, Biology or other scientific area
•4-5 years of Quality Assurance/Quality Control experience in pharmaceutical industry
•Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
•Analytical strength with proven ability of results orientation, good follow-up and attention to detail
•Multi-task to work concurrently with numerous stakeholders/projects. Enjoy working proactively
•Excellent interpersonal skills and strong presentation skills
•Proficiency in English
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.