Allergan Senior Project Engineer, Quality Assurance Compliance in Waco, Texas
Senior Project Engineer, Quality Assurance Compliance
Waco, Texas, United States at http://agn.referrals.selectminds.com/jobs/545/other-jobs-matching/location-only
6 hours agoPost Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Project Engineer, Compliance is responsible for managing the Waco facility’s Compliance activities in accordance with the FDA Code of Federal Regulations, European Regulations, and other Ministry of Health regulatory requirements; including participating in regulatory audits, and internal and external supplier audits.
Main Areas of Responsibilities
The responsibilities for this position include:
Serves as the site liaison for FDA/DEA and other MOH inspections, third parties, and suppliers. to.
Facilitates identification and preparation of documents needed to support on-site and off-site regulatory requests and audits.
Reviews and audits documents/records prior to submission for accuracy.
Investigate and determine the root cause, identifies mitigation and remediation in response to audit observations, determine, .
Plans, prepares and documents written responses for investigations and MOH responses.
Performing Quality Assessments and Excipient Risk Assessments.
Planning, preparation, and documentation of audit activities including: execution and follow-up of internal audits and supplier audits to ensure that the Waco facility is in an audit ready mode at all times.
Preparing documented assessments of new or revised regulations and developing mitigation/remediation plans and communicate the changes for any gaps that have been identified to affected groups.
Identify and communicate regulatory inspection trends to the affected groups.
Performs other tasks/duties as assigned by manager.
- Four (4) years’ experience in Pharmaceutical and/or Medical Device in an Operations, Regulatory or Quality Assurance function.
Knowledge of cGMP’s and global regulations.
Strong general Quality System knowledge and aseptic processing knowledge.
Able to understand, interpret and present information to show how Allergan’s processes and records meets regulatory requirements.
Ability to organize, develop, and prepare written investigations and responses to MOH.
Ability to interface and interact with all levels of personnel within and outside of the organization and globally.
Strong interpersonal and presentation skills with the ability to communicate clearly and professional, written and verbally.
Must be able to critically think through opportunities and use a variety of problem solving methods.
Proven ability to plan, execute, document, and follow up on internal and external audits.
- Bachelor’s degree in Sciences, Engineering or related field