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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 pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective 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 every day.
 
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients.  Power your future & join our bold team.
 
Position Overview
 
The Senior Validation Analyst will be responsible for supporting the development and maintenance of the validation program within Bioscience Laboratories (BSL) in accordance with all corporate standards, Ministry of Health regulations, and emerging trends within industry.  
 
Main Areas of Responsibilities:
 
  • Maintain the validation program for computer systems, facilities, equipment, manufacturing processes, and cleaning activities
  • Responsible as the Site Quality subject matter expert and technical leader for validation study methods, design and regulatory requirements
  • Work with Allergan SMEs to develop and execute analytical method validations
  • Ensure timely execution,  review, and approval of Validation protocols/reports and SOPs
  • Support regulatory changes through the provision of necessary validation documentation and change control activities
  • Support   the regulatory   defense   of   validation   protocols   and summary   reports during   regulatory inspections and internal audits
  • Support the continuous improvement initiatives for the validation of BSL manufacturing processes, equipment, and facility, utility, and control systems
  • Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements. Collect and analyze data to make data driven recommendations/decisions.
  • Use engineering or scientific background to understand the technical aspects of validation to create strategies consistent with the operational and compliance needs
  • Build and maintain successful cross-functional relationships with internal customers such as Manufacturing Science, Quality/Manufacturing, CMC, Westport, Regulatory, and WWQA
Requirements:
  • Minimum of 6 years’ experience within validation, QA/QC, and or manufacturing is required.
  • Experience  using  statistical,  risk  assessment,  experimental  design  and  process  improvement  tools  is  also required.
  • Previous experience in Quality Assurance, Quality Control, Manufacturing or Engineering is desired, but not an absolute requirement.
  • Additional Requirements:
  • Excellent written and verbal communication skills.
  • Good interpersonal skills plus the ability to work in a diverse working community.
  • Good analytical skills, detail oriented with proven organizational skills.
  • Hands on Experience:  Direct experience in the creation and execution of validation protocols.
  • Previous experience with regulatory inspections and responses.
  • Collaborative Leadership: Ability to influence with or without authority, manage expectations and ensure alignment.
  • Planning and Organization:  Excellent planning and prioritization skills with the ability to multi-task and adapt.
  • Analytical  Problem  Solving:  Ability  to  identify,  define  and  resolve  problems  using  a  structured methodology.
  • Technical Expertise:  Thorough understanding of validation concepts, current and emerging trends
 
Education
  • BA/BA in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering; MS in technical field highly desired.

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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