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O firmie AbbVie

Misją AbbVie jest odkrywanie i dostarczanie innowacyjnych leków, które już dziś rozwiązują poważne problemy zdrowotne i stanowią odpowiedź na medyczne wyzwania jutra. Dążymy do wywarcia znaczącego wpływu na życie ludzi w kilku kluczowych obszarach terapeutycznych: immunologii, onkologii, neurobiologii, pielęgnacji oczu, wirusologii, zdrowia kobiet i gastroenterologii, a także w zakresie produktów i usług z portfolio Allergan Aesthetics. Aby uzyskać więcej informacji o AbbVie odwiedź nas na www.abbvie.com. Obserwuj @abbvie na portalach Twitter, Facebook, Instagram, YouTube i LinkedIn.

Quality Validation Manager

Worcester, Massachusetts Identyfikator oferty 2210615 Kategoria Quality Assurance Dział AbbVie
Purpose:
Quality Validation Manager is responsible for maintaining and ensuring plant compliance to corporate policies and procedures for Validation. The manager will lead a team of QA Validation professionals responsible for quality oversight of validation and qualification procedures / executed packages for facilities, utilities, equipment, lab instruments, computerized systems, test methods, cleaning validation, and shipping validation.
 
You Will:
  • Responsible for plant validation activities including equipment and process risk documentation (i.e., FMEA, CVRA), commissioning, qualification, and validation.
  • QA oversight in the development, review and execution of protocols, reports, and risk assessments.
  • Ensure plant compliance to the Validation program with AbbVie Quality Systems for validation to comply with 21 CFR Part 11, 58, 210 and 211, FDA regulations and guidelines.
  • Gather and evaluate data for trending and monitoring of the validation process, and as a QA validation SME, lead validation support for regulatory, internal and client audits.
  • Lead the QA Validation Review department, coordinate execution of validation activities and deliver right first time and on time execution.
  • Proactively identify, implement, and drive continuous improvement by monitoring metrics and implementing lessons learned.
  • Responsible for the planning, organization, administration and general supervision of direct staff and contract personnel.
  • Ensure employee resource allotment and workload requirements are balanced to meet the needs of the business daily as well as forecasting future work capacity based on the strategic objectives of the plant.

What You Will Have:
  • B.A. or B.S. degree, preferably in pharmaceutical, biotech, or engineering related field.
  • Minimum 10+ year’s experience with Qualification/Validation of facilities, utilities, equipment, Whatprocesses.
  • Minimum 2+ years supervisory/management experience.
  • Strong working knowledge of GMP and industry regulatory (FDA) requirements.
  • Hands-on experience in at least one of the following areas: Cleaning Validation, Process Validation, Quality System Assessments and Implementation, Auditing and Gap/GMP Assessments, Manufacturing Operations in Pharma/Biopharma, Process Engineering or Equipment, Facility and Utility Qualification.
  • Ability to analyze, investigate and provide strategies to technical and regulatory issues.
  • Strong creative problem solving and analytical skills.
WhatYou Will Receive:
  • Comprehensive Healthcare: Medical, Vision, Dental, FSA, HSA
  • Financial Well-being, Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • AbbVie Vitality: Health & Wellness programs including Employee Assistance Program (EAP), Health Advocate, Global Well-Being Programs
  • Generous Paid Time Off include, Company Holidays, Vacation, Parental and Caregiver Leave
  • Community Outreach Programs and company match of charitable contributions
  • Perks include AbbVie Product Shop, Employee Loyalty Program, Tuition Assistance, Adoption and Surrogacy Assistance, Mothers at Work and Milk Stork to list a few
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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