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Senior Compliance Specialist

Senior Compliance Specialist

West Pharmaceutical ServicesDublin, Leinster, IE
18 days ago
Job description

Job Summary

Sr Assoc, Quality Systems is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements. The role will serve as the subject matter expert and administrator for change control documentation.

Essential Duties and Responsibilities

  • Oversee overall global Change Control process; leading change control review board activities (documentation, data, customer notifications and approvals, etc.)
  • Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.
  • Assist change owners to outline action plans, tasks and responsibilities to ensure execution of changes occur in a timely manner
  • Drives visibility and oversight to changes across network to ensure applicability and consistency.
  • Oversees assessment of change controls and assures change Impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e. combination products).
  • Ensure change control information is accurately entered into the appropriate tracking database
  • Provide mentoring and training to change owners on change control processes and tools
  • Work with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications.
  • Monitor and communicate metrics and trend reports to management for the Change Control system as needed
  • Collaborate on cross functional teams in determining specification content.
  • Perform evaluation of change control processes and tools to drive continuous improvement activities.

Additional Responsibilities

  • Ensure adherence to corporate Quality System requirements

    • Education

  • Bachelor's Degree in Science or equivalent experience required and
  • Master's Degree in Science or equivalent experience preferred

    • Work Experience

  • Minimum 5 years of experience in regulated Quality Assurance / Quality Control required and
  • Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferred

    • Preferred Knowledge, Skills and Abilities

  • Ability to work independently, multi-task and thrive in fast-paced environment
  • Excellent critical reading and writing skills
  • Must have effective problem solving and interpersonal skills
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • Problem solving including root cause failure analysis methods
  • Planning / organizational skills
  • Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
  • Able to comply with the company’s safety policy at all times
  • Knowledge of cGMP, cGDP

    • License and Certifications

    Travel Requirements

    5% : Up to 13 business days per year

    Physical Requirements

    Sedentary-Exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

    Additional Requirements

  • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
  • Maintain high attention to detail, accuracy, and overall quality of work.
  • Effectively communicate and interface with various levels internally and with customers.
  • Able to be aware of all relevant SOPs as per Company policy and Quality Manual
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    Compliance Specialist • Dublin, Leinster, IE