Quality Specialist

  • Tipperary
  • Temporary 12 months FTC
  • JO-1901-64167_1548150826

Summary

The position will provide an opportunity to develop strong Quality and Technical understanding of Operations and Compliance requirements in the Pharmaceutical Industry.


Responsibilities:

  • Attend and actively contribute to daily Tier meetings.
  • Complete pre and post production batch record review
  • Support development, clinical and commercial production
  • Release incoming materials
  • Provide Quality support OOS/deviations, providing detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
  • Review and approve master cleaning documentation, including; technical assessments, cleaning protocols, inspection protocols and Master Cleaning Batch records.
  • Generation of Technical & Quality agreements
  • Annual Process and Systems Reviews: Prepare and coordinate the review and approval of the Annual Product Review Schedule. Prepare annual process and systems reviews, including the annual mock recall, as determined by the Annual Product Review (APR) Schedule.
  • Investigate Supplier Complaints / Raw Material Deviations / Customer Complaints
  • QA Review of Regulatory Data: Review and verify documentation that may be used for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program.
  • Lead walk down audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • Participate in Quality and site projects that may arise.


Requirements:

  • Bachelor's degree or post-graduate qualification in Science, Pharmacy or Engineering field.
  • Previous experience in Quality Assurance / Compliance.
  • Excellent understanding of the current pharmaceutical industry regulations (FDA/EU/ICH).
  • Practical experience in the implementation of quality systems in a pharmaceutical manufacturing environment.
  • Preferred Competencies and Skills:
  • Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
  • Knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.
  • Hands-on experience in investigation root cause analysis
  • Demonstrated ability to make and act on decisions
  • Ability to provide innovative ideas to improve quality and compliance that create value.
  • Experience supporting regulatory inspections
  • Analytical problem-solving skills applied to issue identification and resolution
  • Assertive, a very strong communication

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