QA Specialist II

  • Cork
  • Temporary 12 months
  • JO-1902-64233_1552383600

Summary

Responsibilities

  • Acts as the day-to-day QA project contact person for the Manufacturing and Engineering departments providing guidance / feedback on quality issues related to their respective area project activities.
  • Completes the review/ approval of Manufacturing and Engineering project documentation - in particular equipment/ process/ automation validation documentation.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Actively contributes to continuous improvement initiatives.
  • Builds and maintains good working relationships with Engineering, Manufacturing and Quality department personnel in particular.
  • Supports the preparation for regulatory and customer GMP inspections of the site in addition to performing and co-ordinating internal audits.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to ensure they are implemented and accurately documented in a timely manner.
  • Participates in developing Standard Operating Procedures (SOP's) to ensure quality objectives are met.
  • Participates in site cross-departmental teams as the QA representative - Attending associated meetings ensuring QA is represented & its concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process.
  • Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
  • Ensures compliance with all site safety-related procedures and practices.

Requirements

  • Minimum of 3 years of relevant experience and a BSc.
  • Experience in the review/ approval of Validation documentation essential.
  • LEAN and Six Sigma philosophy are embedded in your day to day working.
  • Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
  • Demonstrates proficient knowledge of FDA/EMA regulations, guidance's and current Good Manufacturing Practices (GMPs).
  • Demonstrates ability to work effectively in a team environment, contributing with a positive and constructive attitude.
  • Demonstrates solid verbal, written, and interpersonal communication skills.
  • Must be able to exercise judgement within generally well-defined and established procedures and practices to determine appropriate action(s).
  • Demonstrates independent action and initiative in resolving issues.
  • Demonstrates ability to prioritise and meet deadlines.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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