Job Description: QA Project Specialist – Change Control

A leading pharmaceutical organization is seeking a QA Project Specialist to play a vital role in ensuring quality assurance across change control initiatives. This position is instrumental in maintaining compliance with cGMP regulations and serves as a key liaison between multiple departments. The ideal candidate brings a proactive mindset and in-depth knowledge of quality systems within a pharmaceutical setting, contributing to the continuous improvement and efficiency of critical processes.

Key Responsibilities:

• Change Control Project Management
  Lead and contribute to change control projects within a production environment. Represent the QA department in project teams and ensure validation requirements and quality standards are met.

• Compliance & Quality Advisory
  Act as a Subject Matter Expert (SME) on compliance and quality assurance. Evaluate and monitor the quality impact of changes, and provide guidance during audits and regulatory inspections.

• Data Integrity & Master Data Oversight
  Ensure adherence to change control procedures, including documentation, reporting, and system integrity. Manage Master Data and ensure reports are complete, accurate, and aligned with internal and external standards.

• Policy Development & Implementation
  Develop and implement change control policies across the organization. Translate strategic goals into practical procedures, and provide training and coaching to uphold quality standards.

• Stakeholder Coordination
  Collaborate with internal and external stakeholders to align on quality initiatives. Promote buy-in through tactful communication and strong influencing skills.

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

Asha Longman

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