Senior Quality Control Manager

14 hours ago

Charlotte Bay, Australia beBeeQuality Full time $120,000 - $150,000
Quality Assurance Specialist

The Quality Assurance Specialist plays a pivotal role in upholding the integrity of our quality systems and ensuring adherence to all applicable regulations and internal standards.

Our ideal candidate will be responsible for:

Key Responsibilities
  • Audit Management: Plan, schedule, and execute internal and external audits to assess compliance with regulatory requirements.
  • Audit of Contract Manufacturing Organizations (CMOs) & Vendor Qualification: Conduct audits of CMOs and manage vendor qualification activities.
  • Third-Party Audits: Oversee third-party vendors responsible for international audits.
  • Documentation & Quality Management System (QMS): Maintain the Approved Vendor List and all related documentation in the QMS.
  • Supplier Corrective Action Request (SCAR) Program: Manage the SCAR program.
  • Corrective and Preventive Actions (CAPAs) & Risk Assessment: Assess audit findings for risk level and ensure timely and effective resolution of CAPAs.
  • Product Development & Investigations: Support product development, investigations, and CAPAs related to supplier and CMO operations.
  • Documentation & Metrics: Maintain thorough records of audits, vendors, and supplier documentation. Develop and implement systems to track performance and report departmental compliance metrics.
  • Training & Support: Train internal departments on quality and compliance expectations. Assist in preparing for regulatory inspections and contribute to audit readiness initiatives. Provide ongoing support to the broader Quality Assurance team.
  • Risk Assessment & Process Improvement: Identify areas of potential non-compliance and recommend improvements to reduce risk.

Required Skills and Qualifications

  • Strong understanding of quality management systems and regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to analyze data and identify trends.
  • Strong problem-solving and analytical skills.
  • Proficiency in MS Office Suite and enterprise software such as SAP.

Benefits

This is an excellent opportunity to work in a dynamic and growing organization, with a competitive salary and benefits package.

Others

We are an equal opportunities employer and welcome applications from diverse candidates.

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