Validation Specialist

1 week ago

Melbourne, Victoria, Australia beBeeQuality Full time $160,000 - $200,000
Key Responsibilities

The Validation Lead is responsible for overseeing qualification processes, identifying key risks and presenting issues, recommendations and updates to the relevant governance forums or processes.

Scope of accountability includes liaison with contractors, suppliers, internal customers, and management/overview (as agreed) of the qualification/validation activities through to routine use.

Initial validation/qualification activities and progression to routine requalification are also included in the scope of accountability.

How You Will Achieve It:
  • Manage multiple projects/ongoing work activities of moderate complexity.
  • Required to manage capital project qualification/validation activities according to the agreed timings and outcomes.
  • Contribute to generation of user requirements for equipment, facilities and services.
  • Liase directly with Technical Service Manager, principal engineers and Quality ensuring alignment on strategy and technology selection.
Technical Expertise
  • Develop validation strategies and validation master plans for facilities (CNC to Grade A to support sterile filling), utilities and manufacturing equipment (vial wash, dry heat tunnel, filling, freeze drying decontamination), packing lines, laboratory equipment and computer systems.
  • Integrate qualification activities to quality management systems.
Leadership and Team Management
  • Provide leadership and line management to the team, coordinating and overseeing their workloads, providing support to ensure that the team delivers effective and efficient services.
  • Perform assessment of change controls for impact on validation status and actions required.
  • Perform validation activities in accordance with quality management system, validation master plan and validation procedures.
Personal Competencies
  • Good interpersonal skills including the ability to work with all levels.
  • Sound technical/mechanical aptitude and ability to identify problems and implement resolutions.

The successful candidate will have a relevant science or engineering tertiary qualification and 8+ years of experience. Proficiency in Excel / Word / Outlook / Project/ CAD (or equivalent) is also required.

Strong analytical and problem-solving skills, good people management skills, good communication skills, proactive, good initiative and ability to work under pressure are essential for this role. Strong understanding of quality systems and cGMP regulatory requirements, experience with regulatory expectations and inspections, experience in the conduct of safe works management and EHS Compliance are highly desirable.

Requirements
  • Relevant science or engineering tertiary qualification.
  • 8+ years of experience.
  • Proficiency in Excel / Word / Outlook / Project/ CAD (or equivalent).
Benefits

Strong analytical and problem-solving skills, good people management skills, good communication skills, proactive, good initiative and ability to work under pressure are essential for this role.

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