Specialist QA - Equipment Validation

Accountabilities

• Perform QA support and oversight for validation of equipment, automation and information systems.
• Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
• Provide guidance and direction to operations staff in regards to compliance with quality policies, standards and procedures.
• Provide quality engineering support for testing strategies and quality investigations.

Responsibilities

• Process, equipment and IS validation
• Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
• Reviews and approves validation documentation.
• Maintenance & Engineering support
• Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)
• Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance)
• Device and combination product
• Manages ABR's device responsibilities and ensures alignment with GMP regulations.
• Quality Risk Management (QRM)
• Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance)
• Ensures alignment of site Quality Risk activities with corporate policy and strategy.
• Reviews quality risk assessment reports.
• Change control
• Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
• Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.

Minimum Requirements

• Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
• 5-8 years of professional experience in GMP environment
• Relevant experience in Equipment and Automation Validation
• Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Proven experience with risk management tools such as FMEA, etc.
• Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.

Competencies

• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Good understanding of quality engineering tools.
• Keeps overview but also deep dives when appropriate
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Good attention to detail and excellent writing skills.
• Good decision making skills and ability to apply risk based approach.
• Teamplayer, constructively working together towards solutions.

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Important: job fraud

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