Quality Assurance

1 dag geleden

Breda, Noord-Brabant, Nederland Real Voltijd

Quality Assurance (Validation / Packaging / PASX master data)

Pharma industry

Breda

40 hours per week

Accountabilities

  • Perform QA oversight for validation of equipment and packaging qualification
  • Perform review and approval of equipment validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
  • Provide quality support for testing strategies and quality investigations.
  • Perform review and approval of master data in the electronic batch record platform (PASX).

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, …)
  • Device and combination product
  • Manages ABR's device responsibilities and ensures alignment with GMP regulations.
  • PASX master data
  • Review and approved master data in PASX system as QA.
  • 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.
  • Deviation management
  • Functions as QA contact for deviation records.

Minimum Requirements

  • MBO or Bachelor's degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.
  • Typically 3 years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
  • Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.
  • Manufacturing and/or Quality analytical processes and operations.
  • Fluent in English language.

Preferred Requirements

  • Experience with pharmaceutical industry
  • Experience with Deviations and Change Control

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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