Job Role: QA Engineer About the Role:
We are looking for a proactive and detail-oriented QA Engineer to join our Quality Assurance team. In this role, you will ensure the integration of quality standards across system qualification, maintenance, and asset management activities. You will play a key role in maintaining compliance with cGMP and regulatory requirements, supporting qualification projects, and continuously improving our quality systems and processes.
Key Responsibilities:
Integrate quality standards to mitigate risks during asset management design reviews.
Ensure compliance and quality oversight of qualification activities.
Review and approve calibration and maintenance records, certification master data, and eSTREAM notifications.
Evaluate and approve change control, deviation, and CAPA records related to qualification and lifecycle activities.
Participate in system introduction and change projects, ensuring regulatory compliance.
Maintain qualification status throughout the lifecycle of facilities, systems, and equipment.
Prepare for and participate in internal, customer, and regulatory audits as QA representative.
Collaborate cross-functionally to ensure project timelines and compliance objectives are achieved.
Continuously assess and improve qualification and system quality processes.
Key Competencies:
Strong analytical and risk assessment skills.
Excellent communication and collaboration across teams.
High attention to detail with a commitment to compliance and quality.
Problem-solving mindset and ability to drive continuous improvement.
Knowledge of pharmaceutical qualification, maintenance, and data governance.
Requirements:
Master’s degree in Engineering, Pharmacy, or a related scientific discipline.
Minimum 5 years of experience in the pharmaceutical industry.
In-depth knowledge of pharmaceutical legislation, cGMP, and qualification guidelines.
Experience with systems such as Comet (change control), eStream (maintenance management), TrüVault (document management), Summit (training), and Kneat (qualification documentation).
Fluent in Dutch and English, both written and spoken.
Practical Info:
Location: Beerse
Duration: End of 2025
Start Date: ASAP
Work Model: 40 hours per week
Interested or know someone who might be?
Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.