We are seeking a QAV Validation & Digital Specialist to support a strategic quality and digital transformation initiative.

• This role will initially focus on Quality Assurance Validation activities and will transition into a digital quality-focused function as project needs evolve.
• The ideal candidate will bring experience in digital quality systems, electronic documentation management, or manufacturing digitalization initiatives and be willing to learn and support validation processes within a regulated environment.
• Comprehensive training on company procedures, quality systems, and validation requirements will be provided.

Key Responsibilities

Initial QAV Validation Responsibilities

• Review protocols, change controls, SOPs, and validation documentation.
• Support compliance assessments and documentation review activities.
• Conduct quality reviews to ensure adherence to internal procedures and regulatory requirements.
• Participate in validation project execution and documentation management.

Future Digital Quality Responsibilities

• Support digital quality initiatives and electronic quality management processes.
• Review and manage electronic batch records and associated documentation.
• Utilize digital quality platforms and software tools to support quality operations.
• Assist with system implementation, optimization, and data-driven quality improvements.
• Partner with cross-functional teams to enhance digital workflows and process efficiencies.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Information Systems, Computer Science, or a related field.
• Experience working with digital quality systems, electronic documentation systems, manufacturing systems, or related digital platforms.
• Strong technical aptitude with the ability to learn validation and quality processes.
• Excellent organizational, analytical, and communication skills.
• Ability to adapt to evolving project requirements and responsibilities.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Familiarity with electronic batch records, quality management systems, or validation activities.
• Experience supporting digital transformation, process automation, or data management initiatives.
• Exposure to systems such as electronic documentation platforms, manufacturing execution systems (MES), or similar quality technologies.