QA In Process Engineer

About Vantive

Vantive is dedicated to innovating vital organ therapies, with a 70-year heritage in kidney care. Our mission is to enhance lives by improving dialysis through digital and advanced services while expanding beyond kidney care. Our goal is to provide care teams with more flexible and efficient therapy administration, resulting in longer, better-quality lives for patients globally. Joining Vantive means becoming part of a driven community focused on meaningful impact in patient care.

Role Overview

As a QA In-Process Engineer, you will be integral to quality assurance within manufacturing operations by overseeing batch record review, managing product complaints, driving CAPA efforts, and supporting compliance and audits.

Key Responsibilities

• Examine completed production batch records and make recommendations for batch dispositions.
• Assist in batch release processes ensuring alignment with GMP and quality standards.
• Handle product complaint investigations, ensuring timely and effective resolutions.
• Support corrective and preventive action (CAPA) processes and ensure timely completion of quality tasks.
• Review and prepare GMP-related documentation such as SOPs and work instructions.
• Engage in process improvement initiatives to enhance operational efficiency.
• Collaborate across functions to address quality challenges and improve performance.
• Manage specific quality projects and contribute to overall site quality goals.
• Support internal, customer, and regulatory audits and inspections.
• Compile and deliver quality performance reports and management updates.
• Participate in achieving departmental KPIs and continuous improvement efforts.

Candidate Profile

• Experience in pharmaceutical, biotech, medical device, or regulated manufacturing environments.
• Comprehensive knowledge of Quality Assurance principles and GMP regulations.
• Effective communication and interpersonal skills.
• Strong problem-solving and critical thinking capabilities.
• Proven ability to work cooperatively within cross-functional teams.
• Skilled in technical writing and documentation preparation.
• Ability to prioritize tasks and work autonomously.

Personal Attributes

• Results-driven and accountable.
• Innovative with a solution-oriented approach.
• Adaptable to dynamic work environments and shifting priorities.
• Team-oriented with a strong focus on customer satisfaction and quality.
• Influential collaborator across multiple departments.
• Committed to continuous improvement and operational excellence.

Benefits Package

• Competitive remuneration plus annual bonus opportunity.
• Pension scheme participation.
• Extensive health and wellness programs.
• Employee Assistance Program (EAP).
• Life insurance and income protection coverage.
• Generous paid leave entitlement.
• Flexible and hybrid work options depending on role requirements.
• Access to learning and growth initiatives.
• Career advancement and internal mobility prospects.
• Recognition and rewards programs fostering a supportive culture.
• Inclusive work environment with collaborative values.
• Opportunity to significantly impact the lives of patients worldwide.

Additional Information

Reasonable Accommodation: Vantive is committed to providing appropriate accommodations for candidates with disabilities throughout the application and interview process upon request.

Recruitment Fraud Warning: Be aware of fraudulent recruiters posing as Vantive representatives aiming to obtain personal or financial information. Exercise caution and refer to official channels for verification.