Job description
ABOUT THE JOB
- Ensure adherence to Change Control management systems and processes in alignment with site and global quality standards.
- Evaluate Change Control requests for process, validation, regulatory, and product impact.
- Coordinate and track the review and approval process to ensure timely and compliant execution of changes.
- Collaborate with cross-functional teams and departments to ensure effective and efficient implementation of change control activities.
- Ensure all site changes are managed appropriately to meet expectations of the global change control board and site project timelines.
- Support and participate in cross-functional and cross-site change management forums to align practices and share best approaches.
- Assist in the development and delivery of training materials and qualifications for Change Control processes and related applications.
- Perform Change Records review in support of Annual Product Review (APR) activities.
- Support regulatory inspections and audits, including documentation review and presentation of QA processes.
- Ensure compliance with cGMP, safety, and security regulations while maintaining and continuously improving Change Control processes.
ABOUT YOU
- Academic background in Life Sciences, Biotechnology, Pharmacy, or related field.
- 1–3 years experience in quality assurance within pharmaceutical manufacturing (ideally with exposure to bioprocess environments).
- Experience with Quality Assurance and Change Control processes
- Experience with cGMP compliance and regulatory requirements
- Experience with cross-functional collaboration and stakeholder management
- Experience with training delivery and development of training materials
- Experience with audit support and documentation review
- Familiarity with QA systems such as QEM or TrackWise.
- Ability to conduct investigations and manage deviations independently.
- Proficiency with QA management tools and Change Control applications
- You have strong organizational, communication, and problem-solving skills
WHY AMARIS?
At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact.
Here’s what you can expect when you join our dynamic community:
- Global Diversity: Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
- Trust and Growth: With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
- Continuous Learning: Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
- Vibrant Culture: Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.
- Meaningful Impact: Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.