No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
Key Responsibilities:
Ensure adherence to the Change Control management systems and processes.
Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed.
Evaluate Change Control requests for process, validation, regulatory and product impact.
Coordinate the review and approval process of change requests to ensure timely execution of changes.
Ensure all site changes are managed appropriately to meet the expectation of the global change control board (if applicable) and meets site project timelines.
Participate in cross functional and cross site change management forums.
Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process.
Ensure completion of required change control actions prior to lifting lot disposition restrictions.
Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications.
Perform Change Records review in support of Annual Product Review activities. Ensure maintenance and continuous improvement of change control and processes.
Support regulatory inspections and provide audit support with your team, which may include presentations and facility, utility, equipment documentation review.
Education:
Degree in (e.g. Life Sciences or Engineering) discipline or equivalent.
Experience (may vary depending on site size/scope):
0-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience is preferred.
Related working experience in a biotech or pharmaceutical operating environment is a plus.