We are a research-driven biopharmaceutical company, built on the premise that following science can lead to great medicines making a significant impact worldwide. Our mission is dedicated to inventing medicine and vaccine innovations that make a difference for patients globally.
The Specialist, Biologics Development Quality plays a key role in supporting our development programs, ensuring reliable availability, quality, and regulatory compliance of biologics supplies produced at our facility. This involves developing and implementing effective and efficient compliance and business processes with a strong operational focus aligned with business drivers.
Responsibilities:
* Provide Quality Assurance (QA) support for in-house manufacturing programs (clinical phase I - III), including compliance monitoring, QA review of batch release documents, and act as QA approver for change controls, deviations, and Corrective and Preventive Actions (CAPAs).
* Support campaign readiness by releasing starting materials and incoming goods.
* Participate in quality-on-the-floor initiative.
* Assist in creating and maintaining QA policies, Standard Operating Procedures (SOP's), and reports in line with site/global requirements.
* Maintain a proficient level of knowledge related to specialized area of technical expertise.
* Participate in risk management activities in line with relevant guidance and best industry practice.
* Foster strong relationships with management and colleagues to drive a safe and compliant culture in our Research & Development facility.
* Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
* Strong compliance knowledge and understanding of regulatory agency regulations and requirements, participating in onsite inspections and supporting audit findings resolution.
Your Profile:
* 3 years' experience in pharmaceutical industry in a QA function.
* Strong background in Current Good Manufacturing Practice (cGMP), risk management, investigations, problem-solving.
* Strong written and verbal communication skills.
* Ability to think logically and be proactive under pressure.
* Ability to work as part of a team and on own initiative in a constructive manner.
* Strong attention to detail and precision in preparing and reviewing GMP documentation.
* Experience interacting with regulatory officials and quality management systems such as Veeva, SAP, PAS-X would be beneficial.
Our Quality Assurance group ensures every material inside our products meets high standards of quality and meets all regulatory requirements. We create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.