QC Equipment and Systems Specialist

at  WuXi Biologics

As QC Equipment and Systems Specialist, you will be responsible for will be responsible for supporting Equipment Introduction and Qualification in the QC Analytical workstream and to deliver tasks on time as per the project schedule.

ORGANIZATION DESCRIPTION

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world’s top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

DEPARTMENT DESCRIPTION

As QC Equipment and Systems Specialist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QC Equipment and Systems Team Lead.

EXPERIENCE

• 3+ years experience working in a fast-paced environment.
• Experience in a GMP facility, in a lead or project manager role is desirable.
• Experience with facility start-up projects (brown field or green field) is desirable.

KNOWLEDGE

• Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage.

QUALIFICATIONS

• Diploma / degree qualification is desirable.

• Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle including URS, RTM, IOQ etc.
• Preparation and review of required validation documentation including protocols and reports.
• Ensure data integrity requirements are included and met as part of the new instrument qualification.
• Establishment of procedures for management and maintenance of the validated system.
• Authoring, review and approval of qualification/validation protocols and reports and status reports.
• Periodic review of instrument qualification packages as required.
• Initiate Change Controls for any new equipment identified as part of the NPI (New Product Introduction) programme and for changes on existing equipment.
• Manage Instrument and equipment validation, calibration and maintenance scheduling.
• Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
• Deliver on equipment Release timelines.
• Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required.
• Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements/issues.
• Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.
• Proactive engagement with customers and key stakeholders.
• Maintain the QC laboratories in a state of audit readiness at all times.
• Participate in and drive the continuous improvement of all aspects of the group.
• Ensure compliance with cGMP, corporate standards, site policies / procedures, and regulatory requirements.
• Attend tier meetings providing updates on QC Equipment and escalations where applicable.
• Identifying and monitoring key milestones and addressing issues that may impact the critical path of the schedule.
• Manage other QC schedules as required e.g. Equipment PM/PV, periodic reviews, calibrations to ensure there is no impact to the QC Laboratories.
• Support the Continuous Improvement process to eliminate procedural and scheduling inefficiencies.
• Engage and manage stakeholders effectively, resolving issues and understanding drivers/needs. Being aware of potential risks and escalate if necessary.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents as required.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the QC management team.
• Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values.