Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU, and Asia.
The company currentlyemploys over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Job description: As a Senior QC Equipment Specialist, you will be responsible for the successful management and execution of Equipment and System Introduction and Qualification in the QC Analytical workstream and to deliver tasks on time as per the project schedule.
Organisation Description Wu Xi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries.
Were 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 a Senior QC Equipment Specialist, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role youll be reporting to the QC Equipment and Systems Senior Manager.
Essential Duties and Responsibilities Act as a lead for Equipment and System Introduction and Qualification within the team.
Ensure following Eudra Lex GMP guidelines and all applicable regulatory guidelines.
Manage QC Equipment Specialists.
Ownership of QC Equipment and Systems within QC.
Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
Lead and support system improvements, development of detailed specification and standard operating procedures.
Execute and support 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 within agreed timelines.
Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
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 ? 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 c GMP, 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 Wu Xi corporate core values.
Requirements: Technical Competencies Excellent computer skills MS Office (Word, Excel, Power Point).
A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
Computer System Validation experience would be ideal.
Excellent planning and organizational skills, prioritizing abilities and work efficiently.
Excellent communication and interpersonal skills.
Experience 4+ years experience working in a fast-paced environment.
Experience in a GMP facility, in a lead or project manage 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.
Behavioural Competencies Collaborative and inclusive approach to work and your colleagues.
Excellent problem solving and troubleshooting skills.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Apply now! Would you like to know more before you apply? Please visit us at or contact us via Wu Xi Biologics is an equal opportunities employer.
Skills: Computer Systems Validation Laboratory Instrumentation Qualification GMP Quality Control Benefits: Bonus Canteen Life Assurance Paid Holidays Parking Pension VHI