Job Opportunity

Job Opportunity

Manufacturing Documentation Specialist

Manufacturing Documentation Specialist

Ireland Posted 2024-04-24

Manufacturing Documentation Specialist

The Manufacturing Documentation Specialist supports routine manufacturing within the WuXi Biologics Manufacturing 6 & 7 sites, including documentation generation and the maintenance of documentation systems.

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, Asia, and Israel. 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 Manufacturing Documentation 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 will report into the Manufacturing Operations Lead.

Your Responsibilities

Essential duties and responsibilities of this role include and are not limited to:

Support the generation of Documentation including SOP and MBR generation.
Co-ordinate internal and external review and approval of documentation
Proactively progress documents to achieve schedule adherence and to site policies & compliance with cGMP’s.
Be a reliable point of contact for the manufacturing suite for clear and precise communication of the documentation process and current status of documents.
Assist in the preparation of reports/presentations as required.
To update and format documentation including SOPs, forms, logbooks, and label templates.
To co-ordinate processing of documents into and out of WuXi Documentation system.
Prepare label templates and print labels as required for finished product.
Assist in the preparation of reports/presentations as required for the suite.
A key player on the operations readiness team during start up, interfacing with the project to ensure the manufacturing facility will operate as per the user requirements.
Ensure highest Quality & Compliance standards.
Write/review manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
Track and trend relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of their manage.
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Education:

Diploma / degree qualification is desirable

Knowledge/Experience:

Minimum of 5 years’ experience working in a fast-paced environment.
Experience in a GMP facility, in a documentation role is desirable.
Experience with facility start-up projects (brown field or green field) is desirable.
Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage

Personal skills

Excellent computer skills MS Office (WORD, EXCEL, PowerPoint).
Excellent organizational skills, prioritizing abilities and work efficiently.
Capable of planning ahead to ensure any problems are resolved promptly and accurately.
Excellent communication and interpersonal skills.
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.
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 - don’t 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 https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com

WuXi Biologics is an equal opportunities employer.

Apply now