This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
As one of the hires in this ambitious project, the Document Controller will be essential in ensuring efficient and effective qualification, approval and operation of the new state-of-the-art facility and ensuring that the Processes are faithfully transferred into the facility.
Essential Duties and Responsibilities for this Document Controller role include, but are not limited to, the following:
- Support the design, construction and qualification of the new cell culture and purification installation at our clients site, through to technology transfer and commercialisation. Support establishment of the commercial process and routine manufacturing by:
- Supporting MS&T to bring documents through the review and approval process
- Supporting other members of the Process Engineering Team.
- Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Supporting deviation management.
- Supporting change control prioritisation and implementation.
- Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
This role requires an experienced individual with a minimum of a technical BSc and/or directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of document systems and current Good Manufacturing Practices.
A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of technical disciplines, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
- Experience of writing, reviewing and approving technical documents
- Experience of representing the Team, Function and Site on cross functional or governance Teams.
- Experience with biological molecules including technology transfer regulatory filing and commercial drug substance manufacturing of biologics is a plus.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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