Specialist, QA Document Control - Ireland
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- Responsible for delivery of compliant documentation activities at the facility to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements.
- The QA Documentation Control Specialist executes the site documentation activities at our company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets.
- This key role must ensure effective interaction with other departments and locations regarding GMP Document preparation, review and issuing. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Site Services, Engineering and Planning to optimize patient supply.
- Responsible for the document control of all site cGXP documents.
- Control and maintain the onsite/off site documentation archive to maintain GMP compliance.
- Maintain procedures on site for document control.
- Issue and control master batch records, validation protocols and reports as required.
- Site administrator for electronic document control system.
- Deliver training to new starts on the electronic document control system.
- Coordinate the approval of SOPs on the document control system.
- Actively contributes to continuous improvement activities.
- Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives
- Assure that records are readily retrievable and in inspection-ready condition.
- A minimum of 3 years relevant experience within a similar or related field.
- Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
- Direct experience of GMP within a healthcare company is essential
- Excellent accuracy and attention to detail
- Good knowledge of relevant computer packages e.g. Documentum or similar, Trackwise and proficiency in Microsoft word, Visio, excel an advantage.
- Planning and organizing skills are required to plan, execute and track commitments of Documentation Control and to adjust to changing priorities.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
- The individual in this position is expected to represent our company interests, objectives and policies in a responsible and professional manner.
- National second-level qualification e.g. Leaving Certificate
- Third level qualification, e.g. B.Sc. in science or related area.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas