Senior QA Specialist

4 weeks ago

Dublin, Ireland Alexion Pharmaceuticals Full time

This is what you will do:

Responsible for delivery of quality assurance activities at Alexion’s Dublin location to ensure new products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements.

The Snr. Quality Assurance Specialist leads all aspects of the execution of the site QA activities in order to protect the safety, quality and efficacy of new product introductions, thereby ensuring the availability of accurate, 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 review supporting tech transfer for new products. In particular, this will involve partnering with major collaborators such as CQV, Operations, QC, Technical services, Engineering and Planning to optimize patient supply.

You will be responsible for:

Quality Oversight on new product introduction in Bulk Drug Substance facility and the Packaging. Operations.

Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to technical transfer of new product introductions. 

Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, CQV, Quality Control, Quality Assurance, Facilities, and others.

Review and approval of validation documents for equipment, software and equipment qualifications, and others. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.

Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents.

Review and Approve TRA’s, MSRs, SAP requests related to new products.

Support NMI process and ensure adherence to NMI procedures and processes.

Investigation and approval of deviations generated encountered during qualification/validation testing.

Participation in the project change control program and deviations for modifications to new and existing equipment.

Provide mentorship to project teams on Quality regulations for Validation strategy and approach.

Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk

Ensures schedules for review and approval of GMP documents are maintained to meet the needs of project achievements and timelines.

Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement .

Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.

Actively support audit readiness activities and regulatory agency and internal audits.

You will need to have:

A minimum of 3 years validated experience within the pharma industry or a related field.

Solid understanding of cGMP requirements for pharmaceutical manufacturing and/or packaging required.

Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.

Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. 

Excellent accuracy and attention to detail

Good knowledge of relevant computer packages e.g. Trackwise or similar

Planning and organizing skills are required to plan, complete and track commitments of Quality Assurance and to adjust to changing priorities.

High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.

Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

The individual in this position is encouraged to represent Alexion Pharmaceutical interests, objectives and policies in a responsible and professional manner.

We would prefer for you to have:

Third level qualification e.g. B.Sc. in science/pharmacy with a proven record in cGMP Quality environment; or equivalent combination of education and experience.

Date Posted

23-Apr-2024

Closing Date

13-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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