Position Summary 

The CQV Quality Assurance Specialist will oversee the commissioning and qualification activities for the warehouse and laboratory expansion projects at the Alexion Dublin Manufacturing Facility. This role also involves supporting validation activities related to existing processes, equipment, and systems, ensuring compliance with applicable regulatory and quality standards. This position requires providing quality oversight on the execution of established CQV lifecycle processes and protocols to ensure adherence to Good Manufacturing Practices (GMP) and other relevant standards. 

Responsibilities include reviewing and approving qualification protocols, reports, work orders, and other GMP documentation such as Risk Assessments and FMEA reports, supporting equipment and facility qualification, maintenance activities, and ensuring data integrity for computerized systems in accordance with regulations, SOPs, specifications, and other applicable acceptance criteria. 

The role involves supporting the qualification of analytical equipment in alignment with USP requirements and site procedures and standards. The CQV Quality Assurance Specialist will analyze testing results to determine their acceptability against pre-determined criteria. 

Additionally, the position supports investigations and troubleshooting efforts as part of a multi-functional team to develop solutions or recommendations for changes and improvements. This includes reviewing, editing, and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation. 

Principal Responsibilities 

• Support the development, review, and approval of commissioning and qualification documents, including plans, protocols, and reports.
• Ensure that documents comply with relevant regulatory requirements and internal procedures. 
• Participate in risk assessments related to equipment, systems, and processes to identify and mitigate potential risks. 
• Collaborate with cross-functional teams to implement risk mitigation strategies 
• Ensure all CQV activities are conducted in compliance with GMP, FDA, EMA, and other applicable regulatory standards. 
• Support the qualification of analytical instruments in accordance with regulatory expectations and USP . 
• Supervise and resolve deviations, manage changes (GEP and GMP), and ensure the implementations of CAPAs effectively. 
• Provide guidance to project teams on Quality regulations for Validation strategy and approach. 
• Perform 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 Commercial Operations groups. 

Qualifications 

• At least 5 years of relevant experience in the pharmaceutical industry in a similar or related role. 
• Strong understanding of GMP and validation principles. 
• Comprehensive knowledge of cGMPs, GLPs, GDPs, USP , and data integrity requirements.
• Excellent analytical and problem-solving abilities.
• Proficient documentation and communication skills.
• Familiarity with relevant software packages, such as KNEAT and VAULT Quality.
• Strong planning and organizational skills to manage Quality Assurance commitments and adapt to changing priorities.
• Skilled in technical writing.
• Excellent interpersonal skills, with the ability to communicate effectively both verbally and in writing.
• Expected to represent Alexion Pharmaceutical's interests, objectives, and policies in a responsible and professional manner. 

Education 

• Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.