Our client, a leading speciality healthcare company, is looking for an experienced QA Specialist to join their state-of-the-art API manufacturing facility in Wicklow. This innovative organisation has approximately 10,000 employees globally, with a generated revenue of $6.3 billion in 2019. This is a brand new role due to ramp up of R&D and production.

The QA Specialist will have responsibility for ensuring that the process for the manufacture of API product is in compliance with cGMP and the associated regulatory requirements.

The Role

Duties and responsibilities of the QA Specialist will include:

• Evaluation, Approval & Monitoring of vendors including Quality Agreements (End to End Supplier Approval and Management).
• Provide QA support to Operations in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures.
• Provide QA support for Deviations, CAPA's, Change Control, Cleaning Validation and Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
• Review /Approve Master Batch Record (MBR), Review Batch Records / Review Cleaning Records as per the site procedures.
• Perform/Lead Internal Audits/Quality Walkthroughs.
• Quality Oversight of Warehouse and GMP Service Providers.
• Manage Vendor audits from planning to close out.
• Support continuous improvement initiatives, ensuring quality is built in and all corporate and regulatory requirements are met.
• Serving as a quality culture role model and instil a strong quality and compliance culture across the site.
• Active participation in site Tier meetings.

The Person

You will have skills and experience in the following:

• Undergraduate degree in pharmaceutical, biological or chemical sciences
• 5+ years of relevant industry experience, with current knowledge of cGMP's and regulatory guidance required
• Significant experience in QA supplier management and ISO 9001 and or Regulatory Affairs is desirable
• Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles
• Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
• Strong written and oral communication skills and ability to collaborate effectively with others
• Strong interpersonal, leadership and influencing skills, communication and motivation

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.