QA Specialist

Job Title: QA Specialist

Position Overview:
We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit.

Responsibilities:
Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.

As a QA Specialist, your typical day may include:
• Supports GMP activities from operational through to laboratory support programs.
• Partners with other departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
• Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
• Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
• Key participant within the QA team in the execution of their duties.
• Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
• Domestic and international travel may be required.

Requirements:
You will have fulfilled the educational requirements for this role and have experience in a similar role within an FDA/EMEA regulated environment, with knowledge of FDA/EMEA regulatory requirements.

• Bachelor’s Degree in a scientific/technical discipline required.
• A minimum of 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Desirable:
• Advanced degree (MS, MBA, PhD) preferred
• Experience in C&Q, and Process validation
• Experience in direct interactions with regulatory agencies during site inspections.

What you’re great at:
• Excellent interpersonal skills.
• Ability to operate as part of a team is critical.
• Customer focused.
• Innovative.
• Excellent communication skills both written and verbal.
• Attention to detail.
• Good problem-solving skills.
• Results and performance driven.
• Adaptable and flexible.
• Integrity, trustworthiness and objectivity.