QA Compliance Specialist

QA Compliance Specialist

An opportunity has arisen for a QA Compliance Specialist within a Pharmaceutical Manufacturing Multinational based in the West of Ireland. The successful candidate will become a key member of the Quality Team and will provide quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.

Key Responsibilities:
• Leading / Assisting in investigations arising out of product
or manufacturing processes non-compliance.
• Review/Audit of completed Batch Records.
• Review of Manufacturing Logs as required.
• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
• Completion of Incoming Raw Material checks, including product status maintenance (as required).
• Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
• Administration of Quality Logs, e.g. QA Hold, Sample Request.
• Lead operations floor daily walk around of manufacturing areas.
• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
• Other support as deemed necessary

Qualifications and Experience:
Third level degree in a science, quality or engineering discipline.
A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
• Experience in aseptic processing gained within either a quality or operations role is highly desirable.
• A strong knowledge of regulatory requirements is required. Cognitive Skills
• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Requires proven problem-solving skills and the ability to adapt to
new requirements.

For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)