QC Analyst

About the Company

An exciting Pharma manufacturing site in Tipperary needs an experienced QC Analyst.

Working in a supportive and collaborative environment you'll benefit from a competitive salary and there are great progression opportunities

About the Position

Key Responsibilities

• Technical Laboratory SME with experience representing company in regulatory audits (i.e. front room experience responding to FDA / HPRA audit queries)
• Detailed understanding of Inhalation product testing requirements.
• Supports Laboratory Set-up activities
• Prepares Laboratory procedures, specifications, protocols & reports as required
• Performs Laboratory testing and investigations per SOP, applicable regulations and cGMP
• Performs peer review of documentation as required
• Performs Analytical method verification, validation and technical transfer as required
• Supports Laboratory/Site EHS governance
• Performs management of Laboratory consumables ordering and tracking
• Assists in Equipment Qualification activities, ordering and tracking as required
• Supports preparation for regulatory audits/visits and ongoing audit readiness
• Supports development of QC Testing processes
• Liaises with CROs and audits where appropriate

Experience/Requirements

• Degree in Chemistry or similar.
• 3-5 years of GMP laboratory experience
• EU Passport/ Irish Work permit.

Remuneration Package

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