This role is responsible for providing technical expertise and oversight for laboratory operations, ensuring compliance with relevant regulations and standards. You will oversee testing programs at the site supporting production activities and have the opportunity to play a key role in start-up and qualification projects.

Key Responsibilities:

• Managing testing programs to ensure compliance with regulatory and corporate requirements across laboratory operations.
• Providing technical leadership and guidance on the development of procedures, quality systems, method validations, equipment qualifications, and cross-functional lab support.
• Offering expertise in laboratory methods and techniques, with experience in analytical testing being an advantage.
• Leading verification of methods for new materials and products.
• Participating in cross-functional teams to ensure alignment across quality systems and practices.
• Overseeing data trending and reporting processes, and leading review meetings to evaluate quality trends.
• Ensuring compliance with standard procedures and registered specifications.
• Coaching and developing team members to meet objectives and support professional growth.
• Driving a culture of continuous improvement across laboratory operations.
• Experience with laboratory data systems (e.g., LIMS or similar platforms) would be an advantage.
• Acting as a subject matter expert for investigations, deviations, and change controls, identifying opportunities for process improvement.
• Staying current with regulatory and industry trends relevant to laboratory and production quality.
• Reviewing and approving technical documentation, including regulatory submissions and responses.
• Supporting and participating in audits (internal, external, and regulatory).
• Maintaining a strong safety and compliance culture in all testing activities.
• Building strong relationships within the local and global quality networks to support organizational goals and compliance.

Qualifications & Experience:

• A degree in a scientific, engineering, or related discipline is required.
• Experience in regulated industry laboratory operations, preferably in the pharmaceutical, biotechnology, or similar field.
• Strong knowledge of GMP, GLP, or relevant regulatory guidelines.
• Proven ability to plan and manage resources effectively in a dynamic environment.
• Excellent communication and interpersonal skills.
• Demonstrated experience in project leadership and decision-making.
• Experience in laboratory quality functions or regulated testing environments is preferred.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O’Mahony from Next Generation Recruitment using the apply button.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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