Principal Scientist - Quality Control Compliance

Eli Lilly Benelux

Limerick, Ireland

The Senior Scientist Compliance role in Quality Control provides technical support for the compliance systems within the quality control laboratory. This role will be responsible for the interpretation of regulations; design, implementation, compliance and support of the laboratory quality systems associated with all testing activities within the QCL function.

Specifically, during the startup phase of the Limerick site (2024 to 2026) the senior scientist compliance will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.

Responsibilities:

Interpret regulatory requirements and global quality standards to develop and maintain local paper free, digital enabled systems, processes and procedures. Ensure internal and external compliance requirements including data integrity requirements are incorporated into the lab systems and processes;
Monitoring of GMP and compendial compliance;
Own the GMP readiness plan for the labs to ensure a consistent and compliant approach across all laboratories during start up;
Design, implement, maintain and own the analytical equipment lifecycle management process including oversight of third-party service providers providing support for equipment lifecycle activities. Review GMP documents associated with equipment qualification and calibration including DQ/IQ/OQ/PQ documents for analytical equipment and associated utilities;
Implement the QCL Training/Personnel Qualification Strategy for start-up and subsequent phases ensuring alignment with site policies and procedures;
Serve as QC SME for lab processes such as equipment qualification, lab investigations, personnel qualification etc.
Work with central functions in the development and delivery of standardised processes and procedures in QC;
Perform / support change controls, deviations and root cause investigations. RCI SME/ mentor for QC;
Identify and implement appropriate CAPAs;
Author/review key GMP documents such as GMP standard operating procedures, training materials, test methods, qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc.;
Process owner for lab specific GMP service providers;
Lead the QC inspection readiness program;
Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, and Food and Drug Administration;
Collate QC compliance metrics and make recommendations to management on actions;
Provide ongoing education, coaching, feedback and mentoring to QC personnel as it relates to execution of quality systems;
Serve as QC Quality risk management facilitator and SME.

Job specific pre-requisites:

Safety first approach to activities;
Proficient in English;
Technical expertise in analytical equipment lifecycle management, compendial requirements for lab equipment and testing;
Understanding of data integrity requirements in a QC environment;
Highly competent in the use of digital solutions for data, equipment and laboratory management;
Experience with regulatory inspections.

Basic Requirements:

Hons Degree Qualified – B.Sc. in Analytical Chemistry, Chemistry/Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience.

Additional Skills/Preferences:

Strong written and oral communication skills;
Excellent attention to detail;
Ability to work independently, self-sufficiently, and pro-actively in the performance of work duties;
Ability to influence others to implement changes in the minimum time;
High learning agility and flexibility to achieve the required outcomes;
Imaginative approach to problem solving and solution discovery.

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