Qc Lab Manager

Overall responsibility for all activities within the QC Laboratory, including Compliance, Stability Program, Raw material testing, and finished product testing and release.
Ensuring compliance with Regulatory, GMP, Health and Safety, Chanelle Procedures, specifications, and environmental standards while meeting customer requirements.
Location:
5 days onsite in our Loughrea QC Laboratory
As our QC Lab Manager, your key responsibilities will include:
Compliance:
Ensuring QC compliance activities are performed according to scheduled action plans, maintaining up-to-date documentation such as SOPs, COIs, ECPs, and others.
Taking necessary actions as per procedural requirements when deviations occur, and ensuring CAPAs are completed and closed.
Participating in internal and external audits.
Evaluating and acting on trends within the QC laboratory.
Laboratory:
Planning and completing testing to ensure timely release of raw materials, in-process samples, finished products, pilot batches, and validation samples.
Verifying data in accordance with data integrity and accuracy requirements.
Overseeing the QC stability program, managing it per site and customer requirements, investigating out-of-specification results, and taking necessary actions, including notifications to authorities and customers.
Supporting new product introductions by testing new materials and products as per project plans and protocols.
Collaborating with Production, Planning, and Shipping to prioritize releases.
Leading and motivating analysts to meet weekly/monthly targets and shipping deadlines.
Ensuring all testing complies with current EU and US regulatory requirements, with a focus on data integrity and timely review and approval of results, protocols, and reports.
Providing technical guidance during testing issues, equipment failures, calibration failures, out-of-spec results, or method issues.
Maintaining and calibrating laboratory equipment.
Managing standards and controlled substances per Chanelle procedures.
Investigating analytical errors or out-of-specification results thoroughly.
Operating within the laboratory's annual budget.
Safety:
Ensuring the QC laboratory is maintained safely and in compliance with safety standards.
Coordinating safety activities such as risk assessments and safety training with the EHS department.
Training:
Ensuring all QC staff are trained and competent.
Coordinating internal and external training to develop staff skills.
Skills & Competencies:
Strong leadership and people management skills.
Excellent organizational and time management skills.
Proficient IT and analytical techniques with relevant software knowledge.
Adherence to ALCOA+ principles.
Ability to build relationships and collaborate effectively.
Excellent verbal and written communication skills.
Strong analytical and problem-solving skills.
Methodical, systematic, and structured approach to work.
Proactive and responsible attitude.
Practical, action-oriented management style.
Qualifications & Experience:
Bachelor's degree in a science-based discipline.
10-15 years in a pharmaceutical environment, with at least 5 years in senior or management roles.
Experience working in a QC lab within a cGMP pharmaceutical setting; knowledge of EU GMP is essential.
This position is only open to candidates who already hold valid work authorization for the EU.
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