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Pharmaceutical quality assurance specialist

Galway
beBeeQualityControlManager
Quality assurance specialist
Posted: 23 August
Offer description

Job Opportunity

About the Position

Our organization is seeking a highly skilled Quality Control Laboratory Manager to oversee all activities within our laboratory.

The successful candidate will be responsible for ensuring compliance with regulatory requirements, GMP, Health and Safety, company procedures, and environmental standards while meeting customer requirements and needs.

About the Role

This is a 5-day onsite position in our laboratory.

As our QC Lab Manager, your key responsibilities will include:

* Compliance:
o Ensuring that quality control compliance activities are performed as per scheduled action plans.
o Ensuring that necessary actions are taken as per procedural requirements when deviations occur.
o Evaluating and taking action on trends within the laboratory.
* Laboratory:
o Ensuring planning and completion of testing to allow for timely release of raw materials, in-process samples, finished products, pilot batches, and validation-related samples.
o Oversight over the quality control stability program, ensuring that the program is managed as per site and customer requirements.
o Supporting the new product introduction process by ensuring new materials and products are tested as required.
o Collaborating with production, planning, and shipping to determine priorities for release.
* Safety:
o Ensuring that the laboratory is maintained in a safe and compliant manner to ensure personnel are performing their duties in a safe manner.
o Coordinating safety-related activities with the EHS department.
* Training:
o Ensuring that all staff in the quality control department are trained and competent to perform their duties.
o Coordinating with internal and external parties to arrange suitable training.

Qualifications and Experience

A bachelor's degree in a science-based discipline.

10-15 years of experience in a pharmaceutical environment, with at least 5 years in senior or people management positions.

Experience working within a quality control lab within a pharmaceutical cGMP environment, with knowledge of EU GMP essential.

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