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QC Lead

Independent Search Solutions LtdGalway City

5 days ago

Job description

Package :

Full Time / Perm Role
50k – €55k+ (Basic) Negotiable
Annual Bonus (5%)
Pension
Life Assurance
Disability Benefits
Paid Annual Leave
Parking

Role :

Prepare and implement plans both long and short term for your area of responsibility in line with the company’s defined strategy and agreed financial targets.

Duties :

Maintain accreditation under ISO17025 :

Manage the Quality Management Systems and SOP’s for the laboratory ensuring the requirements of ISO 17025 are implemented, maintained and complied with

Management of Quality Control Laboratory work planning to ensure all samples are tested in a timely fashion

People & Stakeholder Management :

Schedule, co-ordinate and supervise all testing within the QC laboratory ensuring that all testing is carried out in a timely fashion to meet company objectives and relevant KPIs

Supervise and develop the core QC Lab team by mentoring, training, and supporting personnel development plans, including allocate daily tasks for all QC lab personnel, staff issues, allocation of holidays, delegation of extended working hours when required, and in conjunction with company management policy and requirements

Represent the QC laboratory with support of the Quality department in regulatory and customer audits and coordinate the timely close out of NC actions / recommendations identified from relevant audits

Develop, maintain, and ensure implementation of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files

Maintain GLP compliance in the QC laboratory

Oversee QC SOP’s updates, change controls, deviations, CAPA’s and Laboratory investigations.

Review and ensure application of relevant standards relating to product testing and laboratory compliance

Perform product / batch release following review and verification of test results to ensure product / batch compliance

Ensure publication of batch certs of analysis on the website when testing is complete, and results confirmed compliant

Co-ordinate and supervise laboratory investigations to ensure they are captured, documented, and actioned upon within a timely manner

Ensure the implementation of appropriate corrective and preventative actions as deemed necessary following Quality team review

Review and trend lab generated data to ensure continual improvement

Support the Quality Department with preparation for Laboratory Management Review and Quality Control meetings

Mediate between the testing personnel and all other departments

Perform and facilitate / lead internal audits, regulatory audits, supplier audits, and customer audits

Support management and completion of site audit schedule.

Lead communication with customers regarding technical queries

Support raw material and supplier performance reviews

Coordinate equipment calibration, maintenance and qualification to the predetermined schedule

Maintain lab consumables to ensure continuous supply and no impact on testing

Ensure competency and EQA testing-pH and WASP is performed

Arrange and support training, continual improvement and supervision of test personnel

Provide technical support to QA and Production functions and customers when requested

Advise, facilitate, and implement systems to ensure continuous improvement of processes and services

Ensure test method and equipment validations are completed on time

Experience :

3rd Level Qualification in Engineering / Science

5-8 Years of Experience in Regulated Manufacturing – Medical Device, Pharma, Biotechnology, Life Science

5-8 Years Plus in a QC Laboratory environment

2-5 Year Management, Supervisor experience

Working knowledge of ISO 17025 Working knowledge of IVDD 98 / 79 / EC and / or IVDR (EU) 2017 / 746

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Qc Lead • Galway City

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