QC Lead

My client is a Galway based facility which is INAB & HPRA Accredited in Microbiology Media Manufacturing.

 

They have a need to fill a Leadership position within the Quality Team – QC Lead.

 

I am keen to speak with Laboratory based Quality Managers coming from Regulated Manufacturing, who have track records of leading quality functions across facilities and a background in people management.

 

An excellent opportunity with career prospects at this large and diversified business – APPLY TODAY

 

Quality Control / QC Lead / QC / Quality Assurance / cGMP / ISO 17025 / Microbiology Media / Galway / Ireland

 

Job Title: Quality Control Lead

Location: Galway

Reporting To: QA Manager

Direct Reports: Quality Control Laboratory Staff (5)

Package:

• Full Time / Perm Role
• €50k (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

 

If you would like to be considered for this opportunity why not contact me directly on my mobile 00353 (0) 87 25 35 247, Just ask for Patrick.

 

Alternatively, follow the links below and send me your CV.

 

Key Words: Quality Control / QC Lead / QC / Quality Assurance / cGMP / ISO 17025 / Microbiology Media / Galway / Ireland

 

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