QC Manager - Micro - Dun Laoghaire - Dublin


Location: Ireland

EUR 65,000 - 75,000

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19259

Consultant: Karen McHugh






Do you have 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry?

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.

 

QC Manager - Micro - Dun Laoghaire - Dublin

 

Employer

Our Client and the role will be based in their Dun Laoghaire plant.

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

 

Job Description

Overall responsibility for QC In process, Release and Stability testing and the associated test and laboratory documentation.

Ensure the laboratory is operated in a safe manner

Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP

Compliance with Standard Operating Procedures and Registered specifications.

Provide an effective and efficient QC service by supervising, developing and coaching the QC team.

Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.

Issue trend reports on investigations, non conformances and Environmental Monitoring and identify laboratory practices and procedures for further development/improvement.

Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.

Approval of SOP’s, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications.

Participate in regulatory agency inspections.

Plan and implement procedures and systems to maximise operating efficiency.

Manage and contribute to the achievements of department productivity and quality goals.

People Management

Supervision/Management of laboratory personnel and adjustments to schedules to maximise efficiencies and adequately support production and other departments.

Conduct performance appraisal reviews for laboratory colleagues and identify training requirements for further development of colleagues.

Monitor and assist staff with work progress utilising lean standard of work tools.


Requirements 

Bachelor’s degree in a science discipline.

5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Excellent written and verbal communication skills

Understanding/experience with Trackwise, Change Control Systems, Documentation management system and SAP

Knowledge of applicable Regulatory requirements

Experience with Regulatory inspections desirable

Experience leading cross-functional teams desirable

Experience working with teams and influencing decisions

Have relevant years of experience in a pharmaceutical/healthcare Laboratory or a related technical function preferably in an Aseptic or microbiologically controlled environment.

Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role.

Strong background in microbiology and aseptic manufactured is required.

Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.


Package

Health plan for self & dependents

excellent pension plan

Annual performance related bonus

28 days annual leave

Share options

 

Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

taglab


Apply For QC Manager - Micro - Dun Laoghaire - Dublin


Upload CV
.doc, .pdf, .txt, .rtf, .html Files Accepted
Karen at Jobcontax