Job Type: Perm
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 email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Manager - Micro - Dun Laoghaire - Dublin
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.
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.
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.
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.
Health plan for self & dependents
excellent pension plan
Annual performance related bonus
28 days annual leave
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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