QC manager required to join a global pharma company based in Dublin.
- Supervise daily laboratory operations, ensuring laboratory personnel execute their responsibilities in strict accordance with relevant regulatory guidelines.
- Support the weekly and daily production schedules and where required participate in the daily pre-production meetings to review shift production goals and daily post-production meetings to review execution against the shift's goals.
- Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counselling, building and executing development plans, and providing career counselling for career progression.
- Provide direction to laboratory personnel internally and at contract laboratories to ensure production is able to complete the targets specified in the daily production plan.
- Manage samples for analytical testing and the generation of results at external /contract laboratories
- Ensure proper coverage in the laboratory by trained, skilled chemists.
- Ensure that laboratory personnel properly follow procedures and submit required documentation completely, accurately and timely according to current cGMPs.
- Ensure data reports on own team's performance are current, accurate, and distributed according to defined procedures.
- Maintain metrics for laboratory calibration, maintenance and utilization of instrumentation and equipment.
- Contribute to the continual improvement of all laboratory documentation to ensure they are current, accurate, and clearly define process and role responsibilities.
- Schedule and/or deliver training to laboratory personnel to ensure staff has the requisite skills to perform their work correctly, safely, and compliantly.
- Enforce cGMP, safety, housekeeping, and security procedures in the laboratory, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.
- Provide hands on training, support, and coaching to laboratory personnel and make timely decisions to ensure that performance Service Level Agreements (SLAs) can be met.
- Maintain accountability for own team's performance metrics that support the annual operating plan and site strategic plan objectives.
- Seek process innovation and continuous process improvement in laboratory area.
- Develop, execute, and evaluate scientific studies to improve the performance of current analytical methods.
- Lead the development and qualification of methods and sampling techniques for use in cleaning validation studies to support the site product mix.
- Assess new laboratory equipment purchases for laboratory effectiveness, efficiency and compliance.
- Provide guidance and training to QC Staff members on various GMP related activities.
- Provide timely status reports to laboratory management on the status and effectiveness of the laboratory Installation, Qualification, calibration and maintenance programs.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Sets a personal example that reinforces the company culture, reputation and standards.
- Prepare and conduct performance appraisals in accordance with Company guidelines.
- Lead department initiatives and projects.
Qualifications and Experience:
- Bachelor's Degree or above in Chemistry or related Science
- Extensive relevant Quality Control experience.
- Proven direct supervisory experience
- Demonstrated success in supervising a team, preferably in a pharmaceutical laboratory environment
- Experienced in aligning individuals and teams to business objectives
- Exposure to Lean manufacturing concepts
- Experience in managing by metrics
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.