QC Manager

Zoetis

Rathdrum, Ireland

The QC Manager will report to the Site QC Lead and be responsible to supervise and lead the Laboratory release function including Raw Materials, Intermediates, DPI and API’s (including the stability program) and In Process Control and provide core technical support in areas of chromatography, investigations/deviations, troubleshooting, instrument calibration/qualification, and regulatory requirements.

Their role is to provide a strong degree of technical and compliance leadership within the QC function as well as driving Quality System improvements and operational efficiencies within the lab and representing the Quality Department at meetings both on and offsite.

They will also be involved in the training, coaching and development of QC Analysts and have input to performance review and assessment.

POSITION RESPONSIBILITIES

Key objectives of this position include:

Leading their Functional Area in the Laboratory, providing direction, Leadership and Support in the following activities.

Laboratory investigations/deviations Chromatography & general Analytical troubleshooting.
Laboratory Documentation review (including documentation RFT improvement), Planning and Scheduling of Laboratory Testing Activities, Equipment qualification/calibration oversight, Ensuring Compliance of Laboratory Systems with current regulatory requirements.
Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples Collection, Review and Approval of Data for CPV and APR's Continuous improvement/operational excellence activities including Laboratory 5S and Lean Labs program Method transfers and validation activities.
Leading the Laboratory Tier 1/visual management system meetings.
Ensuring that the laboratory is operated in a continuous compliant manner & all processes and procedures are followed.
Driving Quality System improvements within the QC laboratories Ownership of Laboratory Systems as assigned Review and approval (as applicable) ensuring the accuracy, completeness and compliance of:
- Analytical and associated data generated within the laboratory;
- procedures (e.g. SOP's, EOP's, Training modules etc.) and Master Analytical Records;
- compendial changes; analytical Change Authorization packages;
- static data on ZLIMS;
- Safe Work permits etc.
Coach and mentor QC Analysts within their team, supporting their training and development Support the development of Quality goals and targets as part of the organisation’s strategic plan/roadmap.
Support development of Quality Operations Budget including resource planning and ensure adherence to Laboratory Budget.
Serve as a Quality Culture role model and instill a strong Quality and Compliance Culture within the QC Team.

EDUCATION AND EXPERIENCE

Bachelor of Science in Chemistry with 5-10 years of proven quality control and analytical laboratory experience with at least 2 years supervisory experience preferred, and with a demonstrated track record in the management of a modern analytical/microbiology laboratory operating in a GMP environment.
Familiarity with specialized areas such as analytical instrumentation, automated laboratory systems, validation and current regulatory expectations.
Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) preferred.

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

Ability to provide strong technical and people-based leadership and to work effectively in a team environment with ability to develop and adhere to self-directed standard work.
Excellent written and communication skills, as well as experience with presenting to leadership teams.
Flexible, adaptable and receptive to new and innovative ideas.
Sets Clear Direction and Aligns Team and Others Around Common Objectives.
In depth knowledge of regulatory standards (both existing and emerging) relevant to the laboratory.
In depth knowledge of procedures and work practices relevant to the operation of a Laboratory and associated IT Tools.
Experience with water system validation, environmental monitoring standards and process validation.
Demonstrated problem-solving skills.
Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives.
Drives for Superior Results and Passion to Win with demonstrated record in getting things done.
Demonstrated ability to work with internal and external colleagues and ability to collaborate effectively with others.

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