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QC Compliance Lead

QC Compliance Lead (RTHCL) Rathdrum, Republic of Ireland

 

POSITION SUMMARY

The QC compliance Lead will report to the Site QC Lead and be responsible to lead and supervise the compliance function including  Qualification, Calibration and maintenance of QC equipment, Empower and QC equipment administration activities , QC data integrity , QC inspection readiness , Stability program, Environmental monitoring   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 compliance and technical 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.

 

The role will report the Site quality leader for Empower and all QC Equipment administration activities.

 

POSITION RESPONSIBILITIES

Key objectives of this position include:

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

  1. Ownership of Laboratory Systems as assigned which includes QC calibration and maintenance, QC equipment administration, Stability program, Reference standards, retention program and Environmental program.
  2. Driving Quality System improvements within the QC laboratories
  3. Continuous improvement / operational excellence activities including Laboratory 5S and Lean Labs program
  4. Laboratory Documentation review/ approval (including documentation RFT improvement),
  5. Collection, Capturing, Review and Approval of Data for CPV and APR's
  6. Ensuring Compliance of Laboratory Systems with current regulatory requirements
  7. Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples as required.
  8. Method transfers and validation activities.
  9. Leading the Laboratory Tier 1 / visual management system meetings.
  10. Ensuring that the laboratory is operated in a continuous compliant manner & all processes and procedures are followed.
  11. 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.
  12. Coach and mentor QC Analysts within their team, supporting their training and development
  13. Support the development of Quality goals and targets as part of the organisation’s strategic plan/roadmap.
  14. Support development of Quality Operations Budget including resource planning and ensure adherence to Laboratory Budget.
  15. Serve as a Quality Culture role model and instil a strong Quality and Compliance Culture within the QC Team.

 

ORGANIZATIONAL RELATIONSHIPS

This position will need to achieve results through collaborating with colleagues directly or indirectly including;

  • Quality Team – both QA and QC
  • Manufacturing operations leads and team
  • GMT on and offsite
  • Operational excellence team
  • Regulatory affairs offsite
  • GMP inspection /corporate inspection

 

The successful candidate will need to interact regularly with site Leadership, Global Manufacturing and Technology (GMT), and Operations to ensure site goals and objectives are met.   

All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.

All employees are expected to model inclusion behaviours.  Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.

 

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 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.

PHYSICAL POSITION REQUIREMENTS

  • This is Rathdrum, Ireland Site based position.
  • This position requires onsite presence to supervise a 24/7 operational laboratory therefore while occasional remote working may be possible, primarily this is a site-based position.

 

 

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