The Role – your day to day:
- Leadership activities including development, coaching and day to day management. Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to
complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
- Drive an understanding of the importance of compliance, considering an impact on GMP and
compliance and decisions made. Accountable for compliance via documentation completion, risk
assessments, review of protocols and reports, closing out preventative and corrective action,
participate in audits and inspections and proactively highlighting any issues around compliance.
- Ensure effective execution of cycle development for cleaning and/or sterilization/decontamination
processes, ensuring industry best standards and advances.
- Ensure effective execution of equipment/CTU validation programs, using Lean Six Sigma
methodologies to ensure continuous improvement. Actively drive and participate in heat
penetration/distribution studies associated with cycle development and PQ using Kaye thermal
system and biological challenges.
- Collaborate with multiple partners (third parties, vendors, quality, project managers, donor sites, operations and validation) in achieving excellence in validation programmes.
- Manage and support the execution of cleaning validation and validation programs i.e. Container
Closure Integrity (CCI), Extractable Leachable & Compatibility (EL&C), filter shipping and PPQ.
- Develop, implement and ensure effective execution of the Site re-qualification program. Manage
and perform data analysis and determine conclusions reached; facilitating others to do so; make
informed decisions/recommendations around conclusions reached from data analysis, using Lean
Six Sigma methodologies as appropriate.
- Drive compliance with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Work collaboratively to lead a safe and compliant culture.
- May be required to perform other duties as assigned.
The Essentials – what you need
- Typical Minimum Education
- Bachelors’ Degree or higher preferred; ideally in a Science, Engineering or another Technical discipline
- Significant experience in a comparable role; would typically have experience leading and
setting direction for a department and adding significant value to the business; ideally in a
pharma environment, preferably GMP biopharma setting
- Equipment and process validation
- Sterile filling processes and equipment
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Proficiency in Microsoft Office and job-related computer applications required
- Lean Six Sigma Methodology experience desired
- Focus on Customers and Patients
- Make Rapid, Disciplined Decisions
- Drive Results
- Build Talent
- Demonstrate Ethics and Integrity
For a confidential discussion and more information on the role, please contact Edel on 021 4911065 or email firstname.lastname@example.org
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