- Reference: GY43205
- Job Type: Permanent
- Location: Galway, Limerick, Limerick city
- Category: Science, Pharmaceutical & Food
The successful candidate will be part of a dynamic team in a fast-paced environment and will assist with the development of processes and systems that drive compliance to critical regulatory requirements. The ability to manage relationships, identify compliance issues and execute resolution in a highly autonomous manner is critical to this position.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Provide guidance and direction on Computer Validation matters.
• Promotes a GxP and Quality mindset at all levels.
• Creates and maintains a strong relationship with the leadership team and participates in all appropriate meetings and venues.
• Work with Validation Management to ensure appropriate execution of validation strategies and compliance with internal procedures.
• Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected.
• Manages staff as assigned to work with project teams on their quality deliverables.
• Ensures direct-report staff is appropriately resourced, supported and has the tools and direction to properly execute their function.
• Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into systems
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11, Annex 11, data integrity gaps.
• Coaches, develops and mentors direct reports.
• Ensures safety and operational standards.
Education and Experience:
• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 10+ years’ experience in the pharmaceutical/biotechnology industry (biotech preferred) within the fields of IT, Automation or Validation. A minimum of 5+ years in Validation is required.
• Prior experience in a managerial capacity, as well as technical experience in a relevant operations function.
• Experience with distributed control systems, programmable logic controllers, batch control system standards, software development methodologies, and automated system lifecycle support in the pharmaceutical industry.
• Experience with requirements analysis, system design, implementation and validation of manufacturing execution and batch control systems in 21 CFR Part 11/Annex 11 compliant GMP manufacturing environments in the pharmaceutical industry.
• Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5.
For a confidential discussion and more information on the role/company please contact Amy O’Neill on 091-706718 or email email@example.com
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