In this role you will develop, establish ,maintain and audit quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
- Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
- Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
- Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
- Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
- Provides training and collaborationto staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment,systems and processes.
- Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
- Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.
- Strong and identifiable quality systems experience in a medical devices or related environment.
- Significant experience managing the quality system in a software validation environment.
- Relevant academic qualifications.
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Working knowledge and application of business and technical concepts, procedures and practices and general knowledge of industry practices, techniques, and standards.
- Strong project management and organisational skills.
- First class communication skills.
Why Choose This Role & SL Controls
- An excellent salary and benefits package including pension and health cover and other benefits such as:
- Educational assistance
- Income protection scheme
- Wellness and health initiatives
- The opportunity to work with clients who are global leaders in their field
- A supportive environment committed to employee development and wellness
- The opportunity to work with and help develop and improve upon industry leading technology solutions
- A collaborative and open culture where you are valued and have the opportunity to contribute to company initiatives and growth
About SL Controls
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 16 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Dublin and Florida. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.