QA Graduate
Posted 6 hours 45 minutes ago by 450 Eli Lilly Kinsale Limited
Location: Dundurrow, Kinsale
Working Model: Onsite, 5 days per week
Programme Duration: 24 months
Salary: €49,000 to €53,500
Mobility Requirement: Candidates must be open to opportunities at US and OUS sites following completion of the Graduate Programme.
About the Role We are seeking a recent MSc or PhD graduate in Science, Engineering, or a related discipline to join our Quality Assurance Graduate Programme. This 24-month programme provides an opportunity to develop practical experience within a regulated manufacturing environment, building strong knowledge of Quality Assurance, GMP requirements, manufacturing processes and quality systems. As a QA Graduate, you will work closely with manufacturing and cross functional teams, gaining hands on experience while helping to ensure that products, processes and systems meet the required quality and regulatory standards.
Key Responsibilities- Provide Quality direction and governance within your assigned area of responsibility.
- Support and manage quality related matters within the manufacturing environment.
- Review and approve relevant Quality and GMP documentation, ensuring requirements are met.
- Perform day to day activities in compliance with site policies and procedures.
- Promote safe working practices and promptly report any safety concerns.
- Support the establishment, maintenance and continual improvement of Quality Systems.
- Develop a strong understanding of the manufacturing process, including facilities, procedures, people and Quality Systems.
- Help ensure consistent implementation of Quality standards across assigned areas.
- Support ongoing GMP compliance and ensure Quality Systems and programmes remain in a validated state and aligned with regulatory commitments.
- Maintain a regular presence within manufacturing areas to monitor GMP compliance, programmes and systems.
- Participate in production floor audits and the site self inspection programme.
- Verify the effective implementation of key GMP programmes.
- Review and approve key GMP documents.
- Escalate critical Quality issues to the appropriate level of Quality management.
- Communicate and provide guidance to colleagues on GMP requirements and regulations.
- Support the development and delivery of training associated with assigned Quality Systems and Quality programmes.
- Provide coaching and support to Operations personnel and other QA colleagues on appropriate risk management and timely, business focused solutions to compliance issues.
- Contribute to the site's overall GMP plan and Quality objectives.
- Assessing the potential impact of deviations on product quality.
- Reviewing and approving change controls, deviations and failure investigations.
- Reviewing suspect analytical results, product quality complaints, stability studies and associated reports.
- Reviewing documentation associated with manufactured batches.
- Reviewing and approving GMP documentation associated with qualification and validation.
- Reviewing raw material specifications, sampling protocols, master formulas and process flow documentation.
- Working directly with manufacturing teams to provide Quality oversight and support effective decision making.
- A recent MSc or PhD in Science, Engineering or a related discipline.
- Strong learning agility, curiosity and a willingness to develop within a regulated manufacturing environment.
- Excellent written and verbal communication skills.
- Strong organisational, prioritisation and self management skills.
- An ability to identify problems, assess risk and contribute to practical solutions.
- A collaborative approach and the ability to build effective relationships across different teams and functions.
- Confidence in positively influencing others and contributing to effective team decision making.
- Flexibility and the ability to work effectively in an environment where priorities can change.
- Chemical, peptide or protein synthesis.
- Development or implementation of digital solutions.
- GMP or regulated manufacturing environments.
- Quality Systems or Quality Assurance.
- Innovative problem solving and solution development.
- Demonstrate a high level of proficiency within your area of responsibility.
- Perform key Quality activities independently.
- Make sound Quality decisions aligned with business standards, GMP requirements and regulatory expectations.
- Effectively monitor GMP compliance, programmes and Quality Systems.
- Clearly communicate and educate colleagues on GMP requirements and regulations.
- Provide confident Quality oversight and support within a manufacturing environment.
- Apply appropriate risk management principles when addressing Quality and compliance issues.
- Be ready to support business needs and potential opportunities at US or OUS sites following completion of the programme.
- Business Awareness: Takes ownership of work, delivers to a high standard and proactively looks for better and simpler ways of working.
- Demonstrates strong organisation, prioritisation and self management.
- Learning Agility and Curiosity: Learns quickly, remains flexible and is comfortable working through ambiguity.
- Can identify and prioritise problems and contribute to effective solutions.
- Positive Influence: Addresses issues constructively, follows through on commitments and actively seeks feedback to improve performance.
- Relationship Building: Builds and maintains effective working relationships across different levels, teams and functions.
- Influencing Skills: Communicates confidently and can positively influence peers, stakeholders and cross functional teams to support good Quality and business decisions.
- Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is € - € Full time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).
Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!