Quality Assurance (QA) Lead

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POSITION SUMMARY:

A QA Lead is required for the Albumin Filling Plant at key role is responsible for driving excellence in aseptic manufacturing through expert training coaching and oversight of cleanroom behaviours contamination control and sterile techniques. Acting as a Subject Matter Expert (SME) the QA Lead supports site-wide sterility assurance initiatives and ensures alignment with current regulatory standards including EU GMP Annex 1 (2023) Annex 15 and cGMP requirements.

The successful candidate will lead the design and execution of training programs media fills personnel qualification and contamination control strategies while maintaining a strong partnership with Quality Validation and Operations teams. The role also includes active participation in inspection readiness and continuous improvement initiatives contributing to both operational efficiency and regulatory compliance.

In addition the QA Lead will oversee environmental monitoring and sanitation efforts support audit and inspection preparedness and represent the site in aseptic governance forums. This position offers a high-impact opportunity to shape aseptic standards mentor operations personnel and influence the long-term success of sterile product manufacturing in a dynamic multi-product environment.

What will you be doing

General:

Act as a knowledgeable Subject Matter Expert (SME) for aseptic filling operations within the Albumin plant.
Provide cross-functional technical support and development to the aseptic filling operations team.
Mentor and develop supervisors to become SMEs in aseptic techniques and behaviours offering continued technical guidance.
Lead the site sterility assurance program including contamination control strategy (CCS) cleanroom design oversight aseptic process simulation (APS/media fills) and environmental monitoring (EM).
Offer expert input on sterile standards and guidelines including Annex 1 (2023) Annex 15 and the EU GMP Guide.
Ensure departmental objectives are achieved in alignment with company standards with a focus on compliance safety and reliability.
Design update and monitor training plans covering aseptic filling techniques and behaviours tracking individual progress.
Establish and maintain training programs based on current sterile standards regulatory guidelines and best practices.
Review and ensure aseptic filling documentation (e.g. SOPs OJTs) is accurate up to date and clearly written.
Participate in and support process simulation (media fill) activities.
Collaborate with Quality Validation and Operations teams to ensure successful execution of media fills.
Stay current with industry developments by attending relevant conferences (e.g. HPRA FDA) as required.
Promote a safe working environment by complying with all Environmental Health and Safety (EHS) regulations and procedures.
Generate reports and presentations as needed to support operational goals and project updates.
Maintain oversight and awareness of ongoing activities in your assigned area of responsibility.
Lead or support the execution of the personnel environmental monitoring (EM) plan for the filling department.
Analyse trends in personnel and environmental monitoring data and implement corrective actions to enhance compliance.
Provide both formal and informal feedback on the aseptic qualifications and performance of the operations team.
Contribute to cleanroom operations and contamination control ensuring adherence to current Good Manufacturing Practices (cGMP).
Provide support for inspection readiness including participation in health authority inspections inspector interactions and follow-up on observations.
Lead audit preparedness efforts ensuring facilities and equipment are inspection-ready and maintained to regulatory and corporate standards.
Contribute to the sites sterility assurance program by ensuring facility design equipment and processes align with aseptic standards.
Oversee and support sanitisation programs across the facility.
Assist in managing environmental monitoring (EM) and utilities programs along with aseptic and contamination control strategies in a multi-product environment.
Review and maintain site procedures related to gowning aseptic practices and contamination control.
Ensure full compliance with all EHS standards including the timely reporting of incidents and active contribution to a culture of continuous safety improvement.

Leadership and Managerial:

The role will also lead other aspects of operations if the business need arises

Deliver training in alignment with the sites sterility assurance program and quality initiatives.

Develop and implement comprehensive training and requalification programs for isolator activities gowning procedures for Grade C and D areas and aseptic behaviours.

Foster a culture of continuous improvement through constructive feedback and coaching on aseptic processes.

Assume leadership over other operational areas as required by evolving business needs.

Deliver hands-on training to new and current employees verifying their competency and qualification for aseptic operations.

Coach and support team members in their training and development to ensure they receive the appropriate qualifications.

Technical:

Maintain up-to-date knowledge of regulatory requirements and best practices relating to sterile product manufacturing facility design contamination control and data integrity.

Represent the site in aseptic governance bodies and cross-functional projects to ensure regulatory and global compliance in aseptic processing and sterile product filling.

Support and lead investigations affecting safety quality or compliance; ensure timely implementation of effective CAPAs.

What you will bring

Essential

• Strong knowledge of sterile manufacturing processes aseptic techniques and contamination control
• Deep understanding of regulatory compliance within cGMP manufacturing including EudraLex Volume 4 Annex 1 and EU GMP guidelines
• Knowledge of filling and aseptic practices sterilisation techniques GMP regulations and quality operations
• Proficient in environmental and personnel monitoring programs and trend analysis
• Demonstrated leadership skills with the ability to motivate guide train coach and develop individuals and teams
• Ability to coach mentor and cross-train colleagues within core technical areas
• Strong decision-making skills with the confidence to challenge respectfully and professionally
• Excellent verbal and written communication skills with strong technical writing ability
• Proactive and collaborative approach; works effectively with cross-functional teams such as Manufacturing Validation Engineering and Quality
• Strong interpersonal skills; capable of maintaining productive relationships across departments and levels.

Desirable

Facility start-up experience.
Willingness to travel domestically and internationally as needed.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee (Irish Life)
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities- Social activities eg. Padel Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply were excited to hear from you

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