QA MFG Monitoring Supervisor

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POSITION SUMMARY:

Quality Assurance Manufacturing Monitoring Supervisor is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).This role offers a chance to work in a stateoftheart facility in an innovative biotechnology company with excellent career development opportunities and a clear and committed patient directly to the QA Manufacturing Manager of Grifols Worldwide Operations (GWWO).The position will be responsible for a team of QA Manufacturing Analysts and to complete and support activities within the Quality Department relating to Environmental Monitoring Personnel Qualification Contamination Control and Clean Utility Sampling to provide Quality support for the aseptic manufacturing operations in Grifols Worldwide Operations Ltd (GWWO).To act as delegate for activities performed by QA Manufacturing Manager.

What will you be doing:

Communication

• Work with Maintenance Manufacturing Quality Control and Validation Departments to ensure QA Manufacturing Monitoring activities are completed in compliance with all regulatory requirements and per schedule.
• Leadership and crossfunctional updates.
• Notify relevant parties of issues and sampling status to ensure compliance is maintained.
• Input and monitor QA Manufacturing Monitoring metrics and KPIs.
• Responsible for all tasks and resources including crossfunctional coordination required to complete sampling activities within regulated environment in the required timeframe.
• QA Manufacturing Monitoring Activities2.1 Supervision of QA Manufacturing Analyst team to carry out tasks.
• SME for Environmental Monitoring and Aseptic Monitoring activities in Grade A B C and D areas and to provide onthejob training for qualification of team members.
• Oversight of all monitoring activities relating to Clean Utilities Environmental Monitoring and Personnel Monitoring.
• Qualify in gowning and participate in Aseptic Process Simulation monitoring intervention for entry to Grade A area.
• Support the training.
• Liaise with equipment suppliers to source monitoring equipment and ensure appropriate qualifications/calibrations are completed in line with compendial and regulatory guidelines.
• Ensure QA Manufacturing Monitoring procedures are created/reviewed in line with compendial and regulatory guidelines.
• Participate in HACCP risk assessment for revision of Environmental Monitoring Sampling Plans.
• Ensure inspection plans are up to date on SAP system.
• Schedule sampling activities including release of inspection lots.
• Completion of monitoring and sampling activities ensure correct samples per inspection plan.
• Perform trending of Environmental Monitoring results prepare monthly report for and attend the Environmental Review Committee.
• Carry out technical review of data as required and support annual product quality reviews.
• Lead investigation of sampling activities where trends are identified and alert/action limits are reached or OOS reported for samples taken.
• Responsible for followup corrective actions identified through the Deviation system.
• Participate in and be responsible for QA Manufacturing Monitoringrelated CAPAs.
• Support the quality audit/inspection programmes.
• Support the change control system.
• Support projects and continuous improvement initiatives within the Quality Department and other functional areas.
• Flexibility and willingness to carry out shift work when required.
• Act as delegate for all activities performed by the QA Manufacturing Manager relating to QA Manufacturing Monitoring
• Any additional activities as assigned by the QA Manufacturing Manager.

Team Responsibilities

• Ensuring training and development of QA Manufacturing Analyst team members in conjunction with team development team goals and business needs.
• Responsible for team success by agreeing implementing and monitoring individual and team objectives and targets to ensure QA Manufacturing Monitoring tasks are completed whilst ensuring company policies and procedures are adhered to.
• Provide feedback to team members to facilitate development.
• Hiring new colleagues if system/schedule requirements drive demand.
• Ensure the QA Manufacturing Monitoring team adhere to safety standards to maintain a safe working environment.
• Develop improve and implement QA Manufacturing Monitoring procedures processes and systems.
• GMP implementation and sitewide Quality current knowledge of regulatory and industry standards trends and advancements through independent reading and training.

What youll bring

Essential experience and skills

• include strong knowledge of aseptic behaviors environmental and personnel monitoring
• rootcause investigations technical writing communication skills and proficiency with Microsoft Office and SAP.
• A minimum of 5 years of QA/QC experience and a scientific bachelors degree are required.
• Desirable skills include supervisory experience statistical analysis (e.g. Minitab) and knowledge of plasmaderived product manufacturing.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• 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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Location: Grange Castle International Business Park Grange Co. Dublin D22 K2R3

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