Quality (QA) Supervisor Compliance

At Grifols we believe that diversity adds value to our business our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

The Quality Compliance Supervisor will focus on the quality compliance aspects of Albumin Manufacturing both purification/formulation and aseptically filled product ensuring that deviations from defined procedures are appropriately handled within a GxP manner providing assurance of product quality and patient safety. Specifically the supervisor will be responsible for the teams scheduling in support of day-to-day manufacturing operations product release and general business requirements. Additionally have responsibility of the teams structure and professional development with coaching mentoring and acting as a subject expert in the compliance field to support.

The QA Compliance function will be a key stakeholder of all core manufacturing departments including the wider QA network manufacturing validation QC and supporting functions.

Understanding of industry compliance guidances notably EU GMP Annex 1 Sterile Manufacturing with knowledge of the ICH Q-series PDA ISO and the FDA Aseptic Guide will be essential to be successful in this role.

What will you be doing

General:

• Ensure the quality of the work is maintained and inspection-ready in accordance with internal and external cGxP requirements and expectation.
• Ensure adherence to GMP EU Annex 1 FDA and other applicable regulatory guidelines.
• Support the cross-function readiness for batch certification ensuring all documentation related to the team is finalised within a timely manner.
• Ensure the team is in compliance with all Training and Health & Safety requirements in accordance with company policy.
• Provide the teams performance status with regular interaction with the wider site departments as defined via tier/triage-structures.
• Establish inter-team and cross-team KPIs to ensure performance is measurable for the functions goals and objectives aligned with the companys strategic objectives.
• Support the teams organisational structuring and provide general direction to ensure the team is successful in handling day-to-day operations in alignment with the departmental directives.
• Ensure the team is adequately trained to cover the full scope of team responsibilities and develop training (internal and external) where appliable to ensure quality and technical competencies.
• Be the QA Compliance voice / point-of-contact for the team to ensure appropriate distribution of communication (given & received) focused on compliance-related subjects.
• Support resource management (capacity model & hiring process) for the Compliance function to aid departmental objectives and business requirements.
• Deputise for the other core QA functions and/or QA Manager as required.

Leadership and Managerial:

• Provide operational leadership to navigate the QA Compliance team including coaching mentoring performance management professional development and objective setting.
• Manage the teams routine activities ensuring they are scheduled performed and completed within agreed timeframes and in accordance with procedures and regulations. Activities are inclusive of:
• Deviation investigation and CAPA lifecycle management including impact analysis data integrity and overall quality robustness and effectiveness.
• Authoring reviewing and approving compliance-related documentation inclusive of Risk Assessments SOPs Training and Records as required.
• KPI monitoring specifically focused on Deviations CAPAs and Training.
• Periodic GEMBA and walk-through audits of the manufacturing facility inclusive of manufacturing areas and quality control laboratories.
• Internal inspection of QA QC Validation and Manufacturing.
• Foster a strong stakeholder collaboration with other core QA and MFG functions to ensure quality compliance standards are adhered to.
• Foster a LEAN attitude to create a pro-active continuous improvement culture within the team and support the facilitation of Quality Mindset throughout the facility.
• Provide feedback to the team to facilitate professional development and foster an open-door culture.
• Maintain organised physical and electronic GxP systems to support fast retrieval of information for possible inspection (archiving).
• Any other duties as required following consultation with the post holder.

Technical:

• Provide technical expertise specifically focused on regulations and guidances for sterile manufacture under terminally filtered (aseptic processing) conditions presented in the form of coaching mentoring and presentations for stakeholder understanding.
• Participate in risk assessments or strategic decision meetings and act as a QA Compliance SME to ensure either new or modified processes are appropriately documented and implemented under GMP conditions for aseptic manufacture

Who you will be

Essential

• Working experience within a Sterile Pharmaceutical GMP-regulated industry with a Quality function.
• Minimum 5 years experience in a pharmaceutical quality environment under EU GMP regulation
• Working experience with QMS processes both paper-based and electronic systems (e.g. Veeva Vault Trackwise etc.)
• Working experience with Deviations Investigations and CAPAs of all classifications (Minor Major Critical).
• Working experience of people management (stakeholder or direct).
• Demonstrate a problem-solving mindset and working ethic/culture to effectively lead the team.
• Demonstrate project management skillsets for effective handling of multiple high-priority tasks.
• Sound understanding of EU GMP aseptic manufacture notably Annex 1 Sterile Manufacture.
• Understanding of ICH Q9 and Q10 Quality Risk Management.
• Understanding and experience with an EU regulatory body with hands-on inspection experience.
• Excellent verbal and written communication in English.
• Proficiency in Microsoft software.

Desirable

• Understanding of Albumin manufacture Purification and Aseptic Filling in a bag presentation.
• Understanding and working experience of cleanroom classifications (Grade A B C & D) and associated controls in-situ utilizing RABS technology.
• Exposure to systems such as SAP KNEAT and LIMS.
• Working experience of people management of 2 persons.
• Verbal and written communication in Spanish and/or Catalan.
• Demonstrate a problem-solving mindset and working ethic/culture to effectively lead the team.
• Bachelor or Masters degree in Pharmaceutical Sciences or Administration

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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