We are seeking an experienced, motivated Facilities supervisor with excellent people management skills to supervise our team of facilities technicians located on our biopharma client site in Limerick. Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application. Key Qualifications * 5+ years of hands-on experience working in a regulated multi-facility environment * Proficient in Microsoft Office products * Strong people management experience with ability to motivate, mentor, and manage a diverse team * Must have the ability to learn quickly, work autonomously, and address any issues that arise * Demonstrated ability to plan and prioritize tasks in a self-directed work environment and maintain high levels of productivity without direct supervision * Analytical and organizational skills with the ability to supervise multiple high priority demands simultaneously * Communicate effectively and provide direction to contractors and vendors performing services for the company Description As a Facilities Services Supervisor, you will be responsible for overseeing the day-to-day tasks of Headcount Solutions facilities group, supervising a team of facilities staff, and ensuring a safe, clean, and efficient environment. Responsibilities will also include ensuring team compliance with agreed SLA’s and important metrics. Drive and support professional growth for team members, providing coaching and mentoring on areas for development. Select, develop, and evaluate personnel and vendor support, to ensure the efficient operations of all facilities services. xsokbrc Provide training to new team members manage traing matrix. Education & Experience Third level or trades background, along with 3 years maintenance/construction supervisory experience within a regulated environment
QA – CSQ/CQV Specialist Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. We are actively seeking to recruit a CSQ/CQV to become a key member of the Quality Team of a leading Pharmaceutical Multinational. The successful candidate will provide QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the site supporting the transition from project phase through to sustaining phase with respect to validation activities Responsibilities * Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes. * Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria. * Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements. * Review SOPs relating to qualification/validation activities. * Provision of support in Regulatory inspections and Client audits. * Provision of QA Validations expertise to maintain validation status of the facility. * Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes. * Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables. * Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training. Education background/ Experience * B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering). * Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment. * Thorough understanding of the validation requirements associated with a cGMP manufacturing facility * Strong technical aptitude is required. xsokbrc * Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE. * Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc
CQV Planner If you want to know about the requirements for this role, read on for all the relevant information. Role Supporting and Reporting into the Engineering Lead Responsibilities * 8+Yrs experience, * Extensive experience working within pharmaceutical manufacturing environment, * Experience Planning, executing, and delivering projects successfully, * Able to review and interpret engineering drawings and technical documentation, * Comprehensive knowledge of project controls, contract management, and contractor coordination, including tender programmes, contractual milestones, and extension-of-time evaluations, * Lead and run collaborative planning and coordination workshops, * Advanced user of Primavera P6 & Microsoft Project proficient, * Practical experience integrating xsokbrc with Last Planner scheduling systems, * In-depth understanding of design deliverables and subcontractor mobilisation processes. For full job description and immediate consideration please provide a CV and a member of our team will get in touch
Quality Specialist – Hybrid Role Make sure to apply with all the requested information, as laid out in the job overview below. We are currently seeking to recruit a Quality Specialist for a leading Pharmaceutical Manufacturer within the Munster region. The successful candidate will become a key member of the Global Development Team supporting all related QA activities. Responsibilities * Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification. * Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review. * Support product recalls and stock recoveries as appropriate. * Identify compliance gaps and make recommendations for continuous improvement * Creates and maintains assigned SOPs. * Perform and review complaints and deviation investigations, change controls and CAPA’s. * Compiles data for reports and presentations - May interpret data and draw conclusions. * Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance to SOPs, GMPs and applicable regulations. xsokbrc Qualifications and Experience * Degree in an Engineering or Science discipline. * Significant experience within the pharmaceutical industry * Strong communication skills both written and oral For more information and a full job spec please forward your CV in the strictest confidence to (email address removed)
