Job Title: QA Operations Specialist (Shift Role) Location: Dunboyne, Ireland Work Type: On-site, Shift Role Overview A leading biopharmaceutical manufacturing facility in Dunboyne is seeking a QA Operations Specialist to support Quality Assurance activities within a GMP-regulated environment. The successful candidate will play a key role in ensuring compliance with cGMP regulations , supporting manufacturing operations, and maintaining high-quality standards across site processes. Key Responsibilities Release incoming materials and outsourced products in compliance with quality procedures, regulatory guidelines, and market authorizations. Liaise daily with cross-functional teams to address compliance issues in a timely manner. Participate in investigations, risk assessments, and resolution of deviations, complaints, and change controls . Perform QA review and approval of Change Controls, Deviations, CAPAs, SOPs, and related documentation to ensure GMP compliance. Provide QA oversight for qualification/validation activities, technical transfers, laboratory operations, and commercial manufacturing . Support training development and deliver SME guidance on QA procedures and SOPs. Maintain strong documentation practices aligned with GMP requirements. Support continuous improvement initiatives to enhance quality and operational efficiency. Participate in risk management activities and escalate compliance risks to management when required. Provide real-time operational support during manufacturing activities. Participate in site walk-throughs / GEMBA processes . Support contamination control strategies to ensure product quality and regulatory compliance. Qualifications & Experience Degree in Science, Quality, Engineering, or a related technical discipline . 4–7 years’ experience in QA, QC, or Technical Operations within the biopharmaceutical or pharmaceutical industry . Strong understanding of GMP regulations and quality systems . Experience in investigations, risk management, and problem-solving as a Quality SME . Familiarity with PAS-X, SAP, and Veeva systems is desirable. Knowledge of regulatory requirements from authorities such as FDA, HPRA, and EMA . Experience supporting or interacting with regulatory inspections is advantageous. Strong communication, organizational, and documentation skills. Ability to work both independently and collaboratively in a fast-paced GMP environment. Additional Information Candidates must be available to work flexible shifts and be on-site full time . Previous QA Operations or manufacturing support experience is highly desirable. #J-18808-Ljbffr
Associate Quality Specialist – Contract-Fixed term Pay rate- €22 to 35/hr Location- Ballydine Fully Onsite Overview An excellent opportunity has arisen for an Associate Quality Specialist to support daily Quality Assurance activities within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will work as part of a cross-functional Integrated Process Team (IPT), ensuring compliance, quality oversight, continuous improvement, and right‑first‑time manufacturing operations. Key Responsibilities Participate as the QA representative within cross‑functional production support teams to ensure compliant and efficient manufacturing operations. Review and approve batch records, cleaning documentation, testing records, and associated GMP documentation. Ensure laboratory Out of Specification (OOS) results, deviations, and quality events are appropriately documented, investigated, and closed with effective CAPA actions. Support deviation investigations, root cause analysis, and process performance monitoring activities. Trend deviations and quality events to identify recurring issues and continuous improvement opportunities. Provide guidance on GMP quality requirements, validation maintenance, and participation in risk assessments. Support change control activities, ensuring changes are properly assessed, documented, and completed. Prepare and support Annual Product Reviews (APR) and Annual System Reviews. Participate in internal audits, GMP walkdowns, and inspection readiness activities. Support the generation and communication of quality metrics and KPI reporting. Create, review, revise, and approve SOPs and quality procedures as required. Collaborate with production, laboratory, engineering, and quality teams to support compliant manufacturing operations. Required Competencies Communication Strong verbal and written communication skills with the ability to communicate effectively across departments. Teamwork Ability to work collaboratively within cross‑functional teams in a fast‑paced GMP environment. Decision Making Strong analytical and problem‑solving skills with the ability to make sound quality‑based decisions. Adaptability Ability to adapt to changing priorities, business needs, and manufacturing schedules. Attention to Detail High level of accuracy and attention to detail in documentation review and compliance activities. Motivation Self‑motivated, proactive, and committed to continuous improvement and operational excellence. Skills & Experience Required Degree or postgraduate qualification in Science, Pharmacy, Chemistry, Biotechnology, or related discipline. Experience working within a GMP-regulated pharmaceutical or biopharmaceutical environment. Knowledge of quality systems and electronic systems such as SAP, TrackWise, or similar platforms is desirable. Experience supporting deviation investigations, CAPA, change controls, and GMP documentation activities. Understanding of validation lifecycle and GMP compliance requirements. Knowledge of Lean Manufacturing and Continuous Improvement principles is advantageous. Experience with electronic or paperless manufacturing systems is beneficial. Experience in high‑potency manufacturing or spray drying operations would be considered an advantage. #J-18808-Ljbffr
Independent Solutions is looking for a QA Operations Specialist (Shift Role) to ensure compliance with cGMP regulations at their biopharmaceutical manufacturing facility in Dunboyne, Ireland. The successful candidate will be responsible for quality assurance activities, supporting manufacturing operations, and maintaining high-quality standards. A degree in Science or related field, along with 4–7 years of QA or QC experience, is required. The role necessitates flexibility with shifts and demands strong communication and problem-solving skills. #J-18808-Ljbffr
Independent Solutions in Leinster, Ireland is looking for a Validation Engineer to support validation activities in a pharmaceutical manufacturing facility focused on innovative vaccine development. This role requires 5 years of validation experience within GMP-regulated environments and a strong understanding of regulatory requirements. Responsibilities include supporting site validation activities, assisting with EMPQ strategies, and ensuring compliance with GMP standards. Flexible working arrangements may be considered based on business needs. #J-18808-Ljbffr
An excellent opportunity has arisen for a Validation Engineer to support validation activities within a state-of-the-art pharmaceutical manufacturing facility focused on innovative vaccine manufacturing and product development. This role is ideal for candidates with broad validation experience across equipment, utilities, and facilities within GMP-regulated pharmaceutical or biotechnology environments. Key Responsibilities Support site validation activities across multiple workstreams. Assist with Environmental Monitoring Performance Qualification (EMPQ) strategies and maintenance of EM protocols/procedures for graded pharmaceutical areas. Support equipment qualification activities from Operational Qualification (OQ) through Process Performance Qualification (PPQ), including requalification/revalidation activities. Assist with regulatory submissions, audits, inspections, and site readiness activities. Participate in problem-solving and risk assessment initiatives. Drive continuous improvement and operational excellence activities. Support organizational initiatives related to safety, compliance, forecasting, and standardization. Maintain strong focus on GMP compliance, quality standards, and patient safety. Stay updated with scientific, technical, and regulatory developments. Requirements 5 years’ experience within pharmaceutical or biotechnology validation environments Strong understanding of cGMP and regulatory requirements Biological Sciences Chemical Engineering Biological Engineering or related discipline Preferred Experience Facility, utility, and equipment qualification including: CTUs Parts Washers Autoclaves Clean Utilities HVAC/Cleanrooms Experience supporting: Upstream/downstream processes Fill finish/formulation operations Technology transfer Process validation & PPQ Commercial manufacturing readiness Regulatory documentation/CTD authoring Additional Information This is a general validation engineering role with broad exposure across validation activities. Candidates do not need to be specialists in one particular validation area. Flexible/hybrid working may be considered depending on business needs. #J-18808-Ljbffr
We are currently seeking a QC Micro Technician to join a GMP-regulated Quality Control Microbiology laboratory supporting pharmaceutical and biopharmaceutical manufacturing operations. This role is ideal for candidates with experience in microbiology testing, GMP laboratory practices, and aseptic techniques within regulated manufacturing environments. The successful candidate will support routine microbiological testing, environmental monitoring activities, and laboratory compliance while ensuring adherence to GMP, GLP, and EHS standards. This role operates on a shift-based schedule. Key Responsibilities Perform microbiological laboratory testing in accordance with GMP and GLP requirements. Conduct bioburden testing, environmental monitoring, WFI sampling, plate enumeration, endotoxin testing, and sample management activities. Ensure compliance with ALCOA+ data integrity principles for all laboratory records and documentation. Maintain laboratory readiness, cleanliness, calibration status, and compliance within QC microbiology areas. Support deviation investigations, non-conformance reporting, CAPA activities, and laboratory documentation reviews. Prepare, review, and update SOPs, training materials, logbooks, and laboratory procedures. Follow aseptic techniques, PPE requirements, contamination control procedures, and EHS guidelines at all times. Collaborate with Quality, Manufacturing, and Engineering teams to support operational and compliance activities. Requirements Bachelor’s Degree in Microbiology, Biotechnology, Life Sciences, Chemistry, or related scientific discipline. 3-4 years’ experience within a GMP pharmaceutical, API, or biopharmaceutical laboratory environment. Knowledge of microbiological testing, aseptic techniques, and GMP/GLP documentation practices. Experience working within regulated cleanroom or laboratory environments. Strong attention to detail, technical writing, and documentation skills. Good communication, teamwork, and problem-solving capabilities. Exposure to pharmaceutical or API manufacturing environments, including GMP compliance and laboratory support activities, is advantageous. Experience supporting investigations, laboratory deviations, or microbiological quality activities within manufacturing operations is preferred. #J-18808-Ljbffr
Independent Solutions is seeking a QC Micro Technician in Leinster, Ireland, to join a GMP-regulated Quality Control Microbiology laboratory. The ideal candidate will have a Bachelor's Degree in a related scientific discipline and 3-4 years' experience in GMP environments. Responsibilities include microbiological laboratory testing, environmental monitoring, and supporting compliance activities. Strong attention to detail and knowledge of aseptic techniques are crucial for success. This role operates on a shift-based schedule. #J-18808-Ljbffr
Independent Solutions is looking for a Laboratory Technician in Carlow, Ireland. The role is integral to maintaining operations within a GMP laboratory, including responsibilities such as cleaning, inventory management, and health & safety compliance. Ideal candidates should have experience in laboratory settings and a commitment to quality standards. The position offers comprehensive training and supports a culture of safety and teamwork. #J-18808-Ljbffr
Job Title: Laboratory Technician Employment Type: Full-Time (Contract – Day Role) Work Environment: GMP Laboratory Purpose of the Role: The Laboratory Technician will support day-to-day operations within a GMP laboratory by ensuring that facilities, equipment, and consumables are maintained in a safe, compliant, and efficient manner. The role is essential in maintaining laboratory readiness through effective cleaning, inventory management, and adherence to health, safety, and environmental standards. Key Responsibilities: Laboratory Support & Housekeeping Perform cleaning, washing, drying, and proper storage of laboratory glassware in line with GMP standards. Clean and sterilize laboratory equipment, utensils, and work surfaces. Carry out routine cleaning of laboratory areas in accordance with approved procedures. Maintain 5S standards across laboratory spaces, including fridges and freezers, ensuring proper organization and labelling. Inventory & Materials Management Monitor stock levels of laboratory consumables and materials. Restock supplies to ensure continuity of laboratory operations. Report shortages, damaged, or expired materials to relevant team members. Ensure proper storage of materials in line with GMP and defined conditions. Health, Safety & Environmental Compliance Adhere strictly to all health and safety guidelines, including proper use of PPE. Dispose of laboratory waste (hazardous and non-hazardous) in accordance with site procedures. Report any safety concerns, incidents, or near misses promptly. Support and promote a strong safety-first culture within the laboratory. GMP & Quality Compliance Perform all duties in accordance with cGMP, site procedures, and company policies. Maintain accurate documentation in line with data integrity principles. Support audit and inspection readiness by ensuring laboratory areas meet required standards. Communication & Teamwork Communicate effectively with team members regarding laboratory status, inventory, and safety concerns. Collaborate with colleagues to support daily laboratory operations and site objectives. Key Skills & Competencies: Strong attention to detail and commitment to maintaining high standards. Awareness of laboratory safety and compliance requirements. Good organizational and multitasking skills. Clear communication and teamwork abilities. Reliable and responsible approach to routine tasks. Qualifications & Experience (Desirable): Previous experience in a laboratory or GMP-regulated environment is an advantage. Familiarity with laboratory housekeeping, cleaning procedures, or inventory management. Basic knowledge of health and safety practices in a laboratory setting. Relevant training is beneficial; full training will be provided. #J-18808-Ljbffr
