94 Manufacturing Qa jobs in Ireland

Associate Director Manufacturing & Quality Technical Learning & Development Our client, a global pharma company, are currently recruiting for an Associate Director Manufacturing & Quality Technical Learning & Development to join their team on a permanent basis.

As Associate Director for Technical Learning & Development, you will lead site-level learning strategies for Manufacturing, Quality, Health & Safety, and Central Functions.

This role offers the opportunity to shape workforce development and learning in a cutting-edge, next-generation drug substance manufacturing facility.

Responsibilities: Serve as the site lead for technical Learning & Development, aligning with global frameworks while addressing local needs Partner with senior leaders and the global Centre of Excellence to deliver future-focused learning solutions Design and implement site-specific site technical Learning initiatives that support compliance, manufacturing excellence, and employee development Ensure governance, compliance, and audit/inspection readiness at all times and proactively address training gaps and regulatory expectations Champion modern, technology-enabled learning (digital, interactive, experiential) Lead and develop the site L&D team, fostering innovation and continuous learning Design and implement training programs that strengthen compliance and workforce capability Collaborate cross-functionally with Operations, Quality, HR, and SMEs Use data and analytics to measure training impact and drive improvements Requirements: Bachelors degree minimum Minimum 5 years of experience in Learning & Development, Talent Development Manufacturing Training with a focus on regulated environments Strong knowledge of GMP and compliance training Proven leadership of L&D teams in a manufacturing or regulated setting Experience in governance, audit readiness, and inspection preparation Familiarity with modern learning methods (competency-based, digital, AI-driven) Strong stakeholder management and cross-functional collaboration skills Excellent communication, project management, and change management experience Ability to analyse data and provide strategic insights For more information please contact Sinéad Cullen on or

**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia, and other serious vascular conditions.
**We are currently looking for Manufacturing Engineers and Quality Engineers to join our modern site in Clonmel.**
**This is how you will make a difference:**
As a Manufacturing Engineer, you will be responsible for engineering support of manufacturing operations, which will involve key engineering metric management and process optimization activities including Manufacturing Yield improvement, product quality monitoring, lean manufacturing design and material/equipment/process troubleshooting using continuous improvement tools and methodology. Working as part of the operations support team, the manufacturing engineer will liaise with operations, quality, R&D and materials & purchasing departments to ensure quality and efficient manufacturing operations.
**Main responsibilities**
+ Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
+ Prepares reports, publishes, and makes presentations to communicate findings.
+ Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
+ Understands engineering principles theories, concepts, practices and techniques.
+ Understands the business needs of the company, and has knowledge of the customer needs of our business.
+ Understands the business cycle and foresight of emerging technologies trends.
+ Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees.
+ May lead a project team, determining goals and objectives for the projects.
+ Mentors employees by sharing technical expertise and providing feedback and guidance.
+ Interacts cross functionally and with internal and external customers.
+ Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
+ Acts as a spokesperson to customers on business unit current and future capabilities.
+ Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
**Experience, Education and Skills Required - Manufacturing Engineer:**
+ National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.2+ years of related work experience, or an equivalent combination of education and work experience.
+ Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function.
+ Learns to use professional concepts and company policies and procedures to solve routine problems.
+ Developing a network of internal resources to facilitate completion of tasks.
**JOB DESCRIPTION:**
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**Purpose Statement:**
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Shift Role: 2-cycle shift (8-16:30 and 16:30-00:30)
**Key Responsibilities - Quality Engineer:**
1. Identifies manufacturing process defects (scrap, non-conforming material, customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
2. Assists in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and Failure Mode Effect Analysis' (FMEAs).
3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
4. Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
**Education & Job Skills - Quality Engineer**
+ (Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience.
+ (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
+ (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
+ (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule.
+ (Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
+ (Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

An exciting opportunity has arisen for a Quality Assurance COE (Centre of Excellence) Specialist to join our team in Biotech Swords, Co. Dublin. The role ensures that the QA team objectives are effectively achieved, consistent with the companys requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations. This position will report directly to the Quality Assurance COE Lead for Biotech Dublin. With energy, knowledge & innovation, the QA COE Specialist will: Support various site functional and cross functional tier structures. Completes review and approval for CAPAs, change requests, and investigative protocols and final reports. Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, supplier management system upkeep. Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering and Warehouse throughout the product lifecycle e.g. method validation, facility upgrades, qualification protocols, calibration records. Review and approve GMP documentation / data for accuracy and completeness. Working cross functionally to ensure projects milestones are met in a timely manner. Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans. General A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Strong collaboration and cross-functional leadership skills. Strong verbal and written communication skills, project management skills. Technical & Education Bachelors degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline. 5 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. 2 years of experience in performing the release function in a regulated environment Strong knowledge of qualification and implementation of Single Use technologies and raw materials for use in a GMP environment. Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Proven track record in delivering excellence. Knowledge of SAP, KNEAT and Veeva system is an advantage. Skills: SAP KNEAT CAPA Single Use Technology

The Quality team have a great opportunity for a Quality Assurance Senior Specialist at our Dundalk facility. QA CSQ/CQV specialist contractor/Consultant, he will be reporting to the QA CSQ/CQV Lead. This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP, and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs), and shipping. An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the Dundalk Facility start-up project and 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. Other quality activities as needed and assigned. Special knowledge 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. Skills Independent and self-motivated. Able to multi-task in fast-paced, dynamic working environment. Strong planning, organisational, and time management skills. Critical thinking skills. Able to operate across functional boundaries, both internal and external. 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. Skills: CQV CSQ Validation GxP cGMP

Position Brand Description: The API EM Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Specialist position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Key Objectives/Deliverables: Serve as a liaison between CMs and company. Provide quality oversight of CMs including being the initial point of contact for all quality-related issues. Escalate quality issues at CMs to company QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). Provide quality oversight of the companys/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments. Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. Participate on the Technical Review Board Evaluate and disposition API batches, if required. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable. Ensure all processes are in an appropriate state of control. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations. Participate in APR activities. Participate in projects to improve productivity. Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. Basic Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences. Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering. Additional Preferences: Experience in quality support for Quality Control activities Thorough technical understanding of quality systems and regulatory requirements. Knowledge of pharmaceutical manufacturing operations. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Ability to influence diverse groups and manage relationships. Education Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences. Skills: External Manufacturing Contract Manufacturer Review Approval API

Purpose The Quality Assurance Specialist is a vital partner to our Integrated Production Team (IPT), ensuring the highest standards of quality and compliance are met in our sterile manufacturing facility. Your primary purpose is to safeguard product quality and patient safety by providing real-time quality oversight, reviewing critical processes, and fostering a culture of continuous improvement and cGMP excellence. You will be the on-the-ground quality expert, responding to events and ensuring our operations are always audit-ready. Shift Pattern:4-shift pattern - 12 hours per shift Week 1- long week: Monday Tuesday Days then Fri, Sat, Sun nights Week 2- short week: Wed and Thurs Days, Week 3:Long week: Monday Tuesday nights, Fri, Sat, and Sun days Week 4: short week: Wedand Thurs nights Responsibilities Perform timely and detailed reviews of batch documentation, including Electronic Batch Records (EBRs), line clearances, and associated reports. Identify, highlight, and assist in the resolution of quality concerns, ensuring actions are commensurate with risk. Support the spot check and walk-through process of the production lines to verify adherence to cGMP. Respond quickly to unplanned events and technical issues, providing immediate quality guidance. Support and review investigations, including customer complaints, to ensure root causes are identified and effective CAPAs are implemented. Utilize quality systems (e.g., Trackwise, SAP, MES) for managing deviations, CAPAs, and change controls. Conduct, report, and display Quality Right-First-Time and audit readiness metrics weekly to drive continuous compliance. Liaise with department representatives to promote improvements in GMP and quality standards.: Provide daily Quality support to IPT production teams, acting as a subject matter expert on quality matters. Ensure compliance with our Company's Manufacturing Division, Quality, and EHS (Environment, Health, and Safety) Management System requirements. Requirements Bachelors Degree or higher in a Science discipline (Microbiology, Chemistry, Pharmacy, or related field) is preferred. Minimum of 1-2 years of experience in a Quality role within a pharmaceutical manufacturing facility; experience in aseptic/sterile manufacturing is highly preferred. Demonstrated operational experience with quality systems such as SAP, Trackwise, and MES (Manufacturing Execution System). Essential:Strong technical knowledge of sterile manufacturing processes and a full understanding of cGMP and GDP principles. Essential:Working knowledge of Irish, EU, and US regulatory requirements for sterile products. Proven ability to prioritize multiple tasks, manage deadlines, and work effectively in a dynamic, fast-paced environment. Strong problem-solving skills with the ability to make risk-based decisions. Excellent communication and report-writing skills. Competent in the use of Microsoft Office applications. Skills: Aseptic Manufacturing Experience SAP MES Trackwise Quality GMP

Position Brand Description: The API EM Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Specialist position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Key Objectives/Deliverables: Serve as a liaison between CMs and company. Provide quality oversight of CMs including being the initial point of contact for all quality-related issues. Escalate quality issues at CMs to company QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). Provide quality oversight of the companys/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments. Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. Participate on the Technical Review Board Evaluate and disposition API batches, if required. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable. Ensure all processes are in an appropriate state of control. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations. Participate in APR activities. Participate in projects to improve productivity. Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. Basic Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences. Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering. Additional Preferences: Experience in quality support for Quality Control activities Thorough technical understanding of quality systems and regulatory requirements. Knowledge of pharmaceutical manufacturing operations. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Ability to influence diverse groups and manage relationships. Education Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.

About the QA Specialist Job: Our client, a leading food production company in the North East , is seeking a QA Specialist. Ideally you will have some post graduate expereicne although my client will also consider recent food sciennce graduates as full training will be provided. Commutable from: Monaghan Town, Clones, Cootehill, Ballybay, Carrickmacross, Castleblayney, Armagh, Dungannon, Enniskillen, Cavan, Belturbet, Killeshandra, Lisnaskea, Roslea, Emyvale, Aughnacloy, Threemilehouse, Ballinode, Scotstown, Newbliss and Scotshouse. Key Responsibilities: In the QA Specialist job some of your key duties will include: * Assist in carrying out internal audits on a routine basis/ ensure the factory is compliant with all quality regulations & requirements. * Maintain detailed and accurate records of all quality checks performed during production. * Ensure HACCP, VACCP and TACCP principles are continuously met and BRC requirements are maintained * Ensure cross-checking traceability for each delivery and contact all suppliers to obtain traceability in advance. * Work closely with the production team to uphold and improve quality standards. * Analyse Production Quality KPI's and proactively report trends and liaise with production teams & Farm Officers in problem solving. * Support with development, implementation, and management of food safety management systems (FSMS) * Proactively identify and address hazards to prevent risks to product safety, initiate corrective and preventative actions, and oversee their effective implementation to address problems and drive continuous improvement. * Work closely with the QA Manager to review external non-conformance and complete complaint investigations, to ensure a rigorous approach to root cause analysis and that corrective and preventative actions are put in place in a timely manager. What We're Looking For: * Excellent attention to detail & organisational skills in relation to quality, traceability, labelling and maintaining records. * Previous experience in a similar role or within the food industry is an advantage, but not essential-full training will be provided. * 3rd level qualification in relevant discipline (e.g. Food Science/Food Manufacturing/Food Safety) desirable * Working knowledge of BRC, HACCP and Food legislation an advantage What's on Offer: Opportunity to fast-track your career in a rapidly growing food production company with a salary of 32k-35k doe. Keywords: QA, QA Specialist, Food Production, Manufacturing, Monaghan, Permanent INDFRS1 Skills: Monaghan QA Specialist Food Production

The Quality team have a great opportunity for a Quality Assurance Senior Specialist at our Dundalk facility.

QA CSQ/CQV specialist contractor/Consultant, he will be reporting to the QA CSQ/CQV Lead.

This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, c GMP, and company SOPs.

It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs), and shipping.

An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the Dundalk Facility start-up project and 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 c GMP 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 c GMP 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.

Other quality activities as needed and assigned.

Special knowledge Deep knowledge of Gx P 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.

Skills Independent and self-motivated.

Able to multi-task in fast-paced, dynamic working environment.

Strong planning, organisational, and time management skills.

Critical thinking skills.

Able to operate across functional boundaries, both internal and external.

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 c GMP manufacturing facility.

Strong technical aptitude is required.

Skills: CQV CSQ Validation Gx P c GMP