46 Api Documentation jobs in Ireland

Documentation Specialist Upstream Operations

RK23951

Contract 11 months

Dublin

We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches. The Upstream Operations Support Specialist will support routine operations in the areas of safety and GMP compliance and will report to Upstream Operations Support Lead.

Key Responsibilities:

• As an Operations Specialist, you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
• Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
• Manage & track creation & updates to Standard operating Procedures (SOPs) Work Instructions (WI's) for New Product Introduction
• Ownership of CAPAs
• Support compliant operations through management of materials used in Upstream Operations.
• Data analysis supporting operations in safety quality delivery and cost
• Link to finance department for monthly materials reporting and approvals
• Liaise with stakeholders including Shift Operations, Tech Ops, Quality Assurance
• Collate and analyse downtime tracking data and link to problem solving.
• Provide Communication updates to manufacturing shift teams.
• Co-ordinate and support Audits including preparatory work.
• Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
• Co-ordination of Contractors and Visitors to BDS.

Education and Experience:

• Degree or 3rd level qualification (Science, Engineering).
• Working knowledge of SAP
• Experience with Qualified Document Management systems
• Working knowledge of Upstream processes is highly desirable.
• Knowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirements.

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

The Role

PE Global are recruiting for a
Documentation Specialist
for our client based in Sligo. This is an initial 12-month contract role. This role will be fully onsite.

Job Responsibilities

• Co-ordinate and/or execute internal and external operations review and approval of all manufacturing related documentation.
• Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP's.
• Be a reliable point of contact for the manufacturing area for clear and precise communication of the documentation process and status of documents.
• To co-ordinate processing of manufacturing documents into and out-of Documentation systems.
• A key member on the operations readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the manufacturing documents are prepared, executed and post approved in line with best practices and relevant timelines.
• Ensure highest Quality & Compliance standards.
• Track and trend relevant operations and business process metrics to ensure operations are performing effectively and efficiently.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Support the generation of efficient, user friendly documentation including SOPs and MBRs.
• Assist in the preparation of progress reports/presentations as required.
• Revise, update, and format documentation including MBR's, SOPs, forms, logbooks, and label templates.
• Write/review manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
• Will act as an SME for the operations function and also the wider organization in adherence to GDP guidelines.
• Will be flexible to take on additional tasks and responsibilities at the discretion of their manager.
• Applies knowledge, experience, and technical skills to understand Production objectives, to provide support to Production initiatives, to execute processes and procedures efficiently and compliantly, evaluates documents for improvement potential.
• Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the manufacturing department.
• Schedules and execute tasks, with limited assistance, to support manufacturing schedule timelines.
• Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinate referrals across the cross functional groups.
• Manages document review and approval to meet schedule timelines.
• Exercises judgment within generally defined procedures and practices to determine appropriate action.
• Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems.
• Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Investigates Documentation related events in production that have quality or compliance impact.
• Leads or participates IIA, RCI sessions.
• Documents investigation outcomes.
• Align processes with batch Records.
• Provides training to ensure successful rollout of new batch Records.
• Responsible for Inventory maintenance and MBR pre and post execution review and approval tracking.
• Subject matter expert in SAP for inventory and production.
• Support production and inventory management.
• Interface with Planning to create and manage production process order numbers and batch numbers.
• Initiate and track blanket purchase orders for goods and services to support production.
• Track weekly and monthly yield performance and report to Department supervision.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
• Comply with policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.
• Manage the Manufacturing Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.

Education & Experience

• Bachelor's Degree or equivalent preferential, preferably in a Science or related field
• Experience Level = 1+ Years
• Experience in a regulated manufacturing setting.
• Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred.
• Expertise with Microsoft Word with a solid understanding of the review and formatting tools is required.
• Expertise with Outlook, Visio, Excel, PowerPoint is required.
• Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required.
• Experience with the use of electronic systems to manage, edit and control documents is preferred.
• A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards
• Previous experience in a fast-paced and deadline driven environment is required.

Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Catalyx is seeking a Documentation Specialist to join our team and work on our customer site in Cork.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services RD, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit

The Role:

The Administrator / Documentation Specialist will be responsible for the creation, organisation, control, and management of key documents, ensuring accuracy, accessibility, and compliance with regulatory requirements. The role will involve collaborating with cross-functional teams, implementing document management best practices, and ensuring smooth information flow across departments.

Responsibilities:

• Create, edit, and maintain technical documents, SOPs, policies, user guides, and records.
• Develop and oversee document control systems, ensuring version control, accessibility, and regulatory compliance.
• Review and proofread documents to ensure accuracy, clarity, and alignment with company standards.
• Coordinate document workflows between departments, liaising with subject matter experts and project teams.
• Support preparation of documentation for audits, inspections, and regulatory submissions.
• Conduct regular internal audits of document systems to ensure consistency and completeness.
• Provide training and support to staff on document management processes and tools.
• Assist with general administration tasks, including scheduling, reporting, and supporting departmental activities.
• Maintain secure and organised filing systems (both electronic and physical) for easy retrieval.
• Contribute to continuous improvement initiatives in documentation and administrative processes.

Responsibilities:

• 5–7 years' experience in administration or documentation management, ideally within a regulated or technical environment.
• Strong proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Familiarity with document control or office management systems.
• Excellent written and verbal communication skills.
• Strong organisational skills with the ability to prioritise multiple tasks.
• High attention to detail and accuracy.
• Collaborative team player with strong interpersonal skills.
• Problem-solving mindset with the ability to streamline and improve processes.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

As a successful and rapidly expanding Irish-owned Biopharma Engineering Company based in Cork, Ireland, we are looking to recruit an Administrator/Documentation specialist. The position is permanent and is site-based in our Headquarters, Little Island, Cork. The role comes at a crucial stage in the company's continued growth; the successful candidate will play a key role in the continued and future growth of the company going forward.

About the role:

The Administrator / Documentation specialist role is a dynamic role with responsibility for providing administrative and documentation support in multiple areas across the company. The position requires strong organisational skills, attention to detail, and a proactive approach to problem-solving.

High-level Responsibilities:

Creating, organising, updating, and managing various documents, ranging from technical manuals and user guides to policy documentation and records. Key responsibilities include ensuring regulatory compliance, maintaining document control systems for version tracking, collaborating with cross-functional teams, and providing training on documentation processes.

Candidates should possess excellent communication, organizational, and detail-oriented skills.

Detailed Responsibilities:

• Document Creation & Management: Write, edit, and create new documents like technical manuals, user guides, and SOPs.
• Organization & Storage: Develop and maintain systems for organizing, storing, and archiving electronic and paper-based files.
• Quality Assurance: Review and proofread documents for clarity, grammar, accuracy, and compliance with organizational standards and legal requirements.
• Collaboration: Work with subject matter experts and other departments to gather necessary information and ensure documentation accuracy.
• Version Control: Track and control document versions and revisions to ensure the most up-to-date information is available.
• Accessibility & Retrieval: Ensure documents are easily accessible to authorized personnel and maintain processes for document retrieval.
• Training: Assist in training colleagues on document management processes and procedures.
• Compliance: Stay up to date with industry and regulatory requirements and implement changes as needed.
• Auditing: Conduct regular audits of document systems to ensure consistency and completeness.

Required Skills & Qualifications

• Strong Communication Skills: Excellent written and verbal communication to clearly convey information.
• Detail-Oriented: A keen eye for detail and accuracy to ensure all documentation is precise.
• Organisational Skills: Ability to manage multiple documents, maintain systems, and prioritize tasks effectively.
• Technical Proficiency: Experience with document management systems and software, such as Microsoft Office Suite.
• Interpersonal Skills: Ability to work effectively with cross-functional teams and collaborate with colleagues.
• Problem-Solving Skills: Analytical thinking and problem-solving to address documentation challenges.

Key Requirements:

• 5 to 7 years' experience in an administration/documentation-related role.
• Excellent Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Familiarity with office management software.
• Excellent written and verbal communication skills.
• Strong organisational skills.
• Ability to multitask and prioritise work effectively.
• Keen attention to detail.
• Ability to work well with others and contribute to a positive office culture.

Benefits & Culture:

• Competitive salary and benefits package including Company Health Scheme and access to Pension Plan.
• Opportunities for career advancement in a rapidly expanding company.
• A dynamic, supportive work environment with a focus on professional growth.
• Flexible working arrangements.
• Free on-site parking & access to EV Charging.
• Active Sports & Social Club

If you're a self-motivated, detail-oriented individual with a desire to contribute to the growth of an innovative biotech company, we encourage you to apply today.

Closing date - Friday 10th October, 2025.

Position Title:
Upstream Operations Documentation Specialist

Contract Type:
Fixed Term Contract – 12 Months

Location:
Dublin – Hybrid (4 days onsite, 1 day remote after initial training)

Start Date:
ASAP

Working Hours:
Day role (no shifts)

Industry:
Leading Pharmaceutical Manufacturing Company

Role Overview

An excellent opportunity has arisen for an
Upstream Operations Documentation Specialist
to join a leading pharmaceutical manufacturing organisation.

This role provides key operational support to the Upstream Manufacturing team, ensuring right-first-time batch execution and compliance with quality and safety standards. The position will initially be
fully onsite
during the training phase and will transition to a
hybrid model
(4 days onsite, 1 day remote).

The successful candidate will play a pivotal role in the production of biologics-based medicines, supporting operational excellence and continuous improvement across manufacturing activities.

Key Responsibilities

• Support the Integrated Process Team (IPT) to ensure effective, efficient, and on-time delivery of upstream batch production.
• Drive process reliability and operational excellence across Upstream Operations.
• Coordinate daily production activities and support achievement of key KPIs (EHS, production plan, compliance, training).
• Manage and track the creation and updates of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for new product introductions.
• Own and manage CAPAs, ensuring timely closure and documentation accuracy.
• Support material management processes within Upstream Operations.
• Perform data analysis to support operations in areas of safety, quality, delivery, and cost.
• Collaborate with Finance for monthly material usage reporting and approvals.
• Liaise with key stakeholders, including Operations, Technical Operations, and Quality Assurance.
• Collect and analyse downtime data to support root cause investigations and problem-solving.
• Provide communication updates to manufacturing shift teams.
• Coordinate and support audit activities, including preparatory documentation.
• Manage contractor and visitor coordination within the Biologics Drug Substance area.

Required Skills and Experience

• Proven working knowledge of
  SAP
  .
• Experience with
  Qualified Document Management Systems (QDMS)
  .
• Strong organisational and time management skills with a proactive approach.
• Ability to work both independently and collaboratively with cross-functional teams.
• Proficiency in
  MS Office Suite
  (Word, Excel, PowerPoint) to generate reports and metrics.
• Excellent written and verbal communication skills.

Desirable Skills

• Working knowledge of
  Upstream bioprocess operations
  is highly desirable.
• Familiarity with
  Lean Six Sigma
  and continuous improvement methodologies.
• Understanding of
  GMP and regulatory compliance
  in a manufacturing setting.

Education

• Bachelor's degree (or higher) in
  Science, Engineering, or a related discipline
  .

Why Join

This is a fantastic opportunity to contribute to a world-class biopharmaceutical manufacturing environment focused on innovation, quality, and patient impact. You'll collaborate with a diverse and inclusive team dedicated to continuous improvement and operational excellence.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary:

This position is to support Operations (Albumin Purification, Albumin Filling and Packaging) from the perspective of documentation, deviations, CAPAs and projects in order for smooth, efficient Operations. The Technical Document Specialist is responsible for using technical knowledge/concepts while partnering with manufacturing teams to create and revise manufacturing documents including PBRs, MBRs, SOPs, CCRs, Manufacturing Methods, deviation investigation reports, etc. Will ensure documents are streamlined, align with the manufacturing processes and procedures and comply with regulatory standards.

What will you be doing?

• Create, modify & streamline Operations documentation e.g. PBRs, MBRs, SOPs, OJT etc and ensure periodic review is completed within the required timelines.
• Consult with technicians to ensure ease of reading and understanding of documents, procedures, etc.
• Investigate, create, modify and execute Deviations, CAPA & Complaints, EC, Periodic review etc.
• Support Operations in Change Control and Risk Assessments administratively, by making sure that all documentation is in place and follow ups are appropriately completed to bring to closure.
• Collaborate with trainers to ensure clarity in regards to document revision training.
• Ensure correct revisions and documents are available when needed while also tracking all documents and their workflow.
• Provide reports and data defined by Supervisor and/or Management.
• Travel may be required from time to time to vendors or other Grifols sites internationally.
• Willing to upskill to as required by Grifols which may involve training course and/or further education.
• Perform other duties may be required as defined by Supervisor and/or Manager.
• Should be able to work independently and accountable for tasks and be able to drive tasks and escalating issues to supervision when needed.

Who will you be?

• Excellent communication skills
• Competent in Microsoft Word, PowerPoint, Excel
• Good organizational skills
• Flexibility
• Results orientated
• Knowledge and experience in SAP Production Modules an advantage
• Knowledge of manufacturing practices
• Knowledge of general GMPs of pharmaceuticals.
• Experience within upstream manufacturing, aseptic filling or Packaging operations
• Minimum of Third level education and 2 years of relevant pharmaceutical experience or in lieu at least 5 years' experience in pharmaceutical manufacturing role.

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates up to 7%
• 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. Golf, 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 – we're excited to hear from you.

Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)

Learn more about Grifols

PLEASE NOTE: This is a 12-month contract.

POSITION SUMMARY

This position will report directly to the Rathdrum Site Quality Systems and Standards (QSS) Lead. The Quality Documentation Specialist will serve as a partner alongside other functional leads to ensure all site documentation is managed through its lifecycle and assure its availability and readiness to support site operations.

The Quality Documentation Specialist will be responsible for the preparation and update of Quality documentation according to the site schedule and in accordance with the site Quality System and Electronic Document Management System Veeva Vault.

This Role will also support upload of site Documentation in support of the Learning Management System and will act as the site Records Management Lead for management of executed Quality Documentation in accordance with the Zoetis Record Retention Polices.

POSITION RESPONSIBILITIES

Key objectives of this position include:

1. Oversee the site SOP Management system and act as subject matter expert for key Quality Systems such as Veeva Vault and Learning Management System.

2. Ensure site Documentation (primarily GMP, EHS, and functional area operational procedures and instructions) are properly prepared and approved in accordance with the site Documentation Management System (Veeva Vault) and uploaded for training in the site Learning Management System.

3. Monitor progress vs site master documentation schedule and escalate issues in a timely manner to support resolution.

4. Administer the site Learning Management System and ensure availability of documentation to support training.

5. Act as site Records Retention Coordinator and manage control of all generated and executed records via the Records Management Process and IT tool.

6. Issuance of Analytical Records and Logbooks to support execution of testing.

7. Provision of document management system metrics and training reports as requested by functional areas.

Common Responsibilities for all Quality Colleagues

1. Active participation in site Tier meetings.

2. Active participation in Global Forums including knowledge sharing and networking within the platform.

3. Support Internal Inspection Readiness, Corporate and Regulatory Inspections.

4. Drive Continuous Improvement/5S initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met.

5. Serving as a Quality Culture role model and instill a strong quality and compliance culture across the site.

6. Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.

7. Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.

8. Perform role to a high standard and deliver on all assigned objectives/duties.

ORGANIZATIONAL RELATIONSHIPS

This position will need to achieve results through colleagues with a direct and indirect reporting relationship, as part of the site team. The successful candidate will need to interact regularly with leadership at the site (Site, Quality, Functional Area Leads) to assure quality goals and objectives are met.

All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.

All employees are expected to model inclusion behaviours and Zoetis Core Beliefs. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.

EDUCATION AND EXPERIENCE

· Leaving Certificate or equivalent qualification.

· Recognised Administration Qualification.

· Demonstrated proficiency with Computer Skills with expertise in Microsoft Office (Word, Excel, PowerPoint, Visio).

· Strong written and oral communication skills and ability to collaborate effectively with others.

· Prior Experiences working with Documentation Management and Learning Management systems in a similar role an advantage.

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

· Excellent organisational skills, methodical with the ability to work on their own initiative and be fully IT literate.

· Capable of working with minimum supervision in flexible, team-based environment, as well as experience working with leadership teams.

· Good interpersonal, communication and influencing skills.

· A clear, logical and challenging approach to problem solving.

· Assertive and demonstrated record in getting things done.

· Flexible, adaptable and receptive to new and innovative ideas.

· Proficient in English.

PHYSICAL POSITION REQUIREMENTS

Note the physical conditions in which work will be performed, if applicable to the position. Examples: ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.

· This is Rathdrum, Ireland Site based position.

· This position will require fluent use of teleconferencing tools, as well as SharePoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.

About Zoetis
At
Zoetis
, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Global Job Applicant Privacy Notice

The Quality Documentation Specialist, whilst reporting to the Quality Systems Manager at a Cork Facility, will have a hand in creating and managing manufacturing and production records. They will oversee document reviews to ensure compliance with quality standards. The right person for this role will have experience and be confident in conducting internal audits of the company's quality management systems. This is a Part-time Permanent Contract offering 32 hours/week.

Duties and Responsibilities

· Compilation of product handover packages and co-ordination of product certification

· Use of various client portals for distribution of documentation

· Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.

· Maintain a documentation system to ensure compliance & fast retrieval of documents.

· Responsible for training employees or records management procedures and policies, which include documentation, and retention.

· Support customer and ISO audits

· Support development and set-up of continuous improvement initiatives

· Ensure audit compliance of project documentation in conjunction with engineering team.

Education, Skills, and Experience required.

· Quality Assurance/Technical qualification desirable

· Minimum of 5 year's experience preferably in a manufacturing environment with quality management systems

· Technical Writing / SOP creation experience.

· Organised with strong attention to detail.

· Capable of efficiently prioritizing workloads and managing tasks effectively.

· Extensive knowledge of Microsoft Office

· Excellent presentation, communication, and interpersonal skills

· Ability to work effectively on own initiative and in a team environment with commitment to personal and professional development.

· Ability to always maintain confidentiality.

· Demonstrated Good Documentation Practices and compliance with procedures.

Job Types: Part-time, Permanent

Work authorisation:

• Ireland (required)

Work Location: In person