Job Details
Laboratory Documentation Specialist
- ID
- 14917
- Location
- Limerick
- Role Type
- Contract
Laboratory Documentation Specialist
Contract Role
Limerick
May consider part time candidate: 3-4 days
As a Laboratory Documentation Specialist, the candidate will play a pivotal role in maintaining high-quality documentation for our laboratory operations. This desk-based position requires expertise in managing and organising detailed documentation, ensuring compliance with regulatory standards, and contributing to the smooth running of laboratory activities. The ideal candidate will have both hands on and desk based experience, have a keen eye for detail, strong organisational skills, and the ability to work collaboratively across multiple teams. The successful candidate will oversee process development, validation, and regulatory compliance, ensuring the highest standards in chemistry, manufacturing, and controls (CMC). This position is ideal for those looking to make an impact in the pharmaceutical and medical device industries while working in a collaborative, innovative, and supportive environment.
Key Responsibilities
.
- Support New Product Introduction: Assist in assessing and implementing proposed manufacturing processes, offering guidance throughout product development and changes.
- Documentation Management: The candidate will be responsible for ensuring all laboratory documentation is accurate, up to date, and compliant with internal and external standards. This includes creating, editing, and reviewing documents related to laboratory procedures, experiments, and regulatory requirements.
- Data Entry and Analysis: the candidate will manage data input into laboratory systems and ensure all information is recorded systematically. Strong analytical skills will be essential to review data trends, identify discrepancies, and ensure consistency in reporting.
- Collaboration Across Functions: Work closely with R&D, Production, Quality, and Regulatory teams to ensure the smooth implementation of projects.
- CMC Expertise: Provide specialist knowledge in CMC, supporting the selection, qualification, and auditing of contract manufacturers and API vendors.
- Regulatory Strategy: Contribute to the development of CMC strategies for global regulatory submissions and interact with global teams to implement these strategies.
- Compliance with Global Standards: Maintain high-level expertise in FDA, US Pharmacopeia, European Pharmacopeia, and ICH guidelines.
- Investigation and Root Cause Analysis: Support OOS investigations, ensuring consistency with methodologies and regulatory expectations.
- Cross-functional Interaction: Work with Post Market and Manufacturing Engineering teams to achieve objectives and ensure smooth project completion.
- Reporting: Provide regular updates to the Engineering management team on progress and activities.
- Compliance and Quality: Ensure all activities align with Code of Conduct, Quality System requirements, and Company HR policies.
Qualifications and Requirements
- Education: Bachelor’s degree (Master’s or PhD preferred) in Engineering, Science, or a related field.
- Experience: A minimum of 3 years’ relevant experience in CMC within the pharmaceutical or medical device industry.
- Knowledge: Strong understanding of medical device quality standards (ISO 13485, FDA practices), GMP, GLP, and relevant regulatory guidelines (FDA, US/European Pharmacopeia, ICH).
- Skills: Excellent problem-solving, analytical, and interpersonal skills with the ability to work effectively across functions. Communication very important
- Technical Expertise: Familiarity with statistical methods, data analysis, and interpretation.
- Software Skills: Proficient in Microsoft Office software.
- Travel: Willingness to travel on company business as needed.
For further information on this role please contact Hannah Talbot
Phone: 086 107 0950
Email: engineering@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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