- Posted 10 November 2022
- Salary Negotiable
- DisciplineLife Science
- Contact NameNicole Elphick
Orion Group are sourcing a QC Technical Writer (Environmental Monitoring) on behalf of our Multinational Biotechnology Client on an initial 12-month contract located in South Dublin.
This role will support qualification of a new production facility by writing qualification documents, SOPs, trend reports etc.
- Lead QC Technical documentation projects as an individual contributor.
- Accountable for timely completion of projects within the technical writing role.
- Collaborate with internal resources and business partners to support project requirements and ensure project completion.
- Work in accordance with cGMP and GLP requirements.
- Ensure consistent and good documentation practices are followed.
- Creation, review, and update of documentation, e.g., Laboratory Technical Protocols and Reports, Standard Operating Procedures, and Analytical Protocols.
- Translating complex topics into clear, concise, and understandable topics is required.
- Review standards for documentation types, structure, and assembly so that content is organised logically with the end reader in mind.
- Maintain Documents in the document management system.
- Support QC Specialist with risk assessments/procedures for new facility
- Working with the project team to ensure we have sufficient resources and equipment for the project
- Completing qualification works for the new isolator, media qualification etc
- Reading & review of EM plates.
- Execution of EM PQ of new facility.
Key Qualifications and Experience
- Bachelor's degree in a science discipline.
- Biopharmaceutical QC experience in Environmental Monitoring.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
- Experience in technical writing.
Preferred Qualifications and Experience
- Experience working in an aseptic cleanroom.
- Proficient in the use of LIMS & LMES.
- Technically strong background in microbiology and aseptic manufacturing.
- Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage.
- Flexibility - the EM role often encounters changing priorities on a daily basis.
- Good cross functional communication skills are essential.
- Presentation skills.
- Problem solving skills.
- Experience with Regulatory inspectors and interacting with inspectors desirable.
- Demonstrated ability to work independently and deliver right first-time results.
- Works under minimal direction.
- Follows procedures.
- Refers to technical standards, principles, theories, and precedents as needed.
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems.
- Demonstrated leadership and communication skills.
- Auditing documentation and operation process.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.