PE Global are currently recruiting for a Sr QC Micro Analyst for a client site in South Dublin –
QC Micro – Snr Associate, Days Role.
This role will support qualification of a new production facility by writing qualification documents, SOPs, trend reports etc. The current expectation is to work days, however there may be a request to go on shift at a later date in order to support performance qualification of the new facility.
Specific Job Duties:
- 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.
Additional tasks:
- 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
Basic Qualifications
- Bachelors 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
- Experience working in an aseptic cleanroom
- Proficient in the use of LIMS & LMES
Competencies
- 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
- Work is guided by objectives of the department or assignment
- 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
- Demonstrated ability to interact with regulatory agencies
Interested candidates should send their CV to mailtoAudrey.mccarthy@peglobal.net or call 0214297900
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