Job Description
Scientific Technical Specialist required for 11-month contract in Carlow, Ireland, to generate and expedite review and approval processes for QC GMP documentation.
Orion Group Life Sciences is recruiting a Scientific Technical Specialist on behalf of a Multinational Biopharmaceutical Client. The successful candidate will be responsible for generating and expediting review and approval processes for QC GMP documentation, including Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, Standard Operating Procedures, Standard Work Instructions, and change controls. The role requires technical expertise and oversight of the above QC documentation to ensure compliance, safety, and reliable supply to customers.
Key Responsibilities:
- Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities.
- Author/Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit OOPCL completion.
- Be a document system expert; this will include document review, approval, and document system workflow expedition. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Documents will include SOP's, SWI's, training documents, and change controls.
- Support Laboratory activities through documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases, including the maintenance, auditing, and archiving of the process documentation system.
- Support Batch release through timely Investigations, Quality Notification, Out of Process Control Limit OOPCL completion, Interim/summary report generation; meeting batch release requirements.
- Perform Compendial Assessments.
- Author Annual Product Review, Trend Reports.
- Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues; implement subsequent corrective action through the change management system.
- Required to comply with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
- Assist in the management and/or assignment of QC training if required.
Qualifications/Education:
- Bachelor's Degree or higher preferred; ideally in a Science, or other technical discipline.
- Relevant experience in QC Laboratory within GMP setting.
- Proficiency in Microsoft Office and job-related computer applications required with proven analytical and systematic problem-solving skills.
- Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
- Report, standards, policy writing skills required.
- Analytical Method validation.
- Strong influencing skills.
- Flexible approach.
- Effective time management and multi-tasking skills.
- Proven organizational skills.
- Excellent attention to detail.
- Trouble shooting skills.
- Goal/results orientated.