Analytical Scientist - ASO Equipment Compliance
Full-time This is a permanent full-time position, working a 35-hour week flexibly Monday - Friday 07:00 - 19:00. Job Responsibilities: Check instrument calibration/service data (Performance Verification and Preventative Maintenance data) for multiple analytical instruments/equipment e.g. HPLC, Dissolution equipment, KF, stability chambers, etc. Write or update reports, SOPs, and Calibration Protocols. Support Internal Audits and regulatory inspections. Provide support to ensure compliance and integrity of quality systems to maintain GMP and any associated remedial activities. Support the introduction of new equipment/technology via documentation processes. Document data as dictated by clients' current policies and procedures. Ensure the client gets the best possible service by continually reviewing best practices in relation to both commercial and quality issues and ensuring 100% ethical work standards. Deal with client queries and contact designated personnel, with appropriate support from onsite leadership. Ensure the client’s requirements are fully met or exceeded and be flexible to work in any area of the business as required. Identify opportunities for improvement of quality and service and work with the team to implement continuous improvement. Work flexibly with multiple project teams as required. Support less experienced staff in techniques where the Scientist is competent. Attend meetings as required related to the scope of work (informal project discussions, group meetings, Town Hall meetings as appropriate to not impact workload commitment). Keep up to date with any technological advances in their area, ensuring their training is complete and adjusting their work as required with approval from the Lead Analyst. Minimum Requirements: A degree in a relevant scientific discipline such as pharmacy, pharmaceutical sciences, chemical engineering, or chemistry is required. Significant relevant experience may be considered in lieu of educational qualifications. A sound, fundamental knowledge of analytical chemistry techniques is essential, with specific reference to the qualification and validation of analytical equipment in a GMP setting. One to four years’ relevant experience of pharmaceutical product analysis and/or manufacturing within a group organization. Competent in authoring Quality documents based on templates, for example, Validation plans; Equipment Validation documents (URS, Third Party Protocol Approvals, Decommissioning documentation) would be beneficial. Competent familiarity with scientific instrumentation and scientific applications.
#J-18808-Ljbffr
Full-time This is a permanent full-time position, working a 35-hour week flexibly Monday - Friday 07:00 - 19:00. Job Responsibilities: Check instrument calibration/service data (Performance Verification and Preventative Maintenance data) for multiple analytical instruments/equipment e.g. HPLC, Dissolution equipment, KF, stability chambers, etc. Write or update reports, SOPs, and Calibration Protocols. Support Internal Audits and regulatory inspections. Provide support to ensure compliance and integrity of quality systems to maintain GMP and any associated remedial activities. Support the introduction of new equipment/technology via documentation processes. Document data as dictated by clients' current policies and procedures. Ensure the client gets the best possible service by continually reviewing best practices in relation to both commercial and quality issues and ensuring 100% ethical work standards. Deal with client queries and contact designated personnel, with appropriate support from onsite leadership. Ensure the client’s requirements are fully met or exceeded and be flexible to work in any area of the business as required. Identify opportunities for improvement of quality and service and work with the team to implement continuous improvement. Work flexibly with multiple project teams as required. Support less experienced staff in techniques where the Scientist is competent. Attend meetings as required related to the scope of work (informal project discussions, group meetings, Town Hall meetings as appropriate to not impact workload commitment). Keep up to date with any technological advances in their area, ensuring their training is complete and adjusting their work as required with approval from the Lead Analyst. Minimum Requirements: A degree in a relevant scientific discipline such as pharmacy, pharmaceutical sciences, chemical engineering, or chemistry is required. Significant relevant experience may be considered in lieu of educational qualifications. A sound, fundamental knowledge of analytical chemistry techniques is essential, with specific reference to the qualification and validation of analytical equipment in a GMP setting. One to four years’ relevant experience of pharmaceutical product analysis and/or manufacturing within a group organization. Competent in authoring Quality documents based on templates, for example, Validation plans; Equipment Validation documents (URS, Third Party Protocol Approvals, Decommissioning documentation) would be beneficial. Competent familiarity with scientific instrumentation and scientific applications.
#J-18808-Ljbffr
