About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for a motivated Senior Scientific Associate to join our Metrology and Calibration Team !
Responsibilities:
The Senior Scientific Associate, Metrology & Calibration, under minimal supervision, contributes to the development and evaluation of GMP analytical systems in ADQC department. This role generates, reviews, and executes protocols for new/existing instruments and is involved in the investigation and evaluation of instrument failures. Works with QA and the labs to develop corrective action and preventive action. The incumbent is also responsible for writing and revising SOPs and qualification protocols related to instrumentation. Monitors industry sector trends to maintain compliance with FDA, USP and other industry recognized agencies. The Quality Specialist will have additionally the following responsibilities and tasks which are related to the company site Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland:
- Responsible for metrological activities for Analytical Development and Quality Control Laboratories.
- Supports the development and evaluation of GMP analytical systems in ADQC labs:
• Verifies that systems are working properly, organizes repair if needed prior to releasing to analyst.
• Reviews calibration certificates and investigates if failures occur.
• Contacts and negotiates with vendors and contractors for the repair, calibration, preventive maintenance and qualification of analytical instruments.
• If there is failure during analysis or testing, he/she is involved in the investigation and evaluation of the instruments.
• Works with QA and the labs to develop corrective action and preventive action.
- Involved in qualification and validation activities, including the following:
• Generates user requirements.
• Generates, reviews, and executes the IQ/OQ/PQ (installation, Operational and Performance Qualification) protocol for the new and existing instruments.
• Writes the summary report.
• Explains in writing with QA if there is any deviation.
- Supports procurement of instruments by evaluating compliance to regulations.
- Coordinates Maintainance, repairs, calibrations, and qualifications from simple to moderate analytical instrumentations in both QC and A&D laboratories to ensure that all analytical instruments are in good working condition in compliance with cGMP.
- Minimizes instrument downtime, reduces cost and maximizes availability by ensuring that instruments are repaired on time and calibrated / qualified in a timely manner to increase lab efficiency and productivity.
- Generates respective documentation for new instrument purchases.
- Generates Change Controls through Veeva system and the IT Change Management System to support instrument installs and relocations.
- Reviews qualification/validation protocols and ensures complete adherence to protocols during executions. Work with QA to obtain pre-approval of protocol and approval of reports.
- Works closely with IT to implement new software technology and support upgrades for existing software.
- Works closely with Engineering to coordinate site prep for new instrument installs or relo’s.
- Maintains SOP calibration, qualification and related records. Monitors industry sector trends to maintain compliance with FDA, USP and other industry recognized agencies.
- Writes/revises SOPs and qualification protocols of new and existing instruments to mantain compliance.
• Writes internal calibration procedures.
• Establishes instrument ranges and tolerances.
- Supports QA and FDA walk-through Audit and provides responses to QA and FDA observations.
Requirements :
• Bachelor’s degree or Master’s degree in chemistry, Biochemistry other relevant science discipline required with at least 4 years of experience working in a biotechnology or pharmaceutical company in a technical role.
• Must have hands-on maintenance and calibration related experience for equipment used in QC and R&D Laboratories including but not limited to: HPLC,UPLC, GC, UV/Vis, FTIR, Particle Size Analyzers, and Dissolution systems. Working knowledge of Waters Empower Chromatography Data Acquisition Systems.
• Knowledge in Analytical Equipment Qualification that includes IQ/OQ/PQ and qualification lifecycle.
• Familiar with chromatographic data systems/databases, such as Waters Empower application software.
• Good understanding of cGMP and FDA requirements (21 CFR Part 11 and part 211).
• Able to troubleshoot and maintain simple to moderate analytical laboratory instruments such as HPLC, UV/Vis, GC, Dissolution Testers, and FTIR.
• Working knowledge of Empower, Chromeleon, Veeva software.
• Experience working with multidisciplinary teams in a matrix environment.
• Broad understanding of biopharmaceutical analytical activities.
• Experience with evaluating and implementing new and novel technologies.
• A good understanding of cGMP, CSV and data integrity principles.
• Good organization/time mgt skills; manage time effectively to complete assignments in expected time frame.
• Fluent in English.
What Idorsia offers
• Exciting opportunities for development and professional growth within our dynamic organization
• A collaborative and solution oriented environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
Work Location: Allschwil-Basel Area
Country: Switzerland
Business Area: Analytical Development and Quality Control Department - Metrology and Calibration
Schedule: Fulltime
Job Type: Permanent
Job ID: 2090
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.
Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.