You are a Quality Control Analyst and you are looking for a new challenge ? We have your new opportunity. For one of our client based in Neuchâtel we are looking for a Quality Control Analyst, Equipment Specialist.
- Purpose and Scope of Position
The main responsibility of the position will be to perform super user activities for the laboratory computerized systems, including Master Data Management activities, and associated GMP document updates. The QC Analyst – Equipment Specialist will act as a Super user providing support and training to End-Users of the QC laboratories as well as supporting investigations and resolution of issues.
The QC Analyst – Equipment Specialist will also support activities related to acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories.
All activities are carried out in compliance with laboratory procedures and safety rules (EHS) as well as good documentation and manufacturing practices.
- Required Competencies: Knowledge, Skills, and Abilities
- CFC as Laboratory Technician or BS degree in Science, Chemistry, or equivalent.
- A minimum of 2 years of relevant work experience in a GMP regulated environment (or equivalent). Previous experience of laboratory equipment qualification is a plus.
- Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices.
- Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
- Good knowledge of basic coding and code reviews.
- Good knowledge of LIMS, Oracle and Empower applications.
- Good scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS, potentiometry and IR techniques.
- Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
- Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
- Professional command of French and English, verbal and written.
- Proven time management skills and a strong attention to detail.
- Proven analytical and problem-solving skills.
- Ability to work independently and compliantly.
- Duties and Responsabilities
Super user of laboratory computerized systems:
- Performs master data management activities in computerized systems (e.g LIMS, Oracle, Empower, Dissolution Workstation, Tiamo, etc.)
- Updates associated GMP documents and procedures.
- Performs audit trail reviews, system periodic review, assures adherence to data integrity principles.
- Provide first line contact with QC End Users and QA e-Systems in case of software issues.
- Leads or supports investigations in case of system-related deviations.
- Leads or supports corrective and preventive actions implementation related to Oracle or QC software.
- Assists with errors and solve problems with minimum guidance; performs simple data fixes.
- Owns or support change controls for QC software changes.
- Provide end user training and on-the-job training for new employees where required.
- Supports risk assessments
- Performs other tasks as assigned.
Commissioning and Qualification Activities.
- Participate in acquisition and qualification of new analytical equipment.
- Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC
- Owns or support change controls for QC equipment changes
- Performs feasibility experimental work as needed
- Configures user profiles and methods on the instrument.
- Can be assigned special tasks and project work
- Support laboratory investigations in case of equipment-related deviations. Defines corrective and preventive actions.
- Support End-User with equipment troubleshooting
- Supports risk assessments
- Performs other tasks as assigned