For our customer located in Neuchatel/Switzerland we are currently looking for a: QC Analyst microbiology (m/f/d)
Tasks & Responsibilities
The work consists of carrying out analysis and supervision activities according to the procedures in force at the laboratory in compliance with GMP rules and/or projects related to the activities of the Quality Control department.
- Perform analyses or approvals of analyses at the QC laboratory according to applicable procedures and standards, e.g., cGMPs and pharmacopoeias based on planning priorities.
- Comply with all the rules outlined in the SOPs in the laboratory
- Perform laboratory activities with the SOP in effect open.
- Fill in the various forms, logbooks and documents in compliance with Good Manufacturing and Documentation Practices + results management system(s)
- Notify the Supervisor/Delegate/Expert in case of non-compliant and/or invalid results on the same day orally and/or in writing and initiate the event in the quality system within the given deadlines.
- Respect and enforce EHS rules. If he observes deviations from these rules on the part of colleagues or external stakeholders, he also plays an active role by reminding the people concerned of the application of the EHS rules. The employee is also required to open EHS events within the stipulated time frame.
- Proactively report any deviations from the schedule to the person in charge of the schedule and the supervisor/delegate
- Complete Smart QC at the beginning and end of each activity
- Execute reagent/consumable qualification protocols, validation protocols (method, system, equipment) and recalculations in the results management system
- Reconcile controlled documents and print if applicable
- Enter results and supervise results from external laboratories
- Inform the equipment manager if a deviation is identified on the equipment
- Perform regular GEMBAs in the laboratory and alarm review according to current procedures
- Manage and tidy up the laboratory in general, comply with 5S standardization standards
- Be responsible for procedures concerning its methods and their updating
- Always be up-to-date in terms of training (SABA) and Complete training on time
- Ensure that the calibration and maintenance of equipment is in order during analysis
- Respect Kanban management in real time
- Report to the Method/Equipment Manager and the Supervisor/Delegate/Expert any deviations from the procedure
- Be able to identify and solve some less complex problems related to his/her area of expertise (Troubleshooting)
- Support continuous improvement initiatives and GEMBAs and HOPs
- Train analysts on equipment and be backup trainer for GMP training
- Have system, equipment and method knowledge for equipment
- Be responsible for equipment logbooks (completion, monthly review) if applicable
- Train analysts at the workplace for equipment if applicable
- Follow suppliers in the field during maintenance and unplanned interventions on equipment as backup to the manager
- Contact the supplier in case of technical problems on his equipment as a backup of the equipment / method
- Be responsible for the procedures concerning the equipment and their updating
- Complete the equipment management systems (e.g. RAM and Bolton)
- Participate in the management of deviations from the protocol
- Support the quarterly review of disabled persons
- Produce quarterly and annual trend reports of identifications
- Train apprentices if applicable
- Present your subject of expertise, deviations during inspections
- Have the system, equipment and method knowledge for his/her field of expertise
- Manage OOL and invalid on its methods and deviations in the system and be the expert on the content; find the root cause and associated CAPA
- Learn about new technologies and propose improvements
- Be the supervisor’s backup
- Actively participate in equipment and methods risk analyses
- Support periodic system reviews and ATR-AR
- Be able to identify and solve complex problems related to his/her field of expertise
- Contact the supplier in case of technical problems on his equipment or his method in back-up of the QC Equipment Lifecycle group
- Follow up with suppliers in the field during maintenance, unplanned intervention in the back-up of the QC Equipment Lifecycle group
- In collaboration with QC Sciences, participate in the improvement/harmonization of inter-site
methods and be the support for regulatory submissions - Support projects as an EMS
- If necessary and in agreement with the laboratory manager, initiate and support corrective and preventive actions in the laboratory.
- Decide on the results of the analyses rendered (validity and compliance)
- Refer to his/her superiors in case of conflicts of priorities and non-compliant results
- Work on the analysis or approval of results (e.g. entry of results and approval) with external partners (analysis subcontractors, suppliers, etc.) and internal partners (other departments and client sites).
- Present your areas of expertise in inspections or audits to health
Must Haves
- Minimum CFC in microbiology or equivalent experience in pharmaceutical or biotechnology industries
- Experience of 2-5 years in a cGMP laboratory or 2 years minimum as an Analyst I
- Experience of minimum 5 years in a cGMP laboratory or minimum 5 years as an Analyst II
- Very good knowledge of laboratory methods
- Good knowledge of cGMP
- Very good knowledge of Data Integrity
- Be comfortable with the usual computer and office tools (Office pack)
- French and English (technical)
- English (B2 minimum)
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.