Compliance Expert:in
Compliance Expert (m/f/d) - GMP / Veeva / English / LEAN / QRM
Project: For our client, a large pharmaceutical company based in Basel, we are looking for a Compliance Expert (m/f/d)
Background: PTGA represents the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and supplies more than 120 countries. The Rocephin plant is an important part of the production center as a manufacturer of a life-saving broad-spectrum antibiotic.
The perfect candidate: As a compliance expert with a focus on Quality Risk Management (QRM) in the Rocephin operation, you and your colleagues ensure that the risks from technical changes and deviations are assessed, documented and approved in accordance with GMP requirements. As the contact person for the Rocephin value stream for risk management, you represent our value stream in site meetings. This means you have a key role in coordinating information from a variety of interfaces. The perfect candidate is a person who already has experience in creating risk analyses (classic FMEAs) and also has processes in aseptic filling and final packaging. Depending on the person's workload, supporting activities in writing deviations and batch records can also be undertaken.
Tasks:
• Responsible for compliance issues in the value stream such as quality risk management
• Presentation of risk assessments in inspections and audits
• Responsibility for processing deviations (DMS) and technical changes, with a focus on risk assessments
• Willingness to work in a self-organized team with a high degree of personal responsibility in an open and collaborative environment.
• Close cooperation with internal and external value stream interfaces to create risk analyses.
• Together with the QRM site team, collect ideas for improving the QRM processes in the QRM system (Veeva) and implement them as far as possible.
• If necessary, assist in carrying out checks for the completeness and accuracy of entries in the batch record.
• Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety.
Must Haves:
• Completed vocational training or a completed Bachelor's / Master's degree, ideally in the field of pharmaceutical manufacturing or a related field
• At least 3-5 years of professional experience in the QRM area in pharmaceutical production, development, quality assurance and control or a related industry, ideally additional experience in production (batches)
• Experience in risk assessment and the preparation of risk analyses (FMEA) in the GMP area
• Very good written and spoken communication skills in German and English
• Routine use of IT systems (e.g. Google applications and Veeva)
• Quick comprehension and great interest in technical processes as well as affinity for dealing with IT systems
• Great willingness and curiosity to develop flexibly and to learn across departments in the spirit of polyvalence. This includes an interest in understanding and getting to know upstream and downstream process steps
• A team-oriented mindset with a view to continuous improvement of processes and the ability to deliver consistent, high-level performance in a constantly changing environment
• High teamwork skills and solution orientation as well as collaborative working methods Working with various stakeholders is essential in this position, so the candidate's proactivity and initiative are very important
Nice to haves:
• Knowledge and commitment to process improvements (e.g. Lean Production System) as well as Agile Management or microbiological knowledge are an advantage.
• Ability and openness to recognize and live the opportunities and advantages of change. In this sense, an interest in the areas of coaching and change management is an advantage.
• Experience in dealing with deviations (DMS) and technical changes is an advantage
Reference No.: 923548TP
Role: Compliance Expert:in
Industry: Pharma
Location: Basel
Workload: 100%
Start: 01.08.2024
Duration: 12++
Deadline: 21.07.2024
If this position has aroused your interest, please send us your complete dossier via the link in this ad. If this position does not match your profile and you would like to receive another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com . Contact us for more information about our company, our positions or our attractive payroll-only program: +41 41 760 77 01.
About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for temporary staffing in the IT, Life Science & Engineering sectors. We offer temporary staffing & payroll services. This is free of charge for our candidates, and we do not charge you any additional fees for payroll either.
