Auf einen Blick
- Aufgaben: Review batch records and ensure compliance in a GMP-regulated environment.
- Arbeitgeber: Join a leading pharmaceutical organization focused on quality and innovation.
- Mitarbeitervorteile: Collaborative work environment in Visp, Switzerland with professional development opportunities.
- Warum dieser Job: Make a real impact on product quality and compliance while working in a dynamic team.
- Gewünschte Qualifikationen: Experience in GDP/GMP environments; strong communication and problem-solving skills required.
- Andere Informationen: Fluency in English is essential; basic German knowledge is a plus.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
On behalf of our client, we are seeking a detail-oriented and proactive Batch Record Review and Support Specialist to join their team in Visp.
This role is critical in ensuring the accuracy and compliance of executed batch records within a GMP-regulated environment, supporting smooth operations and timely product releases.
Location: Visp, Switzerland
Contract Type: Contract
Duration: Until 14/07/2025
Start Date: ASAP
Workload: 100%
Your Responsibilities:
- Review executed electronic Batch Records, including cleaning logs, production documentation, temperature reports, test procedures (HEPT, FIT), equipment protocols (autoclave, washing machines), calibration records, sample results (LIMS), and logbooks.
- Evaluate and clarify review comments with the operations team and liaise with the responsible QA Manager.
- Initiate and support the resolution of deviations and investigations related to batch record observations.
- Assist in initiating Change Requests (CRs) and Temporary Change Requests (TCRs).
- Prepare documentation packages to facilitate timely QA release.
Your Background:
- Prior experience in GDP and GMP-regulated pharmaceutical/API industries is a strong advantage.
- Proven ability to identify non-compliance and quality standard gaps.
- Excellent communication skills and ability to collaborate effectively across interfaces within the organization; strong team player.
- Structured, organized, and focused approach to work with a solution-oriented mindset.
- Agile, motivated, and dynamic with the ability to deliver reliable results under pressure.
- Familiarity with MES Syncade and DeltaV systems is preferred.
- Fluent in English; basic knowledge of German is an advantage.
What’s on Offer:
- An opportunity to contribute to the quality and compliance of a leading pharmaceutical organization.
- A collaborative and dynamic work environment in Visp, Switzerland.
- A chance to develop professionally in a fast-paced, innovative setting.
If you are passionate about ensuring quality standards and compliance in the pharmaceutical industry and meet the above requirements, we look forward to receiving your application!
For more information, please contact:
Veronika von Mentzer, Recruiter
Email: #J-18808-Ljbffr
Batch Record Reviewer Arbeitgeber: Swisslinx
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Kontaktperson:
Swisslinx HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Batch Record Reviewer
✨Tip Number 1
Familiarize yourself with GMP regulations and the specific requirements for batch record reviews. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Highlight any previous experience you have in GDP and GMP-regulated environments. Be prepared to discuss specific examples where you identified non-compliance or improved processes, as this will showcase your expertise.
✨Tip Number 3
Brush up on your communication skills, especially in a team setting. Since the role involves liaising with various departments, being able to articulate your thoughts clearly and collaborate effectively is crucial.
✨Tip Number 4
If you have experience with MES Syncade and DeltaV systems, make sure to mention it. If not, consider doing some research or online courses to familiarize yourself with these systems, as they are preferred for this position.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Batch Record Reviewer
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Batch Record Reviewer position. Highlight key responsibilities and required skills, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize any prior experience in GDP and GMP-regulated environments. Provide specific examples of how you've ensured compliance and quality standards in your previous roles.
Showcase Communication Skills: Since excellent communication is crucial for this role, include examples in your application that demonstrate your ability to collaborate effectively with teams and manage cross-functional interactions.
Tailor Your Application: Customize your cover letter to reflect your passion for quality assurance in the pharmaceutical industry. Mention your familiarity with relevant systems like MES Syncade and DeltaV, if applicable, to strengthen your application.
Wie du dich auf ein Vorstellungsgespräch bei Swisslinx vorbereitest
✨Show Your Attention to Detail
As a Batch Record Reviewer, attention to detail is crucial. Be prepared to discuss specific examples from your past experience where your meticulous nature helped identify compliance issues or improved processes.
✨Demonstrate Your Knowledge of GMP Regulations
Familiarize yourself with Good Manufacturing Practices (GMP) and be ready to explain how you have applied these standards in previous roles. This will show that you understand the importance of compliance in the pharmaceutical industry.
✨Highlight Your Communication Skills
Effective communication is key in this role. Prepare to share instances where you successfully collaborated with teams or resolved conflicts, especially in relation to batch record observations or deviations.
✨Prepare for Technical Questions
Since familiarity with MES Syncade and DeltaV systems is preferred, review these systems beforehand. Be ready to discuss how you have used similar technologies in your previous positions and how they relate to batch record reviews.