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- Aufgaben: Review electronic Batch Records and support QA processes in a dynamic pharmaceutical environment.
- Arbeitgeber: Join a global leader in active pharmaceutical ingredient production and process support.
- Mitarbeitervorteile: Contract role with potential extension, working in beautiful Valais, Switzerland.
- Warum dieser Job: Be part of a crucial team ensuring quality in pharmaceuticals while developing your skills.
- Gewünschte Qualifikationen: Degree in relevant fields or experience in the pharmaceutical industry; strong communication skills required.
- Andere Informationen: Fluency in English is essential; basic German knowledge is a plus.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
Batch Record Reviewer (GMP) – 6289
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Batch Record Reviewer and Support Specialist for a contract role starting as soon as possible until July 2025 (extension possible) based in the Valais area , Switzerland.
Main Responsibilities:
- Review of the executed electronic Batch Records (e.g., cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
- Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
- Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
- Support the initiation of CRs and TCRs
- Support preparation of documentation package to enable fast release by QA
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Degree in Biology, Chemistry, Biotechnology, Life Science or other related field or experience in the field of pharmaceutical industry
- Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
- Ability to identify non-compliance and gaps from quality standards
- Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
- Structured, focused and well-organized working attitude
- Open-minded for new ideas and suggestions; solution-oriented
- Agile, highly motivated and dynamic drive
- Ability to produce reliable results under stress
- Knowledge of MES Syncade, DeltaV system (preferably)
- Fluent in English (German basic knowledge is an advantage)
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Batch Record Reviewer (6289) Arbeitgeber: CTC Resourcing Solutions
Kontaktperson:
CTC Resourcing Solutions HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Batch Record Reviewer (6289)
✨Tip Number 1
Familiarize yourself with the specific electronic Batch Record systems mentioned in the job description, such as MES Syncade and DeltaV. Having a solid understanding of these systems will not only boost your confidence during the interview but also demonstrate your proactive approach to the role.
✨Tip Number 2
Brush up on your knowledge of GMP and GDP regulations, as well as common non-compliance issues in the pharmaceutical industry. Being able to discuss these topics intelligently will show that you are well-prepared and serious about the position.
✨Tip Number 3
Prepare examples from your past experiences where you successfully identified and resolved quality compliance issues. This will help you illustrate your problem-solving skills and your ability to work under pressure, which are crucial for this role.
✨Tip Number 4
Since communication is key in this role, practice articulating your thoughts clearly and concisely. Consider conducting mock interviews with a friend or mentor to refine your communication skills and ensure you can effectively interact with various teams.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Batch Record Reviewer (6289)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Batch Record Reviewer position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience in the pharmaceutical industry, particularly in GDP and GMP regulated environments. Mention specific tasks you've performed that relate to batch record review or quality assurance.
Showcase Communication Skills: Since the role requires good communication skills, provide examples in your application of how you've effectively interacted with teams or resolved issues in a collaborative manner.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements mentioned in the job description. Use keywords from the listing, such as 'non-compliance', 'quality standards', and 'solution-oriented' to make your application stand out.
Wie du dich auf ein Vorstellungsgespräch bei CTC Resourcing Solutions vorbereitest
✨Know Your Batch Records
Make sure you are familiar with the types of Batch Records you'll be reviewing. Understand the key components like cleaning logs, production documentation, and calibration records. This knowledge will help you answer questions confidently and demonstrate your expertise.
✨Highlight Your GMP Experience
Since previous experience in GDP and GMP regulated environments is a plus, be prepared to discuss your relevant background. Share specific examples of how you've ensured compliance and addressed non-conformities in past roles.
✨Showcase Your Communication Skills
Effective communication is crucial for this role. Be ready to explain how you've interacted with various teams in the past, especially when clarifying comments or collaborating on deviations. Highlight any experiences that showcase your ability to work well in a team.
✨Demonstrate Problem-Solving Abilities
The role requires a solution-oriented mindset. Prepare to discuss situations where you've identified gaps in quality standards and how you approached resolving them. This will show your proactive attitude and ability to handle challenges.
