Auf einen Blick
- Aufgaben: Be the quality guru for our pharmaceutical products, ensuring top-notch standards.
- Arbeitgeber: Join EMCM, a dynamic and internationally active company in the pharmaceutical industry.
- Mitarbeitervorteile: Enjoy flexible hours, competitive salary, holiday allowance, profit share, and sports contribution.
- Warum dieser Job: Make an impact in quality assurance while working in a supportive and innovative environment.
- Gewünschte Qualifikationen: Bachelor or Master degree with 5 years of GMP experience; fluent in Dutch and English.
- Andere Informationen: Full-time position with options for 32 or 36 hours; join us in shaping quality!
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
Do you have an eye for quality, are you communicatively strong and do you have a passion for the pharmaceutical industry? Then EMCM is looking for you!
Your tasks and responsibilities:
- 'Quality point of contact' for our CMO customer related to the product group assigned to you.
- Responsible for batch review and product release for the specific product group.
- Review of deviations, change controls, CAPA's and complaints.
- Review of relevant qualification and validation documentation.
- Participate in and support internal and external (customer) audits (on/off site).
- Represent QA in project teams and ensure that relevant quality criteria are secured at an early stage.
- Contribute to improvement projects and the further development of a LEAN QMS.
We ask:
- Bachelor or Master educational background.
- At least 5 years of relevant work experience in a GMP environment.
- Knowledge of quality systems and relevant regulations including ISO 13485:2016 and MDD/MDR.
- Excellent oral and written skills in Dutch and English language.
- Excellent analytical ability and helicopter view.
- Proactive, pragmatic and good persuasion skills.
We offer:
We offer you a responsible position within a dynamic, versatile and internationally active company. It's a fulltime position (40 hours), 32 or 36 hours can be discussed. You will receive a competitive salary and extra benefits like flexible working times, holiday allowance, profit share, a favorable pension plan and EMCM will contribute in your sport contribution.
Quality Assurance/Release Officer Arbeitgeber: Emcm B.v.
Kontaktperson:
Emcm B.v. HR Team
hr@emcm.com
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Quality Assurance/Release Officer
✨Tip Number 1
Familiarize yourself with the specific quality systems and regulations mentioned in the job description, such as ISO 13485:2016 and MDD/MDR. This knowledge will not only help you stand out but also demonstrate your commitment to the role.
✨Tip Number 2
Highlight your experience in a GMP environment during any discussions or interviews. Be prepared to share specific examples of how you've handled batch reviews, product releases, and audits in your previous roles.
✨Tip Number 3
Showcase your communication skills by preparing to discuss how you've effectively collaborated with project teams and customers in the past. Being able to articulate your experiences will be key in demonstrating your fit for the position.
✨Tip Number 4
Research EMCM's current projects and initiatives related to quality assurance and LEAN QMS. This will allow you to engage in meaningful conversations during the interview and show that you're genuinely interested in contributing to their goals.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Quality Assurance/Release Officer
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Quality Assurance/Release Officer. Highlight your relevant experience in batch review, product release, and quality systems in your application.
Tailor Your CV: Customize your CV to reflect your experience in a GMP environment and your knowledge of ISO 13485:2016 and MDD/MDR regulations. Use specific examples that demonstrate your analytical abilities and communication skills.
Craft a Strong Motivation Letter: Write a motivation letter that showcases your passion for the pharmaceutical industry and your proactive approach. Mention how your skills align with EMCM's needs and your enthusiasm for contributing to improvement projects.
Proofread Your Application: Before submitting, carefully proofread your CV and motivation letter for any errors. Ensure that your documents are clear, concise, and professionally formatted to make a strong impression.
Wie du dich auf ein Vorstellungsgespräch bei Emcm B.v. vorbereitest
✨Show Your Passion for Quality
Make sure to express your enthusiasm for quality assurance and the pharmaceutical industry. Share specific examples from your past experiences that highlight your commitment to maintaining high standards.
✨Demonstrate Your Analytical Skills
Prepare to discuss how you approach problem-solving and analysis in a GMP environment. Be ready to provide examples of how you've successfully handled deviations, change controls, or CAPAs in previous roles.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly. Be prepared to explain complex quality concepts in simple terms, as you may need to communicate with various stakeholders.
✨Familiarize Yourself with Relevant Regulations
Brush up on ISO 13485:2016 and MDD/MDR regulations before the interview. Being knowledgeable about these standards will demonstrate your readiness for the role and your understanding of the regulatory landscape.