Quality Assurance/Regulatory Compliance Officer (maternity cover)
Boehringer Ingelheim
**WHO ARE WE?**
ROPU MIDI is a Regional Operating Unit that covers all local Human Pharma and Animal Health Operating Units across Belgium, Denmark, Norway, Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI has a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.
**THE OPPORTUNITY**
We are seeking a highly motivated and detail-oriented Quality Assurance/Regulatory Compliance Officer to join our team at Greece’s most innovative manufacturing plant. In this role, you will be responsible for ensuring compliance of product dossiers with Health Authorities requirements and regulatory guidelines, while also ensuring the completion of Quality Assurance (QA) activities according to cGMPs, Data Integrity, and company priorities.
This position is based in Koropi (Greece) and reports directly to the Quality Assurance Regulatory Compliance Manager.
This is a fantastic opportunity for an experienced professional who wants to be part of a truly innovative and revolutionary team! Join us if you want to make the difference.
**YOUR KEY RESPONSIBILITIES**
+ Preparation of CMC Documentation for submissions worldwide.
+ Issuance and follow up of change control for proposed changes relative to local manufacturing site.
+ Work on product renewals and deficiency letters.
+ Support business partners in QA and regulatory topics.
+ Compilation of GMP documentation packages for site accreditations.
Please note: this position will be posted until the 14th of February, and we only accept applications in English.
**WHAT YOU SHOULD BRING TO THE TEAM**
+ University degree or equivalent in Chemistry, Pharmacy, Chemical Engineering, or a related field.
+ At least 2 years of working experience in quality within the pharmaceutical industry.
+ Work experience as a Quality Control Analyst is a benefit.
+ Strong organizational skills, critical thinking, and ability to prioritize tasks to meet deadlines with a sense of urgency.
+ Experience with SAP and/or other computerized systems (e.g., Trackwise).
+ Fluent (native) in both Greek and English.
**WHAT WILL YOU GET IN RETURN?**
Next to the opportunity to develop and challenge yourself while learning from a fast-paced environment:
+ Work in a wellbeing-oriented organization (Premium access to Headspace and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being)
+ Customized Development plan based on your role and aspirations, and access to international development opportunities and languages + training programs.
+ Competitive salary (plus annual bonus, participation in company life insurance and private healthcare program)
+ A fun and diverse working environment.
**What’s next?**
We will have a look at your CV and cover letter. If we see a match, we will invite you for a video call interview to get to know each other. We will keep you posted during the process!
If you have any questions related to the recruitment process, please do not hesitate to contact Talent Acquisition MIDI: TalentAcquisitionMIDI.EU@boehringer-ingelheim.com
**DIVERSITY & INCLUSION**
At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company – diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone! We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Screening:
In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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