QA Regulatory Compliance Officer
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 to the Quality Assurance Regulatory Compliance Coordinator.**
Boehringer Ingelheim's site in Koropi, Greece, is a vital facility dedicated to the production of high-quality pharmaceutical products. Established in a strategic location near Athens, the Koropi site has played a significant role in the company's global operations, focusing on manufacturing, and distribution. Over the last year the facility is committed to innovation and excellence for human pharmaceuticals. Boehringer Ingelheim Koropi upholds the highest standards of safety, quality, security and environmental stewardship, aligning with the company's global priorities.
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**
+ Prepare CMC documentation packages for regulatory submissions worldwide.
+ Issuance and follow up of change control for proposed changes relative to local manufacturing site.
+ Manage product renewals and respond to deficiency letters from Health Authorities.
+ Support business partners on QA and regulatory matters.
+ Compilation of GMP documentation packages for site accreditations.
**WHAT YOU SHOULD BRING TO THE TEAM**
+ University degree or equivalent in Chemistry, Pharmacy, Chemical Engineering, or a related field.
+ Minimum 2 years’ experience in a Quality function within the pharmaceutical industry, ideally in a manufacturing environment; experience as a Quality Control Analyst is considered an asset.
+ Strong interpersonal and communication skills, organizational skills, critical thinking, and ability to prioritize tasks to meet deadlines with a sense of urgency.
+ Strong MS Office skills and solid familiarity with GMP‑related documentation practices.
+ Excellent command of **Greek and English** , both written and spoken.
+ Experience with SAP and/or other computerized systems (e.g., Trackwise) is considered an asset.
**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.
We kindly ask you to submit your **CV in English** . **Application deadline is February 27th.**
**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!
**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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