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Quality Assurance/Regulatory Compliance Officer

2+ years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance/Regulatory Compliance Officer

Job ID: 17628
Location: Koropi, Greece


About Boehringer Ingelheim

Boehringer Ingelheim is a research-driven pharmaceutical company with a long-standing commitment to improving lives. Founded in 1885, we are a family-owned company with over 52,000 employees worldwide. We focus on breakthrough therapies for human health, animal health, and biopharmaceutical production. Our diverse and inclusive culture fosters innovation, and we are dedicated to making a positive impact through our work.


The Opportunity

We are seeking a highly motivated and detail-oriented Quality Assurance/Regulatory Compliance Officer to join our team at Boehringer Ingelheim’s innovative manufacturing plant in Koropi, Greece. In this role, you will be responsible for ensuring compliance of product dossiers with Health Authorities’ requirements and regulatory guidelines, as well as completing Quality Assurance (QA) activities in accordance with current Good Manufacturing Practices (cGMPs), Data Integrity, and company priorities.


Your Key Responsibilities

  • Prepare CMC Documentation: Prepare and manage CMC documentation for global submissions.

  • Change Control Management: Issue and follow up on change control requests for local manufacturing site changes.

  • Support Renewals & Deficiency Letters: Work on product renewals and handle deficiency letters.

  • QA and Regulatory Support: Provide support to business partners on QA and regulatory topics.

  • GMP Documentation: Compile GMP documentation for site accreditations.


What You Should Bring to the Team

  • Education: University degree or equivalent in Chemistry, Pharmacy, Chemical Engineering, or a related field.

  • Experience: At least 2 years of experience in a quality-related role within the pharmaceutical industry. Experience as a Quality Control Analyst is a benefit.

  • Skills:

    • Strong organizational skills and the ability to prioritize tasks to meet deadlines with urgency.

    • Experience with SAP and/or computerized systems (e.g., Trackwise).

    • Critical thinking and attention to detail.

  • Languages: Fluent (native) in both Greek and English.


What You Will Get in Return

  • Well-being Focused Organization: Premium access to Headspace and ongoing well-being initiatives to improve physical, emotional, mental, and spiritual health.

  • Development Opportunities: A customized development plan, access to international development programs, languages, and training.

  • Competitive Salary: Competitive compensation package, annual bonus, life insurance, and private healthcare.

  • Work Environment: A fun, diverse, and inclusive working environment.


Application Process

  • Deadline: The position will be open until December 17th, and we only accept applications in English.

  • Recruitment Contact: If you have any questions, please contact the Talent Acquisition team at: TalentAcquisitionMIDI.EU@boehringer-ingelheim.com.


Diversity & Inclusion

At Boehringer Ingelheim, we are committed to fostering an inclusive environment where diversity of gender, geography, and generation contributes to our success. We embrace the diversity of our people, their backgrounds, and experiences, and provide equal opportunities for all.


About Boehringer Ingelheim

Boehringer Ingelheim develops therapies that improve the lives of both humans and animals. With 52,000 employees worldwide, we nurture a diverse and inclusive culture. We believe innovation is limitless when we have talented and passionate people on our team.


Why Boehringer Ingelheim?

  • Growth & Collaboration: Work in an environment that values learning, innovation, and personal development.

  • Respectful Global Work Environment: Join a global community that celebrates diversity and inclusion.

  • Impact: Your work will contribute to improving lives and making a meaningful difference.

To learn more, visit: Boehringer Ingelheim Careers.

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