Quality Assurance/Regulatory Compliance Officer (Maternity Cover)

2+ years

Not Disclosed

Greece Koropi Remote

10 Feb. 13, 2025

Job Description

Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 (Maternity Cover)

Job ID: 17628
Location: Koropi, Greece
Job Function: Quality, Regulatory Affairs
Career Level: Experienced Professionals
Working Time: Full-Time
Job Flexibility: Hybrid

Position Overview

We are seeking a highly motivated Quality Assurance/Regulatory Compliance Officer for a maternity cover position based at Greece’s most innovative manufacturing plant in Koropi. In this role, you will ensure the compliance of product dossiers with Health Authorities' requirements and regulatory guidelines, while also overseeing the completion of Quality Assurance (QA) activities according to cGMPs, Data Integrity, and company priorities.

This is an exciting opportunity to join a multicultural and innovative team within a dynamic environment.

Key Responsibilities

CMC Documentation:
- Prepare CMC documentation for global submissions to regulatory authorities.
Change Control:
- Issue and follow up on change controls related to local manufacturing processes.
Product Renewals & Deficiency Letters:
- Work on product renewals and address deficiency letters from regulatory authorities.
QA and Regulatory Support:
- Support business partners in both Quality Assurance and regulatory compliance matters.
GMP Documentation:
- Compile GMP documentation packages for site accreditations.

Qualifications & Requirements

Education:
- University degree or equivalent in Chemistry, Pharmacy, Chemical Engineering, or related field.
Experience:
- At least 2 years of working experience in Quality Assurance within the pharmaceutical industry.
- Experience as a Quality Control Analyst is a plus.
Skills:
- Strong organizational skills, critical thinking, and the ability to prioritize tasks to meet deadlines.
- Experience with SAP or other computerized systems (e.g., Trackwise) is preferred.
Language Skills:
- Fluent in both Greek and English.

What Will You Get in Return?

Work-Life Balance:
- Access to wellbeing initiatives including premium access to Headspace.
Development Opportunities:
- Customized development plans based on your role and aspirations, with access to international training and language programs.
Competitive Compensation:
- Competitive salary with an annual bonus, life insurance, and a private healthcare program.
Diverse Work Environment:
- A fun, multicultural, and inclusive working environment.

Application Process

Deadline: The position will be posted until 14th February.
Language Requirement: Applications should be submitted in English.

If your profile matches our requirements, we will invite you for a video call interview. For any inquiries about the recruitment process, you can contact Talent Acquisition MIDI at TalentAcquisitionMIDI.EU@boehringer-ingelheim.com.

About Boehringer Ingelheim

Boehringer Ingelheim is a family-owned company founded in 1885. We are dedicated to innovative therapies for humans and animals. With over 52,000 employees globally, we offer a diverse, collaborative, and inclusive work culture. Our goal is to create breakthroughs that improve lives and health.

Boehringer Ingelheim is an equal opportunity employer that values diversity and inclusion. We respect and celebrate the diverse backgrounds and experiences of all our employees, and we are committed to creating an inclusive work environment.

For more information, visit Boehringer Ingelheim.

Ready to apply?
Click the “Apply Now” button and submit your application.

Additional Information

Boehringer Ingelheim is an equal opportunity employer that embraces diversity in its workforce and strives for an inclusive environment.

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Quality Assurance/Regulatory Compliance Officer (Maternity Cover)

Job Description

Job Title: Quality Assurance/Regulatory Compliance Officer (Maternity Cover)

Position Overview

Key Responsibilities

Qualifications & Requirements

What Will You Get in Return?

Application Process

About Boehringer Ingelheim

Additional Information

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