Job Description:
- We are seeking a QA Contractor to support our team in conducting data reviews that support source documents /NDA Module submissions. This role requires prior QA expertise working in a production site for drug substance, preferably with synthetic peptides
Responsibilities:
- Conduct review of process development and manufacturing raw data, and other types of data used to generate source documents and NDA Module submissions
- Ensure compliance with regulatory standards and internal quality requirements.
- Collaborate with cross-functional teams to address process related queries.
- Perform electronic virtual data reviews of the CMO generated data
Requirements:
- Proven experience in data reviews.
- Background in DS manufacturing / process development, process validation working in GMP environment
- Ability to critically analyze and review technical documents.
- Strong communication skills to effectively collaborate with internal and external stakeholders.
- Must be able to read/speak French and English fluently
- 5+ years of pharma experience in GMP production site for drug substance, manufacturing process focus, preferably with synthetic peptides.
Desired Qualifications:
- Prior experience in performing review of data for source documents for NDA Module submissions.
- Familiar with GMP principles
- Highly effective organizational, communication and interpersonal skills
- Flexibility to work across different time zones.
EU (Hybrid): QA Contractor (French Speaking) (235899)
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