
Lead QA Specialist for GMP Compliance
4 days ago
Position Overview
We are looking for an experienced Lead QA Specialist for GMP Compliance to join our team. As a key contributor, you will be responsible for ensuring compliance with GMP guidelines and regulatory requirements.
Key Responsibilities:
- Develop and implement quality systems for analytical activities, including stability studies.
- Collaborate with cross-functional teams to ensure effective analytical support.
- Manage analytical method validations, tech transfers, and stability studies.
- Liaise with Global Regulatory Affairs/CMC on analytical quality issues.
- Author, review, and approve SOPs and related documentation.
Qualifications:
- University degree (min. 4 years) in Chemistry, Biology, Biotechnology, or related field.
- 10+ years of QA experience in analytical science within a GMP environment.
- Strong understanding of regulatory guidelines, method validation, and product specifications.
- Proven experience managing deviations, CAPAs, and interactions with external stakeholders.
- Broad knowledge of analytical chemistry and bioassays.
- Fluent in English (written and spoken).
About Our Company Culture
We are a collaborative and dynamic organization that values work-life balance and recognizes its importance in driving employee satisfaction and productivity.
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