QA Systems and Validation Expert
2 weeks ago
**Job Overview:**
We are seeking a QA Systems and Validation Specialist to join our team for a 12-month contract. The successful candidate will be responsible for ensuring the quality of our systems and processes, ensuring compliance with regulatory requirements, and providing expertise in validation.
Main Responsibilities:
- Assessment of changes for GMP compliance in accordance with site change control procedure.
- Review and approval of GMP design aspects of major capital projects including new facility construction, facilities upgrade, and equipment installation.
- Ensuring all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, and 21 CFR standards.
- Providing expertise in validation ensuring compliance with current industry regulations and guidelines.
Requirements:
- Minimum of BSc/BEng in Chemistry, Engineering, or a science-related discipline.
- At least 3 years' experience in a pharmaceutical company, preferably in a QA role.
- Knowledge of relevant process validation/cleaning validation/automation is an advantage.
- Strong interpersonal, communication, and presentation skills required.
Key Skills:
- Quality Management System (QMS)
- Validation and Qualification
- GMP Compliance
- Change Control
- Data Integrity
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