Clinical Manufacturing Quality Manager
il y a 2 semaines
About the Job
We are seeking an experienced Pharmaceutical Quality Assurance Specialist to join our Clinical Manufacturing Quality team. The successful candidate will be responsible for ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development. This role requires strong technical knowledge in engineering, particularly in pharmaceutical production, and excellent communication skills.
Key Responsibilities:
- Ensure compliance with GMP and GSP regulations through the implementation of quality management systems and procedures.
- Develop and implement quality risk management processes to mitigate risks.
- Provide training and guidance to colleagues on cGMP/GSP and QMS requirements.
- Coordinate qualification and validation activities and regulatory inspections.
- Monitor and report on compliance and quality issues.
Requirements:
- Master's degree in a relevant field (e.g., pharmacy, biology, chemistry).
- Minimum 5 years of experience in a quality assurance or regulatory affairs role.
- Proven track record of implementing quality management systems and procedures.
- Strong understanding of GMP and GSP regulations.
- Excellent leadership and communication skills.
- Ability to work in a fast-paced environment and prioritize tasks effectively.
- Fluency in French and English.
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