Senior Quality Control Professional
il y a 1 semaine
Groupe ProductLife is seeking a highly motivated Quality Assurance Specialist to oversee the quality control process, manage compliance, and conduct risk assessments within the manufacturing environment.
Key Responsibilities:
- Ensure quality control procedures are in place to meet specified quality standards.
- Collaborate with the Quality Control department to address quality issues or deviations.
- Ensure manufacturing processes adhere to cGMP and other regulatory requirements.
- Maintain up-to-date knowledge of regulatory changes.
- Manage and maintain comprehensive documentation for quality assurance activities.
- Review and approve SOPs related to quality assurance and manufacturing processes.
- Conduct regular risk assessments to identify potential quality issues.
- Implement corrective actions to mitigate identified risks and ensure product integrity.
- Provide training and guidance to production and quality control staff on quality standards, regulatory requirements, and company procedures.
- Coordinate and participate in internal and external audits and inspections.
Requirements:
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field.
- 10+ years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of cGMP, FDA/EMA regulations, and quality management systems.
- Experience with regulatory audits and inspections.
- Familiarity with electronic Quality Management Systems (eQMS).
- Strong attention to detail and excellent problem-solving skills.
- Effective communication skills, with the ability to train and influence others.
- Certification in Quality Management (e.g., Six Sigma, ISO 9001) is a plus.
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