Quality Assurance Specialist
il y a 2 semaines
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.
Responsibilities:
- Monitor and oversee quality control procedures to ensure raw materials, intermediate, and finished products meet specified quality standards.
- Collaborate with the Quality Control department to address any quality issues or deviations.
- Ensure that all manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
- Maintain up-to-date knowledge of regulatory changes and ensure the organization's practices are aligned with these changes.
- Manage and maintain comprehensive documentation for all quality assurance activities, including batch records, deviations, CAPA (Corrective and Preventive Actions), and change controls.
- Review and approve Standard Operating Procedures (SOPs) related to quality assurance and manufacturing processes.
- Conduct regular risk assessments of manufacturing processes 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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