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Head of Quality Assurance and Compliance
2 months ago
Job Title: Head of Quality Assurance Pharmaceutical
Job Summary:
Proclinical Staffing is seeking a dedicated and experienced Quality Assurance professional to lead our Quality Management System (QMS) and ensure compliance with regulatory requirements. The successful candidate will collaborate with internal departments and external contractors to maintain high standards of product quality.
Key Responsibilities:
- Develop and implement quality policies and procedures to ensure compliance with regulatory standards.
- Conduct internal and external audits to identify areas for improvement and ensure compliance.
- Prepare for and participate in regulatory inspections and audits to ensure a smooth and successful experience.
- Oversee the preparation, review, and approval of quality-related documentation, including SOPs, training records, and audit reports.
- Conduct risk assessments and implement risk mitigation strategies to minimize the risk of non-compliance.
- Manage the investigation and resolution of quality issues, including root cause analysis and corrective action plans.
- Provide training and development opportunities on QA processes to internal teams and external partners.
- Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle, from development to commercialization.
- Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
Requirements:
- Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related field.
- Minimum 5 years of experience in quality assurance within the pharmaceutical industry, with a focus on regulatory compliance.
- Proven track record of leading quality initiatives and improving compliance.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.
