GMP Quality Assurance Specialist
1 week ago
Job Title: Head of Quality Assurance Pharmaceutical
Job Summary:
Proclinical Staffing is seeking a dedicated and experienced Quality Assurance professional to join our team as a Head of Quality Assurance Pharmaceutical. This role is pivotal in ensuring the safety and quality of pharmaceutical products, as well as ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Participate in the maintenance of the Quality Management System (QMS) in compliance with regulatory standards, including ISO 9001 and FDA regulations.
- Conduct internal and external audits, as well as participate in regulatory inspections, to ensure compliance with industry standards and regulatory requirements.
- Prepare for and participate in regulatory inspections and audits, ensuring that all necessary documentation and records are up-to-date and compliant.
- Oversee the preparation, review, and approval of quality-related documentation, including SOPs, protocols, and reports.
- Conduct risk assessments and implement risk mitigation strategies to ensure the quality and safety of pharmaceutical products.
- Manage the investigation and resolution of quality issues, including deviations, non-conformities, and CAPAs.
- Provide training and development opportunities on QA processes to the company, ensuring that all employees understand their roles and responsibilities in ensuring quality and compliance.
- 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, resulting in cost savings and improved customer satisfaction.
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 strong understanding of regulatory requirements and industry standards.
- Proven track record of ensuring compliance with regulatory requirements and industry standards, with a strong focus on quality and safety.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.
- Ability to manage multiple projects and priorities in a fast-paced environment, with a strong attention to detail and ability to meet deadlines.
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