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Job Title: Head of Quality Assurance - Pharmaceutical Industry
The Head of Quality Assurance in the pharmaceutical industry is a leadership role responsible for ensuring that all products meet regulatory requirements, industry standards, and internal quality standards. This position plays a crucial role in maintaining and improving the quality management system within the organization. The individual in this role will lead a team of quality professionals, develop and implement quality assurance strategies, and collaborate with cross-functional teams to drive continuous improvement in product quality and compliance.
- Leadership and Team Management:
- Provide strategic leadership to the Quality Assurance (QA) team, ensuring a high level of engagement, motivation, and professional development.
- Build and maintain a high-performance culture within the QA department.
- Foster collaboration and effective communication within the QA team and with other departments.
- Quality Management System (QMS) Development:
- Establish, implement, and maintain the QMS in accordance with regulatory requirements and industry best practices.
- Ensure that the QMS is continuously improved and aligned with organizational goals.
- Regulatory Compliance:
- Stay current with applicable regulatory requirements and industry standards, and ensure the organization's compliance.
- Interact with regulatory authorities and participate in regulatory inspections.
- Quality Audits and Inspections:
- Plan and execute internal and external quality audits to assess compliance with regulatory requirements and company standards.
- Prepare and lead the organization through regulatory inspections.
- Risk Management:
- Implement and oversee a risk management program to identify and mitigate quality risks across the organization.
- Document Control and Training:
- Establish and maintain document control processes to ensure the accuracy and accessibility of quality documentation.
- Develop and oversee training programs to ensure that personnel are adequately trained on quality processes and procedures.
- Supplier and Vendor Management:
- Establish and maintain processes for evaluating and monitoring suppliers and vendors to ensure the quality of incoming materials and services.
- Continuous Improvement:
- Drive a culture of continuous improvement, utilizing quality metrics and key performance indicators to identify and implement opportunities for enhancing product quality and operational efficiency.
Qualifications and Experience:
- Bachelor's or advanced degree in a relevant scientific or engineering discipline.
- Extensive experience in quality assurance within the pharmaceutical industry, including leadership roles.
- In-depth knowledge of regulatory requirements, such as FDA, EMA, and other relevant authorities.
- Strong understanding of GMP (Good Manufacturing Practice) principles.
- Excellent leadership, communication, and interpersonal skills.
- Experience in managing and leading teams.
- Familiarity with quality management tools and methodologies.
Additional information: Candidates who meet the above conditions can send their CVs to email: [најави се за да го видиш е-маилот]