Vacancy caducado!
Quality Assurance ManagerActalent is seeking an experienced Quality Assurance Manager to join our team and drive excellence in quality processes for pharmaceutical and medical device manufacturing. Responsibilities:
Technical Support and Oversight: Provide comprehensive technical support and quality assurance oversight to ensure compliance with good business practices and applicable Health Authorities’ requirements.
Manufacturing and Testing: Support the manufacturing, testing, disposition, and distribution of all materials.
Product Consistency: Ensure that our products consistently meet customer and regulatory requirements.
Establish and Maintain Quality Management System: Develop, implement, and oversee the quality management system to ensure adherence to cGMP regulations and internal policies.
Regulatory Compliance: Ensure that quality management policies align with relevant regulatory agencies’ guidelines and laboratory protocols.
Batch Record Review: Collaborate with Manufacturing to review executed batch records, ensuring compliance with internal and regulatory requirements.
Product Release: Evaluate production batch records to determine compliance with cGMP regulations and approve product release.
GMP Product Labels: Review and approve labels for compliance with regulatory standards.
FDA/Regulatory Support: Assist with FDA inspections and regulatory filings as needed.
Metrics and Reporting: Collect and present performance metrics related to quality assurance.
Project Leadership: Participate in or lead project teams as a Quality representative.
Internal and External Audits: Provide support during audits.
Initiatives and Compliance: Influence and implement initiatives to improve overall compliance and maintain inspection readiness.
Protocols and Strategies: Develop, review, and approve validation, qualification, and commissioning protocols.
Integration in Project Delivery: Ensure QA department involvement from project initiation to completion.
Fast-Paced Environment: Adapt to the dynamic nature of drug and medical device development, managing work allocation and deadlines effectively.
Skills and Qualifications: (not all required)
Bachelor’s degree (BS/BA) in Life Science (Biology or Biochemistry) or equivalent.
6 years of pharmaceutical experience, including 6 years in Quality Assurance Management.
Extensive knowledge of FDA regulatory requirements and ability to apply GMP regulations.
Technical understanding of pharmaceutical manufacturing, validation, raw materials, and analytical testing.
Familiarity with 21 CFR Parts 210, 211, and 820 FDA compliance.
Audit or inspection experience preferred.
Excellent verbal and written communication skills.
Business systems analysis experience in QA.
Knowledge of cGMP regulations applicable to the U.S.A.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Vacancy caducado!