Quality Assurance Manager - Pharmaceutical
Kelly Services is currently recruiting for a Quality Assurance Manager for a pharmaceutical company located in Austin, TX. This role will provide quality oversight of manufacturing and laboratory operations at the Austin, TX sites. The QA Manager will also work collaboratively with site leadership, quality control group at the site and quality personnel at company’s other sites. This position is responsible for assuring adherence to healthcare regulatory agency regulations, such as US FDA, and will promote a compliance culture.
- Provide quality oversight to all aspects of the manufacturing activities involving API and finished dosage form manufacturing
- Execution and maintenance of the self-inspection program
- Promote a high level of cGMP awareness and compliance.
- Provide QA oversight and guidance for the development and implementation of SOP's
- Approve GMP documentation, including SOP’s, validation documentation, change controls and other controlled documents from business partner areas.
- Write Standard Operating Procedures pertaining to Quality Assurance and cGMP systems.
- Perform internal assessments to measure compliance with appropriate Quality Assurance policies and procedures.
- Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
- Lead interactions with regulatory agency during inspections and facilitate audit response to regulatory agencies.
- Work with corporate QA group for batch release activities.
- Develop and deliver cGMP training to employees at the TX site.
- Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, consider quality policies as part of control document approval
- Bachelor of Science in Chemistry or related field; Life Science degree preferred
- 5-7 years of related experience in the pharmaceutical industry is required
- Strong GMP knowledge; Familiarity with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines.
- Experience required in Regulatory/Quality Assurance project management; supervisory management experience preferred.
- Superior communication, leadership, project management, negotiation, impact/influence, and presentation skills are essential.
- Ability to establish sound positive working relationships and interact with different types of people on all levels of skill, background and position are essential.
- Direct Hire with Full-Line of Benefits
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Product Quality Assurance