Description
This position will primarily support Quality Assurance activities including maintenance of quality systems ensuring compliance to cGMPs, company policies, site procedures and regulatory guidance. These systems include laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, corrective and preventive actions (CAPAs) and change management.ESSENTIAL FUNCTIONS:
- Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) laboratory investigation reports, deviation reports, analytical method validation and transfer reports, change control documentation, certificate of results, laboratory instrument qualification/calibration and quality alerts according to procedure requirements.
- Ensure site quality systems are consistent with cGMPs, company policies, site procedures and regulatory guidance.
- Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed time frames.
- Support the development of first time initiatives, presentations and procedures along with the communication of associated quality metrics.
Education: Bachelor's degree in Chemistry/Microbiology or related discipline or equivalent
- Experience: 3-5 Years of related experience
- 4-7 years of experience with Good Manufacturing Practices (GMP)
- Able to apply relevant analytical/experience to solve technical problems in order to partner with the laboratories to identify root cause
- Familiarity with the principles and application of quality risk management.