Description
POSITION SUMMARY:- This position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities including maintenance of quality systems ensuring compliance to cGMPs, 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.
- Additionally, this position will author and distribute notifications outside of SLS regarding Out of Specification/Questionable testing results.
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, policies, site procedures and regulatory guidance.
- 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.
- Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed time frames.
- Support the development of SLS right first time initiatives, SQRT presentations and procedures along with the communication of associated quality metrics.
Qualifications:
- Bachelor's degree in Chemistry/Microbiology or related discipline or equivalent
- Experience: 3-5 Years of related experience
- Self-motivated,
- Team player,
- Deadline driven
- Effective Communicator - both oral and written,
- Strong understanding of GMP requirements and
- Good Understanding of Analytical Techniques