Mariela Alvarez

Qms Investigator, Quality Assurance @SGS

Mississauga, ON, CA

Guides OOS results from investigations daily where SOP and regulatory guidelines are followed- Reviews and approves OOS investigations; Provides support in OOS investigations to sequence of events and root cause analysis or other techniques. Approves OOS hypothesis testing, repeat test and final OOS Investigation according to internal SOP. Decides together with operations on corrective /preventative action plans for OOS due to SGS and assures Invalidation of testing results are compliant with regulations- Participates in or leads CAPA /Complaint process. Investigates CAPAs of QA. Participates in CAPA;investigations if requested by CAPA owner or QA supervisory. Reviews and approves CAPAs according toCAPA SOP- Initiates, investigates and approves deviations according to internal SOP andregulations- Initiates/leads improvements to improve Key Performance Indicators KPIs for correctness of Co A- Manages on time CAPA process according to SGS SOP. Assures Site Specific CAPA, OOS and SOPs are aligned with global SOPs. Reviews OOS, CAPA and other SOPs as requested by Manager- Reviews stability protocols as per client requests and communicates effectively with clients if required- Performs QA Review/ approval of methods- Review validation protocols or reports of methods or equipment- Performs review of calibration records or testing records- Perform Internal audits; Follows up on corrective action- Perform corrective action for internal audits and external audits- Prepare responses to external audits reports- In case of a deviation from SOP initiates a deviation form and investigates, justifies and performs root cause analysis and corrective action- Ensure that client requests and complaints are dealt with effectively.

Universidad de Chile

Materials Science Engineering (PhD)