Marline Raphael Email & Phone Number

Chaguanas, Trinidad And Tobago

Develop, maintain and conduct training on standard operating procedures (SOPs).Prepare and submit documentation for product registration worldwide.Investigate, develop and write Deviation Investigation Reports.Conduct internal audit to ensure compliance with FDA regulations, cGMP as per 21 CFR, ISO, NSF and NPA requirements.Create trending report base on Internal Audit.Investigate and respond to customer complaints. Initiate and implement CAPA and NCR to complaints and nonconformities.

Supervised QA team on 2nd shift. Assigned tasks to team members. Ensured cGMP was being followed. Wrote daily, weekly and monthly reports.Reviewed and approved production batch record documents, ensuring that dietary supplements met strength, purity and composition as listed in the specification before beginning production.Created and reviewed product processing instructions and made any necessary adjustments to the formulation before releasing the batch record to production.

Lead 3 teams of 5 QA employees each in the daily activities around ensuring the qualitySupported the plants initial ISO 9001 and 14001 certification by maintaining ongoing objective evidence that all raw material test protocols were appropriately documented and regularly evaluated for adequacy and effectiveness. Developed Standard Operating Procedures for all processes that were required to ensure ongoing effectiveness and adequacy of the raw materials QA and QC procedures.Developed and delivered new member training to ensure long-term consistency of operation.