Maria P. Email & Phone Number

Durham, North Carolina, United States

Program Manager for global biopharmaceutical projects including cell line development, process development, analytical development, and cGMP manufacturing. Provide leadership for cross- functional teams, create/track metrics, execute contract deliverables, and facilitate project meetings. Responsibilities include revenue forecasting, risk management.

Wilson North Carolina

 Provide Quality Assurance oversight of Manufacturing and Quality Control areas.  Provide QA review and approval of new and existing procedures, investigation documentation, and process controlDocuments. Use trend and investigational data to create value through process improvements and failure reduction activities. Identified failure modes and related.

Toronto, Canada Area

 Generating and executing IOQ protocols for compounding equipment such Symex automated and non-automated 65L, 300L, 500L and 1000 L, for Estée Lauder for new over the counter (OTC) cosmetic products. Responsible for communications to management & other Units in Canada and USA.

Melville, NY And Toronto, Canada

Addressing immediate corrective actions to FDA-483 observations. Provide Project Management and quality oversight to new and /or JR validation staff on identifying and understanding the resources need it to develop and execute protocols.Generating and executing IOQ and PQ protocols for compounding equipment, filling Lines, DI system for Estée Lauder and.

Raleigh-Durham, North Carolina Area

Experienced professional with extensive experience in a variety of technical positions: As CAPA Remediation, FDA Remediation's, investigations and deviations liaison, change control coordinator, auditor, validation project manager, validation project leader, and lab manager. Specific areas of expertise are in Quality Systems, CAPAs, Change Control.

Marion NC

CAPA REMEDIATION.➢ Performed the role and responsibilities as a CAPA Owner, CAPA Investigation Owner and CAPA Quality Reviewer as corrective actions for FDA 483 observations➢ Help in the reduction of Back log of CAPA’S open➢ Provide quality oversight with respect to investigations and coach Baxter personnel involved in writing CAPA’s with identifying.

Fougera (Nycomed US) Hicksville And Melville, NY

Addressing immediate corrective actions to FDA-483 observations. Member of a team performing filling lines qualification assessments to evaluate the filling lines qualifications and supporting performance documentation associated with the lines against current FDA and Fougera pharmaceuticals (Nycomed US) equipment and process qualification/ validation.

Downingtown, PA

Philadelphia, PA

Charlotte, North Carolina, United States