Sara Covas

Bda Singapur Arroyo, PR 787-***-**** ady410@r.postjobfree.com

Summary of Qualifications

Motivated, and experienced professional with background in various decision-making roles, including program development, quality systems, personnel training, and team coordination.

In-depth knowledge of various computer systems: SAP, Agile, Compliance Wire, VICE, MCT, Enovia, CECATS, Master Control

Skilled problem solver; able to flourish in high-pressure and fast-paced environments.

Excellent written and oral communication skills in English and Spanish

In-depth knowledge of Certificate of Foreign Government submission

In-depth knowledge Quality System Regulations and Compliance

Professional Experience

Catalent Pharma Solutions – Gaithersburg, MD Mar. 2022 – Apr. 2023

Senior Compliance Training Specialist

Principal QA

Manage the site LMS, ensuring Pre-Clinical and GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance, and efficiency.

Analyze training needs and design training and performance support deliverables, including training approach, training curriculum, training materials/content, training effectiveness assessment, and plan to ensure GMP/GDP sustainability.

Support Training CAPA (Corrective and Preventive Actions), deviations and observations.

Provide strategic oversight of the document control systems ensuring phase appropriate processes to support all Phases and commercial operations.

Manage document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as regulatory requirements.

Establish and maintain the lifecycle of controlled documents, including but not limited to records management systems including version control, document distribution, archival, retrieval, retention, and destruction.

Revision, issuance and tracking of controlled documents.

Ensure compliance to applicable regulatory requirements and standards.

Conduct internal audit of documents and system.

Professional Services – Medtronic – Juncos PR Dec. 2020 – Mar. 2022

Configuration Assurance Administrator Aug. 2016 – Feb. 2017

Responsible for monitoring configuration and documents changes management process effectiveness including the impact of changes and takes the initiative to recommend configuration and change management process improvements.

Worked with various projects: ECO Project (more than 200 changes), Olympus, CAPAs

Document changes and configurate using:

SAP, Agile, MCT, Enovia, VICE, FW IDE, Putty

SAP Accounts creation

Provide training of GMPs and Good Documentation Practices for new employees.

KLS MARTIN — Jacksonville, FL

Regulatory Affairs Specialist Aug. 2017 – Oct. 2019

Evaluate proposed products for regulatory classification in Mexico and Central American Countries.

Coordinate and prepare regulatory submissions for domestic or international projects.

Request Certificates of Foreign Government from FDA. Used CECATS for CFGs submission.

Request document authentication (notary, apostille, legalize).

Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products. License renewal, updates, and registrations.

MEDIAL GROUP

Professional Services – J&J – Guaynabo, PR

Regulatory Affairs Specialist Mar. 2017 – Aug. 2017

Evaluate proposed products for regulatory classification in Brasil, Argentina, Mexico, and Central American Countries.

Coordinate and prepare regulatory submissions for domestic or international projects.

Request document authentication (notary, apostille, legalize).

Maintain current knowledge of FDA and international regulations, guidance and standards applicable to company products. License renewal, updates, and registrations.

STRYKER PUERTO RICO, LTD. — Arroyo, PR

Change Control Specialist Sept. 2010 – Apr. 2016

Document Control / Change Control Process Jan. 2001 – Apr. 2007

Responsible for administrative roles in the document management at the site.

Review of change control documentation for procedures, forms, and specifications.

Responsible for the validation library.

Support QA Management during internal and external audits.

Supported CAPA Investigation and Deviation System.

Responsible for planning, scheduling, coordinating and administration of all change control related efforts and activities.

Interface with all levels within organization including other divisions and, outside vendors.

Responsible for auditing and maintaining change control system.

STRYKER PUERTO RICO, LTD. — Arroyo, PR

Human Resources – Training Specialist Apr. 2007 – Sep. 2010

Compliance Wire Platform Implementation.

Creation of Job Descriptions per Departments.

Responsible for the New Hire Orientation.

Played a key role to ensure the Train the Trainers Certification for the Manufacturing Leaders.

Administrative Responsibilities in the Training Management Software.

Report preparation / Training Database Update.

Training coordination – Accomplished 95% participation for Compliance training.

Liaison between Operations and Quality Departments.

Organization regarding training.

Perform Audit in the manufacturing areas to assess the level compliance with training curriculum per associate.

STRYKER PUERTO RICO, LTD. — Arroyo, PR

Group Leader Oct. 1997 – Jan. 2001

Assisted department supervisor with associates.

Increased production levels 50%.

Interviewed possible candidates.

Education

INTER AMERICAN UNIVERSITY — Guayama, PR

BA Human Resources Management (Magna cum Laude) June 2009

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