Vanessa Sanchez
Caguas,P.R.
Summary
To apply my knowledge and experience to satisfy the needs of the company and exceed the established standards. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives. Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines.
Overview
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1
Certification
Work History
Senior PQA
Amgen Manufacturing Limited
Juncos, P.R.
- Experience in the medical device or biotechnology industry.
- Good Investigation Skill & Quality Management System.
- Deviation and CAPA Overview & Batch Production Records (EBR) Review & Approval.
- Global Regulatory Expectations / Good Distribution Practices.
- Operational Excellence Overview / Analytical Testing, Audits Inspections. - Disposition: Quality Disposition. Strengthen Organization Capabilities. Reducing the BRR of Inspected DP to as part of the Segmentation Packaging Project.
- Project Management. Audits logbooks documentation and BRR offline and online. - Deliver on timelines of the HMLV project.
- Resource to review/approve protocols, reports, CC, Deviations, and procedures. - Use of available DAI tools and seek coaching. Strengthen Organization Capabilities.
- Support to special QA tasks such as samplings, inspections and training to new associates.
- Experience in electronic systems such as: Maximo, Trackwise and LIMS, BTRS , CDOcs
- Document Management System author, reviewer, approver.
- Expiration dating approver following product / jurisdiction by specification. - Guidance to Production staff regarding compliance with SOP and Work Instructions.
- - Approval of PVlist, PMBR, MBR and GMBR / (MES) system & - Designer MES system training.
- Support to Advance Operational Excellence and Lean Transformation Results.
- Use of OE tools. Perform Quality Oversight. Strengthen Organization Capabilities.
- NPI process and management. Support NPI and commercial process changes.
- EDM Quality Documents QA reviews and approvals.
- Changes Evaluation Request (CER) assessment.
- Participate in Process improvement, FMEA, Root Cause Analysis and Risk Assessment.
- SAP Quality transactions. - Coordinator, analysis and approval volume samples in LIMS.
- Support as QA during filling and formulation BRR process. - MES designer training and approval
- Deviations and CAPA. - Strengthen Organization Capabilities.
- Perform revisions and approvals on SOPs.
- Chief Sentinel of Security program.
- -Participate in Supply Chain Triage & CAPA Applicability Forum.
- Worked effectively in fast-paced environments.
- Self-motivated, with a strong sense of personal responsibility.
- Worked well in a team setting, providing support and guidance.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
Education
MBA - Project Management / MBA in Management Supervisor and Leadership
Turabo University
Gurabo, P.R.06-2018
Skills
- Biotechnology expertise
- Collaborative teamwork
- Customer engagement
- Strategic issue analysis
- Effective multitasking
- Effective multitasking
- Proficient in computer applications
- Strong organizational abilities
- Analytical reasoning
Accomplishments
- Collaborated with team of 5 in the development of [Segmentation , Autoinjector, MES and Imdelltra].
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Certification
PMP, Microsoft Project, Info Mapping Certification, CQA (Quality Risk Management training) Investigation System CAPA Expert Certification, Data Integrity training and PMP. PMPR and (Quality Risk Management training).
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
Senior PQA
Amgen Manufacturing Limited
MBA - Project Management / MBA in Management Supervisor and Leadership
Turabo University
CHARACTERISTICS
Extremely dedicated, accountable, team worker, responsible, committed, and passionate towards the field of Quality and/or Management. Work effectively under pressure.