Project Manager Medical Device

August **, ****

Dear Recruiter:

My resume is attached for your evaluation. I have a B.S. in Chemistry and I’m ASQ Certified as a

Quality Auditor (CQA), Certified Quality Engineer (CQE) and Certified Pharmaceutical GMP

Professional (CPGP). I have over 17 years experience in pharmaceutical and medical device industry

with expertise in quality and manufacturing of oral dosage, parenteral products and Class II and Class III

medical devices. Thorough experience performing, reviewing and approving non conformance

investigations, CAPA’s, complaints and OOS investigations. I have a strong experience performing audits,

including supplier audits and actively participated in regulatory body audits, as Lead Investigator and

Material Quality Subject Matter Expert (SME). I have strong experience performing and approving

qualification and validation protocols and proven experience as a Project Manager. Experience in

validation includes, laboratory equipment (Chemistry/Microbiology), utilities, HVAC, clean rooms,

environmental chambers, sterilizers, cleaning validation, methods transfer among others. I have

excellent communication skills, leadership qualities and demonstrated pro-active work style with

excellent computer literacy, SAP, Trackwise, AS400 and MFG Pro among others.

Thank you for your time and for review my qualifications. Please, do not hesitate to contact me if you

have any questions, email: *******.********@*****.*** or by phone 252-***-****.

Regards,

Maribel Escalera-Galiano

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