Olger Q.
Senior Quality Assurance Specialist, PharmD with over 15 years of experience in the pharmaceutical industry.
- Role
- Sr Quality Assurance (Qa) Batch Disposition at MilliporeSigma
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Olger Q.
Versatile, highly accomplished PharmD with over 15 years of experience in the pharmaceutical industry; with a distinguished and diversified career in quality assurance, batch disposition, complaints, deviations, process improvement, use and interpretation of procedures and standards, logistics, GMP, Clinical Trials (CT) drug product, CMO, and support of regulatory activities for pharmaceutical products.
Experience
Sr Quality Assurance (Qa) Batch Disposition
Oct 2020 — Present
Fully cross-trained and responsible for reviews of all types of documentation reviewed/approved by QA Product Release group, including raw materials, all types of in-process and finished batch records, laboratory and environmental results, shipping documentation, temperature data reviews, and LIRs/NC/Deviations.• Ensures that all documents reviewed are in accordance with GMP and company requirements.• Acts as a subject matter expert for other QA Compliance Associates, QA Inspectors, and individuals outside of the department. • Participates as QA representative in interdepartmental teams and projects, as assigned.• Trains new departmental employees.• Maintains and presents QA-PR data and reports on applicable departmental metrics.• Provides needed QA information in answer to customer requests and for annual product quality reviews.• Provides suggestions for improvements in QA procedures and processes.• Performs special projects and other duties.
Education
Universidad de Costa Rica UCR
Doctor of Pharmacy (PharmD), Pharmacy
Skills
- Customer Service
- Drug Safety
- Medical Devices
- Lifesciences
- Training
- Healthcare
- Drug Development
- CRO
- Regulatory Affairs
- Diabetes
- Pharmaceutical Industry
- Spanish
- Fda
- Ctms
- Oncology
- Strategy
- Clinical Trials
- Therapeutic Areas
- Gmp
- Clinical Research
- Leadership
- Cross-Functional Team Leadership
- Pharmaceutical Sales
- Biotechnology
- Pharmacovigilance
- Contact Centers
- Quality Assurance
- Quality Auditing
- Labeling Development
- Printed Packaging Materials
- Deviations
- Capas
- Medical Information
- Latin America
- Technical Support
- Public Relations
- Brand Management
- Enterprise Marketing
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