Contact us at: QEservices@gmail.com
Focusing on startups and clients experiencing consent decree/warning letters.
* Catering to USA and EU clients.
* Quality Engineering, Project Management, Quality Assurance | Control, and Business Analysis in the FDA / EMEA regulated industries (i.e. Biotech : Pharma {API, Parenterals, Solid-dose}, Class 2A/2B/3 Medical Devices, IVD’s, Cosmeceutical and Neutraceuticals).
* Focused on and experienced with computerized systems, lab & manufacturing equipment, lab instruments and systems, process, facility | utility, test methods, and cleaning validations.
* Development of SDLC documentation and deliverables per ISPE GAMP5 Waterfall and Agile SCRUM methodology.
* Performing DOE’s, gage R&R feasibility studies, system suitability, engineering studies, applying 6sigma principles.
* Conducting audits, generating & conducting CAPA | IR | DR | OOS | OOT and resolving challenges by applying risk management tools.
* Providing detailed & executive summaries, developing: project charters, project plans, master validation plans, progress metrics, final reports, and presenting recommendations.
* Managing project budget, hiring/training employees, resolving issues/conflict, prioritizing project resources based on risk, business & effectiveness.
* Providing team building, consulting, and training with respect to validation methodology, compliance, regulations, and quality engineering.
Company Details
- Employees
- 2
- Founded
- -
- Address
- 13 Lassen, Irvine,california 92612,united States
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- https://qeservices.weebly.com/
- Keywords
- Validations, Quality Engineering, Compliance, Quality Assurance, SDLC, GAMP5, Medical Devices, Biotech, Pharmaceuticals, API, 6-sigma, Parenterals, Biologics, DOE, Process Capability, ISO 13485, cGMP, QSR 21 CFR Part 820, 21 CFR Part 211 cGMP, Computerized System Validations.
- HQ
- Irvine, California
Cl Tech Inc. Questions
Cl Tech Inc.'s website is https://qeservices.weebly.com/
Cl Tech Inc.'s LinkedIn profile is https://www.linkedin.com/company/cltechinc
Cl Tech Inc. has
2 employees.
View email and phone details for 2
employees at Cl Tech Inc..
Cl Tech Inc.'s industry is
Biotechnology Research
Cl Tech Inc.'s categories are Biotechnology Research
Cl Tech Inc.'s founding year is 2003
