Mujtaba Ali
- Role
- Managing Director Sr Quality and Operations Consultant Pm at Ocq Solutions
- Location
- Orange County, CA, US
- LinkedIn followers
- 500 followers
About Mujtaba Ali
M•••@OCQSolutions.com or G••••••••@gmail.com; Available for Full Time or…
Experience
Managing Director Sr Quality and Operations Consultant Pm
Jan 2017 — Present
Accomplished Quality and Operational Consulting Executive focused on deploying compliant solutions. Strong Project Management skills with a track record for deploying successful Compliance, FDA remediation, Quality Systems, Validation, Supplier Quality and Technical Operations project. Track record of results in FDA regulated industries. Well-rounded entrepreneurial management style that cultivates excellence, promotes team development, and builds dynamic relationships at all levels.* Identified gaps with BLA, Process Val, SOP and Mfg. records for a site with Warning Letter.* Led a project implementing upgraded aseptic processes for a site with warning letter * Performed site audit(s) to assess GMP readiness for Gene Therapy Facility; Aseptic Facilities; and Other.* Developed Phase appropriate Quality systems for clients.* Supporting design of Gene Therapy Facility and Process * Acting Site Quality Head and Led a PAI Readiness Project for Antibody Drug Conjugate product: Activities included updating Quality System; built Quality Assurance Organization (hired over 30 staff members); oversaw release of product manufactured at CMO and local site; provided integral support for Data Integrity / Governance process; and hosted the FDA for the PAI inspection.
Skills
- Biopharmaceuticals
- Pharmaceutical Industry
- Engineering
- Biotechnology
- Strategy
- Program Management
- Corrective and Preventive Action (Capa)
- Validation
- Change Control
- Quality System
- Fda
- Start-Ups
- Capa
- Process Simulation
- Quality Control
- Cross-Functional Team Leadership
- Quality Assurance
- Project Management
- Technology Transfer
- Lifesciences
- Gxp
- U.s. Food and Drug Administration (Fda)
- Life Sciences
- Manufacturing
- Sop
- 21 Cfr Part 11
- Gmp
- Aseptic Processing
- Continuous Improvement
- Clinical Trials
- Medical Devices
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