Oscar Reyes
Plant Operations Manager at Solara Labs
- Role
- Operations Manager at Aenova Group
- Location
- Miami, FL, US
- LinkedIn followers
- 500 followers
About Oscar Reyes
Performance and Result driven Pharmaceutical Industry Professional with 20+ years of…
Experience
Operations Manager
May 2015 — Present · Miami, FL, US
Responsible for managing high velocity manufacturing processes consisting of 30 employees on a 3 shift operation. Ensure compliance to demanding standards of external regulatory agencies including FDA, OSHA and customer audits. Support site in implementing safety guidelines for manufacturing. Schedule work centers and ensure that manufacturing metrics are attained. Responsible for ensuring all MFG Employee training (GMPs, SOPs and Safety). Maintain area documentation by revising/creating SOPs/Forms and batch records. Purchase and implement manufacturing supplies and equipment with a cost saving and rapid implementation mind set. Responsible for completing investigation reports and CAPA’s in a timely manner through data collection and analysis. Support IQ / OQ of new manufacturing equipment and process validation. Led process validations in order to continue business growth while meeting daily customer commitments. Implemented a second and third shift per business / customer demands and increased manufacturing output from 21mil SDU\'s/day. Successfully triple output of the sites highest volume product through effective equipment utilization and personnel training. Represented manufacturing in successful FDA and Customer audits.
Education
Albany College of Pharmacy and Health Sciences
Bachelors, science and psychology
1988 — 2001
Skills
- Cqa
- Quality Management
- Validation
- Building Strong Teams
- Design Control
- Six Sigma
- Gxp
- Equipment Qualification
- Quality Auditing
- Aseptic Processing
- Pharmaceutics
- Medical Devices
- Capa
- Quality System
- V&V
- Technology Transfer
- Regulatory Submissions
- Trackwise
- Leadership
- Delivering Results
- Cgmp Practices
- Calibration
- Fda Gmp
- Lims
- Contract Manufacturing
- Manufacturing
- Sterilization
- Cleaning Validation
- Change Control
- Root Cause Analysis
- Attention to Detail
- Computer System Validation
- Quality Assurance
- Ich Guidelines
- Cross-Functional Team Leadership
- Iso 14971
- Biopharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
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