Quality - Process Improver
Weil Group
- Manatí, PR
- Permanente
- Tiempo completo
- The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting, manufacturing investigations task items, CAPA’s, Change Controls, Stand Alone Actions.
- Takes immediate action and necessary decisions on manufacturing situations
- Responsibility of identifying, recommend and implement process and equipment modifications to improve process performance and maximize processes and equipment
- Decisions may have impact on compliance and cost initiatives
- Takes action to assure the manufacturing area is in cGMP’s compliance
- Working relationship with unit’s members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
- Daily contact with site peers, management and staff to set and / or follow priorities driven by business needs.
- Regular interaction with internal / external auditors, government agencies, and other regulatory agencies or institutions.
- Works closely with Warehouse, Sterile and Non Sterile Operations Area Lead / Supervisors to improve current processes in order to optimize product efficiency/yields.
- BS Degree in Science, Pharmacy and/or Engineering
- 6+ years of experience in a Parenteral Manufacturing operation facility
- Broad working experience with Change Controls/Change actions and CAPA
- Experience with validation protocols
- Strong technical writing and presentation skills
- Ability to interpret and analyze statistical data
- Knowledge in CGMP’s, OSHA, EPA and other regulatory standards
- Knowledge of computers applications (Microsoft Word, Excel, Power Point)
- Excellent leadership and interpersonal skills
- Team work oriented
- Excellent communications skills in Spanish /English