QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA
Responsibilities:
- Provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicable
- Change Controls assessor
- Change Control development & presenter
- CAPA proposal and implementation plan development & presenter
- URS’s, RD’s, DS’s reviewer / approver /owner
- Maintenance Master Package (MMP) reviewer / approver / owner
- Test Runs / Protocols (PTCs) reviewer / approver / execution and/or support (may be author in very specific cases)
- FAT's / SAT's author / reviewer / approver / execution and/or support
- Functional tests author / reviewer / approver / execution and/or support
- IOQ / PQ reviewer / execution and/or support
- P&ID and official drawings reviewer / approver / owner
- SOP & Forms: author / reviewer / approver /owner (equipment systems), reviewer (process)
- Job Plans development, reviewer and maintenance
- Spare parts reviewer, approver and maintenance
- Provide troubleshooting support as required by operations / engineering
- Analyze downtime incidents as per Equipment Failure, prepare recommendations, create action plans and execute to eliminate recurrence
- Participate actively in the support of High Skills equipment breakdowns, which could impact the operation with an extensive downtime
- Perform or review equipment / system Root Cause Analysis investigations
- Participate in risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs)
- Generate or support the generation of One-point-lessons for systems / equipment
- Identify, evaluate, develop / design, plan and implement solutions for equipment / process improvement opportunities
- Development, execution and implementation of corrective and preventive actions (CAPAs)
- Assist in generation of training materials and in providing training on scientific, technical operations aspects of the equipment / systems
Qualifications:
- Bachelor Degree in Engineering
- Five (5) years of Previous experience in Engineering
- Knowledge in systems:
a. MAXIMO – Owner (RSO)
b. CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier
c. QMTS – Deviation Initiator and Owner, Change Control Owner
d. GDMS – Owner - Availability for 1st shift (8AM a 5PM Monday to Friday)
Top Skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
