Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.
Essential Functions :
1. Support Internal Compliance Function as required (QSR / ISO training, internal and external audits, trends analysis, etc. )
2. Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
3.Support Operation in the generation of generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-
conformance and in the development and execution of strategic and tactical plans to run base business.
4. Lead and / or support Plant Initiatives and.or special projects.
5. Supports initiates investigations of non conformance (such as but not limited to NCR, CAPA, Audits Observations), and initiates and maintains interplant communications of quality ossues.
6. Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process.
product- related problems. Promotes and applies Process Excellence Methodology to improve products.processes. systems. Supports validations as required.
7. Performs other tasks as assigned by the Quality Manager and / or QA Plant Director.
8. Develop, write and approve as required policies, procedures, test methods, specifications.
9. Support the Plant Sterilization processes.
10. Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes.
Facilitate the design transfer process between corporate and plant environments.
11. Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR's and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas.
12. Approve and support the control and disposition of non-conformance material as per applicable procedures.
13. Perform product impact assessments and the determination of non-conformance scope (i.e. bounding).
14. Attend and support Operation meetings.
15. Support manufacturing in the day-to-day troubleshooting situations and actively participates on Integrated Production Team's (IPT).
16. Acts as designated Quality Manager when needed.
17. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
Education and Experience :
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.