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Prin Quality Engineer

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Company: Genzyme

Location: Framingham, MA

Date Posted: August 22, 2014

Source: Genzyme

Prin Quality Engineer-00471212-38304JC


Description

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of ...

Prin Quality Engineer-00471212-38304JC


Description

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

Position Overview/Summary

As a Principal QualityAssurance Engineer (Technical Support) partner with manufacturing and support teams(e.g. MTS, IT/ Lean, Automation, Facilities) to:

(1) ensure indirect manufacturing activities such as major/ critical deviations, CAPA, tasks, change control, MDI and Lean events are progressed in a compliant and timely manner to meet site targets.

(2) function as the conduit between the Quality Systems team and the value stream to identify and implement meaningful corrective actions arising from agency inspections and internal audits.

Co-ordination:

Develop the technical (process) and quality systems expertise across the value stream.

Engage with manufacturing specialists and designated support team members to ensure compliance and business targets are met for all compliance metrics.

Change Control:

Manage the change control process within the value stream

Schedule and co-ordinate CCR review meeting

Develop and report CCR metrics which drive results for the value stream

Deviations:

Partner with manufacturing and technical support team members to resolve major and critical deviations within agreed timelines, and verify CAPA effectiveness.

Partner with manufacturing and support teams to close of CAPA and tasks within allotted timelines

Generate metrics at the required frequency which drive accountability and delivery of targets

Lean Initiatives/ Continuous Improvement :

Engage with the Lean team to support continuous improvement of our quality and manufacturing systems using Lean tools and implementation of actions arising from Lean and other continuous improvement events

Support Lean events constructively challenging the current state

Quality Systems :

Interface with the Quality Systems team members and the value stream to ensure effective identification and implementation of corrective actions coming from agency inspection and internal audits.



Qualifications

Basic Qualifications

· Bachelor's Degree and 9 years of experience in Quality/Regulatory in a GMP environment

OR

· Master's Degree and 7 years of experience in Quality/Regulatory in a GMP environment

· Knowledge in external agency regulations (FDA, EMA, etc.)

#LI-GZ

~BSP

Preferred Qualificaitons

· Ability to work independently

· Experience determining trends and metrics in Trackwise or equivalent system

· Experience in Quality Assurance

· Experience participating in external agency inspections

· Knowledge of regulatory enforcement trends

· Experience with project management

· Partner with the Quality Systems Organization to drive consistency across the value streams

Experience with Trackwise or equivalent system

· Proficient in Microsoft Office

· Ability to learn technical knowledge (pertinent to the areas of oversight) quickly.

Strong written and verbal communication skills



Job : Quality
Primary Location : United States-Massachusetts-Framingham


Job Posting : Aug 21, 2014, 8:36:28 AM

Shift : Day Job
Job Type : Regular
Employee Status : Regular








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