Job Details: Manufacturing Specialist


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Manufacturing Specialist
Job Description

The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:
* Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
* Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
* Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
* Assisting as needed in audit by external agencies in answering questions related to NCs
* Performing other duties as required by Manufacturing Management Basic
 

Requirements

* Ability to communicate and collaborate with technical and management staff

* Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions
* Project Management experience
* Experience interacting with representatives of regulatory agencies
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR
* Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
* 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
* Detailed technical understanding of fill/finish oJob Description

The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs). Specific responsibilities include but are not limited to:
* Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner
* Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
* Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded
* Assisting as needed in audit by external agencies in answering questions related to NCs
* Performing other duties as required by Manufacturing Management Basic
 

Requirements

* Ability to communicate and collaborate with technical and management staff

* Experience with investigations into manufacturing deviations and determination fo product impact potential, root cause, and corrective actions
* Project Management experience
* Experience interacting with representatives of regulatory agencies
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR
* Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
* 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
* Detailed technical understanding of fill/finish o

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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