Job Details: Quality Assurance Manager


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.
Quality Assurance Manager


Are you an Quality Assurance Specialist with experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Quality Assurance Manager - Waterford



Employer

Our client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland’s top 10 best large workplaces by Great Place to Work Ireland.



Job Description



The QA Manager has a primary role in assuring that products manufactured at the Waterford site are done so in accordance with cGMPs and pertinent corporate and regulatory requirements, in addition to ensuring support for local and global batch release.


Job Requirements

Provide quality expertise and oversight of cGMP activities across the site.

Ensure operations are in compliance with cGMP.

Manage QA team through QA team leaders to provide quality and compliance support for the site.

Ensure Qualified Person support for site and global batch release.

Manage preparation and support for regulatory and external inspections.

Ensure effective management and support for internal auditing, customer complaints and periodic product reviews.

Support departments on matters related to investigations and finished batch releases.  In particular, close contact maintained with the QC, Manufacturing, Process Engineering and Supply Chain.



 
Requirements:



Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)

Post-graduate studies as appropriate  to augment primary degree

Qualified Person status

5 – 7 years’ experience working in the pharmaceutical sector including sterile manufacturing.

3 - 5 years’ experience in management of QA

Project Management Experience

Hosting of Regulatory and Corporate Inspections

Operational experience of quality systems in a dynamic manufacturing environment.

Ability to lead/provide input into technical investigations.

Technical knowledge of sterile manufacturing and pharmaceutical plants

Understanding of Quality Management Systems and cGMP for US and EU.

Able to manage projects to plan/budget.

Effective facilitator with strong leadership skills.

Good communication skills at organisation, team and individual levels.

 

Personal Characteristics

Natural influencer and works well as part of a multi-functional team.

Highly motivated and self-resilient.

Adaptable and flexible as well as a pragmatically minded problem solver.

Energetic in the pursuit of improved processes and ultimately improved performance.

Focussed on development of direct reports.




Package:

€70-80K p.a.

Generous benefits package



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Biotech / Pharma / Medical Device Jobs in Ireland

Jobs in Waterford

QA - QC

Are you an Quality Assurance Specialist with experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Quality Assurance Manager - Waterford



Employer

Our client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland’s top 10 best large workplaces by Great Place to Work Ireland.



Job Description



The QA Manager has a primary role in assuring that products manufactured at the Waterford site are done so in accordance with cGMPs and pertinent corporate and regulatory requirements, in addition to ensuring support for local and global batch release.


Job Requirements

Provide quality expertise and oversight of cGMP activities across the site.

Ensure operations are in compliance with cGMP.

Manage QA team through QA team leaders to provide quality and compliance support for the site.

Ensure Qualified Person support for site and global batch release.

Manage preparation and support for regulatory and external inspections.

Ensure effective management and support for internal auditing, customer complaints and periodic product reviews.

Support departments on matters related to investigations and finished batch releases.  In particular, close contact maintained with the QC, Manufacturing, Process Engineering and Supply Chain.



 
Requirements:



Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)

Post-graduate studies as appropriate  to augment primary degree

Qualified Person status

5 – 7 years’ experience working in the pharmaceutical sector including sterile manufacturing.

3 - 5 years’ experience in management of QA

Project Management Experience

Hosting of Regulatory and Corporate Inspections

Operational experience of quality systems in a dynamic manufacturing environment.

Ability to lead/provide input into technical investigations.

Technical knowledge of sterile manufacturing and pharmaceutical plants

Understanding of Quality Management Systems and cGMP for US and EU.

Able to manage projects to plan/budget.

Effective facilitator with strong leadership skills.

Good communication skills at organisation, team and individual levels.

 

Personal Characteristics

Natural influencer and works well as part of a multi-functional team.

Highly motivated and self-resilient.

Adaptable and flexible as well as a pragmatically minded problem solver.

Energetic in the pursuit of improved processes and ultimately improved performance.

Focussed on development of direct reports.




Package:

€70-80K p.a.

Generous benefits package



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Biotech / Pharma / Medical Device Jobs in Ireland

Jobs in Waterford

QA - QC

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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