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Senior QA Specialist

Employer
i-Pharm Consulting
Location
Dublin, Republic of Ireland
Salary
£335.76 - £344.15 per day
Start date
11 Jul 2019
Closing date
25 Jul 2019

View more

Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Description:

The Specialist QA is a position within the Quality Regional Work Cell in Europe reporting to the Senior Manager, QA (ESQ). The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes. In addition to routine Quality Assurance duties, the QA Specialist may be assigned specific oversight and responsibility for key processes improvements with the Regional Work Cell and the wider External Supply Quality Organisation.
Key Responsibilities
* Manage and own NC records for External Quality
* Manage and own CAPA records for External Quality
* Manage and own Change Control records internal to External Quality
* Manage and drive Quality records to closure independently
* Perform tactical batch disposition activities in support of lot release
* Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR)
* Escalate risks or roadblocks to management
* Drive timely decision making using Amgen decision making principles
* Drive continuous improvements and Amgen first mindset
* Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
* Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation
* Align and support the tools in use to manage Regional Work Cell activities including Visual management, level loading, capacity & capability management
* Create and foster an environment of change and development within the Regional Work Cell and seek to influence beyond.
* Create and foster key relationships to enable timely completion of activities and responsibilities.

Authority
* Own Quality record content
* Works under minimal direction
* Identify opportunities and issues, then determine when escalation is necessary
* Proposes revisions to SOPs in area of responsibility
* Identifies key improvement opportunities and highlights to management

Basic Qualifications:
* Doctorate degree OR
* Master's degree & 2 years of directly related experience OR
* Bachelor's degree & 4 years of directly related experience OR
* Associate's degree & 10 years of directly related experience OR
* High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor's Degree in a Science Field
* cGMP Experience
* Ability to oversee multiple projects simultaneously
* Able to successfully manage workload to timelines
* Ability to negotiate a position after taking feedback from multiple sources
* Demonstrated ability to consistently deliver on-time, and high-quality results
* Ability to operate in a matrixed or team environment
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
* Ability to travel +/- 10% of time to domestic and international Amgen sites

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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