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Quality Assurance Technical Support Specialist A1008

At Independent Solutions

Description

This is a remote position.

⦁ JobTitle: Quality Assurance Technical Support Specialist (Remote) A1008

 

⦁ About Company:

Our client, AMGEN, is a multinational biopharmaceutical company with a site in Dun Laoghaire, which includes a bioprocessing suite and laboratories. Make a difference in the lives of others, working at the forefront of biotechnology with the top minds in the field. 

 

AMGEN provides state-of-the-art working facilities, including Next Generation office areas and on-site GYM. In addition, AMGEN provides flexible working conditions, including flex hours and work from home.

 

⦁ Duration of Job: 12 months

 

⦁ Summary Objective:

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

 

⦁ Job Duties:

• Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)

• Quality review and approval of C & Q documentation

o Review of Risk Assessments, DS, URS & QRAES documents

o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents

o Review of executed validation documents and reports

• Perform all activities in compliance with Amgen safety standards and SOPs

• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.

 

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

 

Requirements

⦁ Experience and Education:

• University degree. Science or Engineering related discipline preferred.

• Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new Fill line / Isolator

• Ability to work independently and remotely with minimum direct supervision.

• Critical thinking skills.

• Strong organisational, communication, coordination, and meeting facilitation skills.

• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

 

 

*** No Visa Process ***

 

 

Benefits
 
Benefits of working with Independent Solutions.
 
  • Benefit from Independent Solutions ethical principles!
  • We look after our team, we know the business, we have been working in the sector >20 years.  We are not a recruitment agency
  • While placed on client sites you will be an integral part of our team, gaining support and  access to the knowledge and experience of our cross functional LifeScience team
  • We offer attractive rates - competitive margins compared to our competitors.
  • Payment on time and in full
  • We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
  • We work for you!

 

Skills

⦁ Experience and Education: • University degree. Science or Engineering related discipline preferred. • Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new Fill line / Isolator • Ability to work independently and remotely with minimum direct supervision. • Critical thinking skills. • Strong organisational, communication, coordination, and meeting facilitation skills. • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. *** No Visa Process ***

Education

• University degree. Science or Engineering related discipline preferred.

Experience

5+ years

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