Are you a Senior QA associate with experience in the biotech or pharma industries? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QA Associate - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
This job specification outlines the general responsibilities associated with the role of Sr. Associate QA on the Amgen Dun Laoghaire Manufacturing Site. The Snr QA Associate will be a core member of the site Quality team supporting manufacturing operations and will serve as Quality point of contact for manufacturing.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
Basic Qualifications
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Quality representative in Non Conformance triage using 5 Why or similar methodology
Quality participation in Root Cause Analysis
Review and approval of Non Conformances and CAPAs.
Observation of interventions on aseptic fill line
Perform quality walks of manufacturing area and manage actions
Performs Quality Audits to ensure compliance with cGMPs
Review of electronic and / or paper BR?s
Compile QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses.
Perform status changes and yields on the computer system and assign expiry date to products
Prepare deviation reports for shipments as required
Review and approve Master Batch Records
Write, review and approve Standard Operating Procedures in accordance with Amgen
Policies
Approves Systems validation protocols on behalf of QA.
Prepare the agenda for Site Quality Review Team and submits Failure Investigations for Review/Discussion. Prepare the SQRT minutes.
Prepare Monthly Metrics.
Maintain databases and other informational systems as necessary.
Prepare deviation trend reports bi annually to establish any evident trends.
Train new colleagues
Comply with responsibilities as outlined in site Safety Statement and procedures.
Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
Is a champion for safe working practices and safety initiatives within their functional area.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Requirements:
Minimum Requirements
Hold Third Level Qualification (Degree) in Science related discipline: Chemistry, Biology, Biotechnology
Preferred Requirements
Minimum of 3 years relevant experience in a Pharmaceutical/Biotechnology Quality role.
Possess key competencies as follows:
Planning and Organisation, Problem Solving, Team Work, Flexibility, Coaching and Motivation, Role Model
Good Interpersonal Skills
Knowledge of aseptic manufacturing / experience
Involvement in Root Cause Analysis / Non Conformance /Deviation investigations
Package:
Contract rate of 35 euro per hour
Minimum Contract duration: 6 months
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
Amgen Jobs in Ireland
Are you a Senior QA associate with experience in the biotech or pharma industries? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QA Associate - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
This job specification outlines the general responsibilities associated with the role of Sr. Associate QA on the Amgen Dun Laoghaire Manufacturing Site. The Snr QA Associate will be a core member of the site Quality team supporting manufacturing operations and will serve as Quality point of contact for manufacturing.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
Basic Qualifications
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.
Quality representative in Non Conformance triage using 5 Why or similar methodology
Quality participation in Root Cause Analysis
Review and approval of Non Conformances and CAPAs.
Observation of interventions on aseptic fill line
Perform quality walks of manufacturing area and manage actions
Performs Quality Audits to ensure compliance with cGMPs
Review of electronic and / or paper BR?s
Compile QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses.
Perform status changes and yields on the computer system and assign expiry date to products
Prepare deviation reports for shipments as required
Review and approve Master Batch Records
Write, review and approve Standard Operating Procedures in accordance with Amgen
Policies
Approves Systems validation protocols on behalf of QA.
Prepare the agenda for Site Quality Review Team and submits Failure Investigations for Review/Discussion. Prepare the SQRT minutes.
Prepare Monthly Metrics.
Maintain databases and other informational systems as necessary.
Prepare deviation trend reports bi annually to establish any evident trends.
Train new colleagues
Comply with responsibilities as outlined in site Safety Statement and procedures.
Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans.
Is a champion for safe working practices and safety initiatives within their functional area.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Requirements:
Minimum Requirements
Hold Third Level Qualification (Degree) in Science related discipline: Chemistry, Biology, Biotechnology
Preferred Requirements
Minimum of 3 years relevant experience in a Pharmaceutical/Biotechnology Quality role.
Possess key competencies as follows:
Planning and Organisation, Problem Solving, Team Work, Flexibility, Coaching and Motivation, Role Model
Good Interpersonal Skills
Knowledge of aseptic manufacturing / experience
Involvement in Root Cause Analysis / Non Conformance /Deviation investigations
Package:
Contract rate of 35 euro per hour
Minimum Contract duration: 6 months
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
Amgen Jobs in Ireland
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
