Are you a Senior QC Analyst with extensive HPLC testing experience? Do you have a solid background in Pharmaceuticals or Biotechnology? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QC - Labs - Amgen
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 role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a role model for other lab colleagues. The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
Key Responsibilities
• Plan and perform routine analyses with greater efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Responsible for providing technical guidance.
• Provide reports, data analysis to support risk based decisions
• Ensure flow of communication to stakeholders.
• Applies expertise and critical thinking to independently resolve technical issues.
• Manage existing and/or develop and implement new programs, processes and methodologies that enhance productivity /efficiency.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Audit various complex controlled documents.
• May lead audit teams.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• Leads/represents the department on various teams empowered to make decisions impacting QC.
• Expert in HPLC and other analytical techniques such as Capillary Electrophoresis and SDS-PAGE.
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Manage and contribute to the achievements of department productivity and quality goals.
Requirements
•Hold a third level qualification in Science related discipline.
•Have minimum 8 years experience in a pharmaceutical/healthcare Laboratory or a related technical function.
•Strong technical experience in related analytical techniques.
•Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
Package:
12 month minimum contract
Rate: €25 - 30 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
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Amgen Jobs
QA - QC
Are you a Senior QC Analyst with extensive HPLC testing experience? Do you have a solid background in Pharmaceuticals or Biotechnology? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QC - Labs - Amgen
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 role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, without direct supervision, acting as a role model for other lab colleagues. The role undertakes providing technical expertise with a focus on method transfers, continuous improvement and implementing a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
Key Responsibilities
• Plan and perform routine analyses with greater efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Responsible for providing technical guidance.
• Provide reports, data analysis to support risk based decisions
• Ensure flow of communication to stakeholders.
• Applies expertise and critical thinking to independently resolve technical issues.
• Manage existing and/or develop and implement new programs, processes and methodologies that enhance productivity /efficiency.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Audit various complex controlled documents.
• May lead audit teams.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• Leads/represents the department on various teams empowered to make decisions impacting QC.
• Expert in HPLC and other analytical techniques such as Capillary Electrophoresis and SDS-PAGE.
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
• Manage and contribute to the achievements of department productivity and quality goals.
Requirements
•Hold a third level qualification in Science related discipline.
•Have minimum 8 years experience in a pharmaceutical/healthcare Laboratory or a related technical function.
•Strong technical experience in related analytical techniques.
•Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
Package:
12 month minimum contract
Rate: €25 - 30 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Dublin
Amgen Jobs
QA - QC
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
