QC Lead Analyst – Quality Operations Laboratory

PSC Biotech® Corporation; Carlow; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

PSC Biotech Corporation in Ireland is seeking a QC Lead Analyst to join our state-of-the-art Quality Operations laboratory. You will lead analytical testing and support release of key drug products, working within a cGMP framework.

The ideal candidate has 4+ years in a pharmaceutical lab with ELISA/HPLC experience and a strong grasp of GLP/GMP systems, and will drive method transfers, validation, and continuous improvement.

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry or closely related field
• 4+ years of experience in a pharmaceutical laboratory
• Good working knowledge of HPLC systems and software is desirable
• Good working knowledge of ELISA and Softmax Pro software is desirable
• Good knowledge of cGMP, GLP, Quality Management Systems

Responsabilités

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and review
• Perform various analytical techniques including ELISA/HPLC/Compendial Assays in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance
• Work collaboratively to drive a safe and compliant culture.

Connaissances

4+ years pharma lab experience

cGMP/GLP knowledge

Quality systems knowledge

Formation

Bachelor's degree in Analytical Chemistry or related

Outils

HPLC

ELISA

SoftMax Pro

Description du poste

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the 'heartbeat' of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• Join a supportive, growing team in the analysis of Biologics and Vaccines in a state-of-the-art Quality Operations laboratory, manufactures and tests biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site.
• The QC Lead Analyst will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing. The team works a 2-cycle shift pattern.
• Occasional travel may be required for training purposes.
• The ideal candidate will have 4+ year's experience in a pharmaceutical laboratory, ideally with experience in ELISA/HPLC/Compendial Testing and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products.

What you will do:

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and review
• Perform various analytical techniques including but not limited ELISA/HPLC/Compendial Assays in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,
• Work collaboratively to drive a safe and compliant culture.

What skills you will need:

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• 4+ years of experience in a pharmaceutical laboratory
• A good working knowledge of HPLC systems and software is desirable
• A good working knowledge of ELISA and Softmax Pro software is desirable
• A good knowledge of cGMP, GLP, Quality Management Systems