Analytical Chemist

PSC Biotech; Tipperary; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

PSC Biotech Ireland in Ballydine is hiring a quality analytical chemist to perform and document testing of raw materials, intermediates, and drug substances using approved methods. You will support investigations, technology transfers, method development, stability programs, and train lab personnel while ensuring cGMP compliance and data integrity.

The role involves reviewing data and batch documentation prior to release and mentoring junior analysts in a fast-paced biotech environment.

Competenze

• GMP compliance and quality systems knowledge.
• Proficiency in analytical techniques, instrumentation, maintenance and troubleshooting.
• Strong understanding of data integrity and ALCOA principles.

Mansioni

• Perform testing of raw materials, intermediates, drug substances, and drug products in line with approved methods and specifications.
• Provide analytical support for quality investigations, technology transfers, method development, stability programs and training of laboratory personnel.
• Accurately document testing activities and maintain laboratory records in electronic systems.
• Support and lead analytical investigations, including OOS and quality notification activities.
• Review and verify analytical data and batch documentation prior to product release.
• Provide analytical support for process changes, technology transfers, product demonstrations, and non-routine testing.
• Identify, troubleshoot, and resolve analytical and laboratory-related issues.
• Lead or contribute to continuous improvement, change management and site initiatives.
• Train, mentor, and support the development of laboratory analysts and apprentices.

Conoscenze

GMP awareness

Analytical techniques

Data integrity/ALCOA

Formazione

BSc in Chemistry

Descrizione del lavoro

Ballydine, Ireland

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 the next 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 though 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

Role Functions

Perform and document testing of raw materials, intermediates, and drugsubstances in compliance with analytical standards and approved protocols.Provide analytical support for quality investigations, technology transfers,method development, stability programs, and training of laboratory personnel.

Principal Accountabilities

• Perform testing of raw materials, intermediates, drugsubstances, and drug products in line with approved methods andspecifications.
  
• Ensure compliance with cGMP, data integrity, safety,environmental, and company requirements.
  
• Accurately document testing activities and maintain laboratoryrecords in electronic systems.
  
• Support and lead analytical investigations, including OOS andquality notification activities.
  
• Review and verify analytical data and batch documentation priorto product release.
  
• Provide analytical support for process changes, technologytransfers, product demonstrations, and non-routine testing.
  
• Identify, troubleshoot, and resolve analytical andlaboratory-related issues.
  
• Lead or contribute to continuous improvement, changemanagement, and site initiatives.
  
• Serve as a technical resource and subject matter expert foranalytical testing and laboratory systems.
  
• Train, mentor, and support the development of laboratoryanalysts and apprentices.
  

Requirements

Technical

• Knowledge of GMP, quality systems, laboratory safety, and siteprocedures related to analytical testing and product release.
  
• Proficiency in analytical techniques, instrumentation,maintenance, and troubleshooting.
  
• Strong understanding of data integrity and ALCOA principles.
  

Business

• Perform analytical testing with accuracy, precision, andcompliance.
  
• Maintain complete and accurate laboratory documentation andrecords.
  
• Communicate technical information clearly and effectively.
  
• Support projects, audits, investigations, and cross-functionalcollaboration.
  
• Deliver training and knowledge transfer to laboratorypersonnel.
  

Leadership

• Demonstrated expertise in analytical chemistry and laboratoryoperations.
  
• Strong technical, problem-solving, communication, andinterpersonal skills.
  
• Ability to lead initiatives, influence outcomes, and workindependently.
  

Educational Requirements

• BSc in Chemistry or a related scientific discipline.