Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis; and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

QC Raw Materials and Compendial Scientist Reporting to the QC Raw Materials and Compendial Senior Scientist the successful candidate will be responsible for carrying out tasks and supporting projects related to the QC testing and release of raw materials ensuring that the highest standards of GMP, GLP and Regulatory are strictly adhered to.

The Role:

• Ensure the tasks associated with the startup and routine operations of a QC Raw Materials and Compendial laboratory are carried out in a safe manner.

• Support QC Raw Materials and Compendial laboratory set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs. • Support facility qualification, process validation, etc.

• Develop and maintain quality systems within the QC Raw Materials and Compendial laboratory to ensure compliance to GMP / GLP.

• Development of training material for the QC Raw Materials and Compendial laboratory personnel.

• Support and lead QC test method validation and development of routine testing strategies when required.

• Perform additional duties at the request of the direct manager.

• Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.

• Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.

• Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.

• Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations.

• Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.

• Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.

• Participate in relevant internal and external QC related audits. • Ability to work in a team environment and independently as required.

• Train other QC analysts and manufacturing personnel in laboratory methods and procedures when required.

• Perform job specific tasks in compliance with applicable Regulations, International Standards, and the site Policies and Standard Operating Procedures.

• Thorough understanding of current Good Manufacturing Practices

• Perform all duties in accordance with GMP requirements, SOPs and controlled documents

• Flexibility to take on additional tasks and responsibilities at the discretion of the QC Raw Materials and Compendial Senior Scientist

• Will act as a role model for the QC function and also the wider organisation in adherence to the sites corporate core values and culture.

Where you’ve come from:

• Bachelor’s degree in Science, Quality or related discipline.

• Experience in a large-scale Biopharmaceutical/pharmaceutical facility.

• Experience with facility start-up projects (brown field or green field) is desirable.

• Experience in Training of personnel.

• Previous experience in a Quality Control/GMP environment is required.

• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.

• Familiarity with Pharmacopeia testing methods and requirements.

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable.

• Experience with regulatory/customer audits is desirable.

• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.

Who you are:

• Excellent communication, interpersonal and presentation skills.

• Ability to think critically and demonstrate troubleshooting and problem solving skills.

• Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.

• Collaborative and inclusive approach to work and your colleagues.

• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.

• Engage cross functionally in conjunction with a site-based team.

• Autonomous and a self-starter who will use their initiative to drive actions forward.

• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations