QC Chemists

Role Purpose:

• Our client based in Co. Waterford is looking for QC Chemists to join their busy biopharmaceutical facility.
• The function of this position is to provide chemistry support and knowledge to the QC team and to other departments.
• This position also includes performing QC testing by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
• The chemistry team is highly flexible and provides cross functional support.
• This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.
• This will be a Monday to Friday role (39 hours). Changes to hours may be a requirement in future including shift hours (nights and weekends). Overtime may be required.

Core Duties and Responsibilities:

• Provide Chemistry support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Chemistry Team and external departments. In particular, close contact maintained with the Microbiology, Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC-Chemistry testing (water sampling, water testing, TOC, conductivity, swabbing, pH and more) as required.
• Compliance with cGMP and Standard Operating Procedures and pharmacopeias at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Chemistry representation at cross functional meetings.
• Providing audit support for tours and presentations as required.
• Supporting projects as required.

Education & Qualifications Required:

• Degree in Science or related area (Chemistry, Chemistry, Biotechnology or Biochemistry preferred)
• Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo
• Understands Key Performance Indicators
• Knowledge of quality management systems (e.g. Veeva/Qualipso)
• Knowledge of lab management systems (e.g. LUNA)
• Be a motivated, ambitious and goal-oriented individual.
• 2-3 years working within a QC department in a Pharmaceutical/GMP facility would be an advantage
• Experience in TOC, conductivity, requalification of equipment, system suitability, calibrations would be an advantage.

Please note, we do not require agency assistance with this role.