1503-QC Chemist-Waterford Contractor

QC Chemist

Purpose

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.

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 pharmacopeia’s 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.
• Conduct duties in a safe manner and report all safety issues or concerns.

Qualifications

• 3 years working within a QC department in a Pharmaceutical/GMP facility
• Experience in TOC, conductivity, requalification of equipment, system suitability, calibrations, Empower is essential.
• 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)