Job Description
A highly skilled QC Chemist is sought for a 12-24 month contracting position in our Waterford-based pharmaceutical client site. The successful candidate will have expertise in analytical chemistry.
Key Responsibilities:
* Provide analytical chemistry services and support to the Site.
* Maintain effective interactions with other departments, including Quality Assurance, Production, Engineering, and Planners, on matters related to raw materials, intermediates, and finished batch releases.
* Develop, update, and issue chemical methods, specifications, and Standard Operating Procedures (SOPs) in compliance with pharmacopoeial and regulatory requirements.
* Assist in training analysts in areas of expertise, new methods, SOPs, and updates.
* Trend results, record on Certificates of Analysis (COAs) where required, and complete Out-of-Specification (OOS) investigations in a timely manner.
* Update the QC Team Leader on potential problems and suggest improvements through regular communication.
* E nsure all quality documentation and records are complete and up-to-date.
* E nsure the QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
* E nsure relevant procedures are correctly defined and followed.
* E nsure critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where necessary.
* Audit and review chemistry test results daily to ensure compliance with cGLP.
* C heck laboratory notebooks and analytical reports.
* E nsure compliance with current Good Manufacturing Practice (cGMP) at all times.
Requirements:
* Bachelor's degree in Science (Chemistry or Biochemistry preferred).
* Postgraduate studies as appropriate to augment primary degree.
* 2-3 years of experience working in a manufacturing environment preferred.