Our client, a Multinational Biopharmaceutical company, are currently seeking an experienced and proactive QC Chemist.
This role requires significant expertise/specialisation in analytics for Solid Oral Dosage and Biological Product Portfolios. It is responsible for analytical operations including Analytical Method Transfers, New Product Introductions, process & cleaning optimisations, technical investigations, and quality control testing to support our GMP operations.
Responsibilities:
- Involvement in Analytical Method Validation/Transfers for Solid Oral Dosage & for Biological Products as appropriate.
- Execution of process and cleaning validation studies in support of New Product Introductions.
- Provision of technical support to Operations for investigations and optimisation projects.
- Deliver new technologies and continuous improvement initiatives to meet business requirements.
- Support QC TS investigations/troubleshooting and technical projects within the function.
- Support the procurement and qualification of new equipment for new product technology transfers.
- Demonstrates skills in data analysis (ex: UPLC, HPLC, CE,) and ability to critically evaluate data quality.
- Reviews data and results of testing to ensure compliance with appropriate specifications and protocols.
- Writes and executes protocols and reports.
- Assists in the training of QC staff.
- Writes and revises methods, specifications, and SOPs as needed.
- May develop methods for performing cleaning validations.
- Demonstrates and applies an advanced level of understanding of project goals and methods.
- Executes analysis efficiently, consistently, and with high quality and suggests improvements.
- Acts as a resource for other employees within the department.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Professional Experience & Qualifications:
- 5+ years of relevant experience with BA or BSc degree in Chemistry.
- 3+ years of relevant experience with MSc degree in Chemistry.
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing, and interpersonal skills.
- Proficiency in MS Office applications.
Type:
Full time, 12 Month Contract Site-based, Monday-Friday, normalised office hours
Package:
€30.00 - €35 Per Hour
For a confidential discussion on this or any other current opportunities please contact Mark Farrell
mark@logiskills.ie
IAC-Mar22