Quality Control Chemist

Summary:
Our client is a bio pharmaceutical company based in East Cork looking for a QC Chemist role who will be 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 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 to appropriate specifications and protocols.
• Writes and executes protocols and reports.
• Assists in the training of QC staff.
• Writes and revises methods, specifications, and SOP’s as needed.
• May develop methods for performing cleaning validations.
• Demonstrates and applies an advanced level of understanding of project goals and methods
• Knowledge of current Good Manufacturing Practices
• Excellent communication skills (both verbal and technical) and strong interpersonal skills
• 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.
• Interfaces with key cross functional stakeholders locally, CTLs and across our client’s international sites.

Qualifications & Experience:

• 5+ years of relevant experience with BA or BSc degree in Chemistry.
• 3+ years of relevant experience with MSc degree in Chemistry.
• Experience in test methods for Solid Oral Dosage products.
• Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
• Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
• Hands-on experience with equipment qualification and analytical techniques such as UPLC/HPLC, Water content analysis etc.
• Knowledge of software such as Empower and LIMS.
• Ability to engage and manage multiple stakeholders to achieve the objective.