PE Global is currently recruiting for a QC Chemist II for a client site in Cork–
12 month initial contract
This QC Chemist II 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.
QC Chemist II, within the QC Technical Support function.
Specific Job 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 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 the network including Foster City, New Jersey, Edmonton and Oceanside.
Skills & Expertise:
- 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.
- Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations
- Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
- Ability to work independently and as part of a team with internal and external partners, self-motivation and adaptability
Typical Education & Experience
- 5+ years of relevant experience with BA or BSc degree in Chemistry.
- 3+ years of relevant experience with MSc degree in Chemistry.
Behaviours
- Resilient & dynamic profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organised with systematic approach to prioritisation
- Process orientated to achieve the business objective
Interested candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900
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