Kelly Services are recruiting for an experienced Analytical Chemist for a County Waterford based pharmaceutical company. The Analytical Chemist will support Product Development and Clinical Supply. and troubleshoot, develop, transfer or validate of analytical test methods as applicable.
- To troubleshoot, develop, transfer and validate robust, sound analytical methods.
- To draft/ review test methods, validation protocols and reports as applicable.
- To prepare submission documentation in support of license applications.
- To take part in/lead laboratory investigations.
- To liase directly with customers and contract laboratories and attend conference calls as required.
- To attend internal project review meetings as required.
- To assist in the preparation for customer/ regulatory inspections.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- To analyse all raw materials, in process samples and finished products in a timely and efficient manner to ensure quality and efficacy of the product.
- To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
- To perform additional team tasks as agreed to support effective running of the Business.
- To support all other on-going laboratory functions & requirements.
Minimum Qualifications & Experience
- Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
- At least two years' experience working in a related technical environment.
Skills & Competencies
- Strong analytical ability.
- Strong quality orientation.
- Good time management.
- Strong attention to detail.
- Good problem solving abilities.
- Excellent organisational skills.
- Ability to multitask and work under pressure, coping with more than one conflicting task at once.
- Excellent communication skills, both verbal & written.
- Adaptability - ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
- Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
- Ability to work effectively with a team to accomplish organisational goals
- Knowledge of Project management skills
- Proficient in the use of HPLC & associated problem solving.
- Working knowledge of Empower laboratory software.
- Proficient in dissolution testing
- Proficient in the use of electronic document management systems.
- Proficient in Technical report writing
- Strong Safety awareness.
- Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.