Fantastic opportunity for an Analytical Development Chemist to join a large pharma company based in Waterford.
- 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.
- To ensure the requirements of the companies Safety Statement are implemented.
- To continuously promote a positive safety culture by leading by example.
- To implement safety requirements as per site documentation including SOP's, Safety Statement and COP's.
- To report any defects/hazards
- Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
- At least three years' experience working in a related technical environment.
- 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.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.