- Troubleshoot, develop, transfer and validate robust, sound analytical methods.
- To draft/ review test methods, validation protocols and reports as applicable.
- 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.
- 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.
Health and Safety
- To ensure the requirements of company 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 two 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.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4809118 or email firstname.lastname@example.org