Analytical Development Data Reviewer - County Waterford.

Job Purpose:

To support Product Development and Clinical Supply.

To review all data associated with developing, transferring or validating analytical test methods as applicable.

Key Responsibilities:

1. To review all data associated with the development, transfer or validation of robust, sound analytical methods.
2. To review test methods, validation protocols and reports as applicable.
3. To prepare submission documentation in support of license applications.
4. To take part in /lead Laboratory Investigations.
5. To attend internal project review meetings as required.
6. To assist in the preparation for customer/ regulatory inspections
7. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
8. To review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product.
9. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
10. To review all data to ensure that it is completed 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.
11. To perform additional team tasks as agreed to support effective running of the Business.
12. To support all other on-going laboratory functions & requirements.

Minimum Qualifications & Experience Required

Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
At least five years' experience working in a related technical environment.

Strong attention to detail.
Strong analytical ability.
Strong quality orientation.
Good time management.
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.
Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
Knowledge of Project management skills
Proficient in the use of HPLC & associated problem solving.
Ideally a working knowledge of Empower laboratory software or similar.
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.