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Sr. ad analyst

Cork
Thermo Fisher Scientific Inc.
Analyst
Posted: 15 June
Offer description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The AD chemist will function as a key member of the Team. You'll be responsible to providing technical support for all phases of drug development. This will include high quality analytical and technical support to internal and external customers, to ensure that analytical infrastructure is in place to support the introduction of new products and support development activities. To promote and maintain laboratory GMP / Safety within the Analytical Development (AD) group such that the AD laboratory is maintained as an inspection ready facility. To actively participate in the improvement of the AD group as a center of excellence.

What will you do?

- Provide analytical support, including method development, validation/qualification and transfer of methods to clients.
- Prepare, review, update analytical methods and specifications as appropriate.
- Prepare QC handover package. Present training sessions to QC as agreed with QC and provide technical support during method familiarisation and validation period.
- Support external audits as appropriate.
- Support innovative idea of new analytical methods as well as improvement and optimisation of current methods.
- Complete analytical data collection, interpretation and characterization of compounds while ensuring accurate documentation of experimental data is adhered to.
- Preparation, review change controls, study protocols, project status report, final reports and other internal documentation relevant to the role.
- Develop/Expand scientific, technical knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training.
- Ensure the delivery of projects in the required timeframe and ensure that the site's technical, quality and safety metrics are all achieved.
- Work with due care and attention, perform all quality, regulatory and safety duties whilst acting always with the Dignity at Work Policy, Code of Business Conduct and Ethics and our values : Integrity, Intensity, Innovation and Involvement.
- Candidate should have hands on experience in handling HPLC, GC and other basic instruments (FTIR, UV spec, Balance, pH etc). Experience in LC-MS, GC-MS and NMR will be added advantage.

Quality Responsibilities

- Perform duties in an accurate manner and behave in accordance with our Quality Management System requirements.
- Participate fully in our site's quality initiatives and ensure all relevant quality standards are adhered to.
- Maintain GMP standards.
- Read relevant Standard Operating Procedures and Global Quality Policies, Management Procedures and Guidelines relevant to your job role.
- Attend training and complete assessments.
- Work in a GMP quality compliance manner.
- Be inspection ready.

Behaviours

- Demonstrate behaviours what we value.
- Good Communication
- Good facilitation and presentation Skills
- Leadership, Influencing and Negotiating Skills.
- Positive, can-do approach and passion.

Ability to coach, empower, train and mentor others.

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