Analytical Development Supervisor

22/04/21 Dublin Neg

Permanent full-time

My client, a rapidly expanding innovative pharmaceutical company, is seeking an Analytical Development Supervisor to join their team based just north of Dublin City Centre.

This is an excellent opportunity to join a company that is passionate about tackling complex pharmaceutical development projects and finding solutions for patients with unmet medical needs.

The successful candidate will report to the Technical Director and be responsible for leading all analytical method development / analytical method validation activities.

Responsibilities:

• Analytical method R&D and also validation for new and existing products.
• Coordinating new product introductions and method transfers into the laboratory.
• Prepare, review and approve method development, method validation and equipment protocols, as required.
• Conduct and report test method development, validation and technical transfer ensuring that scheduled work is completed accurately and within agreed timelines.
• Assist in trouble-shooting issues with existing methods.
• Provide data for regulatory submissions.
• Write and review relevant sections of regulatory submissions.
• Liaise with other departments in relation to testing requirements, as necessary.
• Ensure that all work is conducted, and all relevant documentation is maintained, to an acceptable GLP standard.
• Ensure effective and timely closure on all technical issues, OOS, OOT and Deviation Investigations/Reports, as applicable.
• Prepare, review and approve SOPs, as required.
• Provide technical support and problem solving for equipment and other methods, including pharmacopoeial, as required.
• Ensure that work is carried out safely and in line with the company Health and Safety statement and relevant SOPs.
• Ensure good housekeeping practices within the laboratory.
• Staff mentoring and training.

Requirements:

• Degree in Pharmacy or Chemistry or similar qualification.
• At least 2 years relevant analytical method development/method validation experience in a pharmaceutical laboratory.
• cGMP/GLP/GDP.
• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
• Excellent critical thinking and problem-solving abilities.
• Excellent Project Management Skills. 
• Strong interpersonal and communication skills. 
• Experience in leading, managing and motivating teams.
• Excels under pressure.
• Empower 3 LC Software Experience desirable but not essential.

At Quorum Search Partners we respect your privacy. Your CV is sent to us in complete confidence and will never be forwarded to a third party without your consent.

INDHP

 

Please apply by sending your CV to Joanne Walsh at joanne@qsp.ie or call for more information.

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