Job description

It's fun to work in a company where people truly BELIEVE in what they are doing!

We're committed to bringing passion and customer focus to the business.

The ideal candidate will have a strong commitment to quality assurance principles, analytical approach and excellent attention to details. Good interpersonal skills and technical aptitude.

Main purpose of job:

Perform analytical testing in an efficient and effective manner under cGMP guidelines.

Take a lead role in method transfer activities collaborating with other PCI Pharma sites.

Actively participate in new departmental training and adhere to company policy/procedures and pertinent regulatory/company requirements.

Main responsibilities:

• Perform routine testing with a right first time approach with minimal out of specifications and deviations.
• Play an active role in technical transfer activities.
• Assist in preparation and review of technical documentation within the department as required.
• Meet testing schedule deadlines and assist other members of staff as and when required.
• Monitor and maintain laboratory inventory levels as well as prepare various logbooks for analytical and equipment usage.
• Take ownership of incoming and outgoing samples concerning different project work.
• Train other members of staff following company policy and procedures.
• Deputise for departmental management when required, attend meetings and respond to internal queries as required.
• Take ownership of any training implemented by management or by the company.
• Identify, raise, progress any OOS, deviations and Capa’s liaising with management and the QA department.
• Adhere to the Company Health & Safety policy and take initiative to identify any potential risks.
• Ensure all analytical and documented work is carried out under cGMP and GXP guidelines.
• Ensure on-going compliance with customer, regulatory and internal requirements.
• Actively participate in continuous improvement projects to maintain a high standard of testing.

Requirements:

• Formally qualified to Degree level in Chemistry or related field.
• Minimum 3 years’ experience within a GMP regulated pharmaceutical company.
• Formal training in cGMP requirements from Quality Assurance.
• High level knowledge of commonly used wet chemistry techniques and analytical equipment.
• Dissolution / HPLC Theory and maintenance.
• Good working knowledge of cGMP/GXP guidelines.
• Knowledge of ICH guidelines.
• Experience on CDS such as empowe

Job Type: Full-time

Benefits:

• Company pension
• On-site parking
• Wellness program

Schedule:

• Monday to Friday

Supplemental pay types:

• Performance bonus

Ability to commute/relocate:

• Stamullin, CO. Meath: reliably commute or plan to relocate before starting work (required)

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