• Posted date 04 December 2022
• LocationDublin
• Job type Permanent

• SalaryNegotiable
• Discipline Life Sciences
• ReferenceJO-2211-505340

QC Development Analyst

Dublin

Pharmaceutical

Permanent

The primary purpose of the Development Analyst is to analyse raw material, in-process and finished product as well as stability samples according to the relevant specifications relating to development products while ensuring the documenting and reporting of same is conducted in accordance with good laboratory practices.

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  Working as directed by the Area Supervisor or Manager, in accordance with Company safety policies, cGMP and cGLP.
• Receiving and logging samples into the Laboratory.
• Analysing raw material, in-process, finished product and stability samples associated with development products according to specifications.
• Performing analytical method validations/verifications/method transfers and investigational testing.
• Recording results in a timely and accurate fashion.
• Ensuring the Right First Time KPI with respect to Analyst’s documentation are achieved.
• Reviewing co-workers/analyst documentation (i.e. Buddy System)
• Ensuring that all Quality Systems within the department are adhered to on a daily basis.
• Ensuring correct labelling of laboratory reagents and samples.
• Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
• Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance.
• Training other laboratory staff as requested and appropriate.

The Person

The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.

• At least 12 months experience working within a cGMP environment (HPRA and FDA approved).
• A minimum of a BSc (hons) in a science related discipline.
• Extensive analytical testing experience with HPLC, GC, dissolution is required (Desired Level: Subject Matter Expert)
• Ability to critically review analytical data. Possessing excellent attention to detail is a must.
• Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
• The ability to work well with all key contacts both internal and external to the organisation.

For a confidential discussion, reach out to aisling.murray@cpl.ie