Senior QC Analyst - Tipperary

Company: Confidential
Your Application: You have not applied yet
Location: Tipperary, Irlanda
JOB DESCRIPTION

?This is a great opportunity for an experienced QC Analyst to take on a Senior role at a growing site as they move towards full commercial production.
This is an initial 12 month contract role working on a day shift.
Previous experience working on Inhalation products is highly desired.
Responsibilities for the role are as follows;
Technical Laboratory SME with experience representing company in regulatory audits (i.e. front room experience responding to FDA / HPRA audit queries)

Detailed understanding of Inhalation product testing requirements.

Ability to translate knowledge on Inhalation product testing to the laboratory testing program.

Supports Laboratory Set-up activities

Prepares Laboratory procedures, specifications, protocols & reports as required

Performs Laboratory testing and investigations per SOP, applicable regulations and cGMP

Performs peer review of documentation as required

Performs Analytical method verification, validation and technical transfer as required


Supports Laboratory/Site EHS governance

Performs management of Laboratory consumables ordering and tracking

Assists in Equipment Qualification activities, ordering and tracking as required

Supports preparation for regulatory audits/visits and ongoing audit readiness

Supports development of QC Testing processes

Liaises with CROs and audits where appropriate

Report problems with quality, processes and materials to the HOD.
About You:

Degree in Analytical Chemistry or similar

3-5 years of experience in a cGMP QC testing lab

Inhalation experience is highly desired
For more on the role call Nigel on 087 3618142 or send your CV for consideration.



JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: No experience



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