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Employer CPL
Job Title QC Chemistry Specialist- US Pharma Start
Description

QC Chemistry Specialist- US Pharma Start up- Westmeath

My client, a clinical- stage pharmaceutical company, are looking for QC Chemistry Specialist to establish and develop the QC laboratory and analytical capability during the start-up phase and into sustained operations.

The Job

Your primary role will be to assure that all raw materials, components, and products manufactured at the company’s site are tested and evaluated in accordance with cGMP’s and pertinent corporate and regulatory requirements.

You will support method transfer and validation, contract laboratory oversight, and provide laboratory and analytical support for relevant qualification, validation and verification studies (e.g. clean utility, process equipment cleaning) at the site.

You will also support operational readiness activities in preparation of product launches.

You will be involved in setting up and qualification of Raw Material Vendors, Performing Raw Material and Component release testing and developing all required QC records and documents.

You will be responsible for performance of intermediate bulk product testing and all finished product release and investigative testing and compiling finished product release records and qualification of all required laboratory instrumentation and setting up of instrument calibration and maintenance schedules

You will develop stability protocols and program and execute stability testing in accordance with approved stability protocols

You will develop, co-ordinate and execute all required method transfers and validation for all API, Excipient, and finished product assays and write reports

You will be involved in project co-ordination with Operations and Engineering relating to all Qualification and Validation activities, including clean utility (e.g. WFI) qualification and process equipment (e.g. tanks , filling lines) cleaning validation studies

You will develop site specific QC SOP’s and analytical instrument procedures

You will be involved in investigation of Out of Specification and Out Of Trend events and writing investigation reports as well as investigation and reporting of stability deviations.

Your role will involve development and execution of sampling protocols and the reference and retention sample programs for raw materials, components, in-process and finished products and stability (as applicable)

The Company

As QC Chemistry Specialist, you will get to experience working in a start- up environment on blockbuster products, for a company whose core values are Respect, Integrity and Responsibility.

The Fit

Technical skills required for this role:

Degree in Science or related area (Chemistry / Analytical Chemistry preferred)

Direct experience of (including leadership) of analytical method technical transfer

Operational experience of QC laboratory in a dynamic manufacturing environment.

Understanding of Quality Management Systems and cGMP for US and EU

Excellent process understanding of the various stages of sterile manufacturing through to inspection and packaging

3 - 5 years’ experience in HPLC / GC / UV-Vis Spectrophotometry / Pharmacopoeial Testing within Pharmaceutical industry

Instrument Qualification, Cleaning Validation and Analytical Method Transfer/Validation Experience

Soft skills required for this role:

Excellent communication skills (interpersonal, presentation & writing)

Highly motivated and self-resilient

Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment

Energetic in the pursuit of improved processes and ultimately improved performance

Focussed on own professional development and upskilling

The Offer

The salary is very competitive and benefits would include healthcare, pension, share options and much more.

To apply:

Are you the one? Apply now by clicking the Apply button, or email me for more information at Amina.Tutunova@cpl.ie Not ready to apply, or have some questions first? Call me, Amina Tutunova, on (01) 6146161 to discuss in confidence!

This job originally appeared on RecruitIreland.com
Location Westmeath
Date Added 71 days ago
Apply Link
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