Job Ref: 215761957

Date: 2022-02-08 12:29:43

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Post Title : QC Analytical Chemist – Raw materials

Division : Quality Control

Location : Milton Keynes

Contract : 1 – year contract with view to extend

Hours : 37.5 per week

Reports to : QC Manager

Job title : QC Analytical Chemist – Raw materials

Contract : Interim, 12 month contract

IR35 : Inside IR35

Rate : Up to £250 per day, based on experience

Location : Milton Keynes

Start : Flexible but ideally as soon as possible

PLEASE NOTE, NO SPONSOR IS OFFERED

Company Division Overview

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Purpose of Role

An exciting opportunity has opened within the Quality Control team in our UK’s, Animal Health business to facilitate projects for Raw Materials testing and release.

For anyone looking to use existing and develop new skills, this is a great opportunity. This brings an opportunity to interact with our global teams to implement improvements in existing test methods for raw materials and establish harmonised tools within QC labs in the UK. It will allow you to expand your knowledge within the global project framework.

Key Accountabilities and Duties

Implement 100% Identification for raw materials procured, tested and released on site.

Create and implement reduced testing plan for the raw materials tested and released on site.

Perform gap assessments for test plans currently used for raw material testing and release and address gaps to ensure compliance with GMP requirements.

Establish and revise SOP’s and material specifications in accordance with current compendial chapters / monographs and updates.

Perform testing of raw materials and packaging material in accordance with GMP, product licence and compendial chapters / monographs, using conventional analytical techniques e.g. FTIR, UV, TOC analyser, Titrations, wet chemistry techniques.

Facilitate equipment qualification for raw material testing and release.

Train operators in new methods and equipment use, to facilitate raw material testing and release.

Report and investigate OOS / OOT results, investigate root cause and rectify problem. Raise CAPA actions.

Raise change controls and be the change manager for implementing changes to test methods / plans and equipment.

Ensure data integrity is maintained throughout.

Perform and lead cross functional investigations.

Other responsibilities

Self motivated and well organized

Excellent communication skills

Has an acute understanding of GMP processes and requirements and have Quality experience

Has sound understanding of analytical techniques such as Raman, FTIR, UV, TOC analyser, Titrations, wet chemistry techniques.

Has experience of working with raw material testing and set up of raw material programs and experience with Ph. Eur and USP.

Has SOP writing / review experience for the ability to change existing, create new, and review SOPs to align with the new qualified methods / equipments.

Has a good understanding of Analytical Standards, Laboratory Method calculations, specification limits.

Has sound understanding of equipment qualification requirements.

The above list of duties is not exhaustive and is subject to change. The post holder may be required to undertake other duties within the scope and grading of the post.

Person Specification

Spectrophotometric Analyses (FTIR, UV / VIS), TOC

Wet Chemistry techniques including titrations, digestions, full metal analysis

GMP Compliance

Experience

Minimum 5 years background in Pharmaceutical QA / Analytical Lead

Raw Materials testing including pharmacopoeia

Laboratory investigations

Validation and method development

Previous roles include interaction with other operations and technical roles

Skills & Abilities

MS Word and Excel

Protocol and Report writing

Ability to troubleshoot to resolve

Basic Statistical understanding such as Minitab Statistical software

Personal Attributes

Able to communicate at all levels and across all functions

Ability to communicate concise technical information with clarity

Ideal candidate should be self-motivated, be able to work under pressure to deliver success within set timelines and hold a positive mindset

Able to assist in Fact finding discussions

Flexible approach to changing priorities

Attention to detail

Qualifications

Degree in Applied Chemistry

Other Requirements

Fluent in English Speaking / writing

Full Drivers Licence

Cross functional work experience

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