Validation Officer East MidlandsPermanent Full Time Salary attractive dependant upon experienceHave you worked as a Validation Officer within the Pharmaceutical Industry?Do you have manufacturing experience?Role:...
Laboratory Validation Officer (Pharmaceuticals)
£32,000 - £36,000 + Bonus + Benefits
Do you have experience of method development and method validation using HPLC & GC?
Would you like to work for a market leading Pharmaceutical Company in London?
Reporting to the Head of R&D and Product Development, the Laboratory Validation Officer will play a key role in ensuring analytical methods are developed and validated, and documents submitted according to regulatory and ICH requirements.
The role is looking for an an experienced Analytical Chemist or QC Analyst who will work across Product Development as well as Commercial Manufacturing, to ensure product quality is maintained throughout the development life-cycle.
This is a great opportunity to work in a project based role, for a successful company with a strong portfolio of on market products, as well as a promising development pipeline.Specific Responsibilities will include;
- Ensure validation of existing chemical, physical and microbiological analytical test methods for all product types
- Validation of new and existing analytical equipment
- Create and maintain analytical test method and equipment validation master plans
- Manage outsourcing of analytical test method validation where appropriate to suitable third party laboratories
- Document user requirement specifications (URS), and IQ/OQ/PQ protocols and reports, for review by Quality Assurance
- Provide validation input and support to regulatory submissions to authorities such as the MHRA, FDA and TGA
- Regular review of all test procedures, specifications and changes to pharmacopeia
- Regular review of equipment and calibration required to achieve scientifically valid analytical test methods
- Training and coaching Technicians on new, approved methods
To be considered for the role it is essential you have strong experience within method development and method validation on HPLC and GC, to GMP / GLP / ICH guidelines. This should be across raw materials, APIs and finished products such as pharmaceutical oral liquids, tablets, capsules, creams, gels etc.You must have a strong background in completing technical laboratory documentation, as well as quality (QA) aspects such as OOS investigations.You will also need excellent communication, team working and organisation skills, with the ability to manage your work in a changing environment to multiple deadlines. Key Words "Method Validation, Method Development, Analytical Chemist, Analytical Chemistry, Analytical Development, HPLC, Quality Control, Validation, QC, GC, Pharmaceutical Analysis, GMP, ICH, GLP, QA, Quality Assurance, London, Berkshire, Surrey" Please apply online, email your CV or call 02030964706 for further information
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.