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Senior Analytical Development Reviewer
Job in
Wellingborough, Northamptonshire, NN8, England, UK
Listed on 2026-09-11
Listing for:
ARx Recruitment Services
Full Time
position Listed on 2026-09-11
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
ROLE, (Includes)
* Review and Approve Analytical Method Development Protocols and Reports
* Review Analytical Method Validation, Verification and Method Transfer Documentation
* Review Raw Analytical Data, Calculations, Chromatograms and Technical Reports for Accuracy and Compliance.
* Ensure Analytical Methods Comply with ICH Guidelines and Pharmacopeial Requirements
* Review Forced Degradation Studies and Stability-Indicating Methods
* Review Dissolution Method Development and Validation Studies
* Support Analytical Investigations, Including OOS, OOT, Deviations and CAPA’s
* Review Analytical Specifications, SOP’s and Technical Documentation
* Support Regulatory Submissions and Responses to MHRA, FDA and Customer Queries
* Ensure Compliance with GMP, ALCOA+ Data Integrity Principles and Company Procedures
* Provide Scientific Guidance to Analytical Development Scientists
* Support Technology Transfer Activities into the Quality Control Laboratories
* Participate in Internal Audits, Customer Audits and Regulatory Inspections
REQUIRED
* MSc or MPharm in Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Analysis or Related Scientific Discipline
* Minimum 5 Years' Experience in Pharmaceutical Analytical Development
* Extensive Involvement in MHRA/FDA Regulated Pharmaceutical Manufacturing Environment
* Hands-On Experience Reviewing Analytical Method Development and Validation Documentation
* Strong HPLC/Chromatography Background and
Experience of a Wide Range of Analytical Instruments/Apparatus and Techniques/Procedures
* Experience Supporting Regulatory Submissions and Inspections
* Foundation of Supporting Analytical Method Development and Validation
* Strong Understanding of ICH Guidelines and Regulatory Expectations
* Hands-On Experience investigating OOS, OOT, Deviations and CAPA’s
* Solid Understanding of Technology Transfer and Lifecycle Management Activities
* Experience Reviewing Stability Studies
* Contract Manufacturing
Experience of Solid Oral Dosage Forms, (Desirable)
Position Requirements
10+ Years
work experience Additional Information / Benefits
Shift Working Rates
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