Validation Officer

To ensure that all new and existing Nelsons products are analysed with appropriate, scientifically valid test methods and equipment in order to assist the Research & Development (R&D) and Quality Control (QC) teams with regulatory compliance

 

 Key Responsibilities

▪ Hands on role, developing scientifically valid analytical test methods for new finished products, herbal tinctures, and raw materials, adhering to key timelines in the new product development (NPD) process.

▪ 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

▪ Visiting and auditing of third party laboratories to ensure their capabilities

▪ 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 outsourced testing to see if it can be brought in-house to save costs

▪ Regular review of equipment and calibration required to achieve scientifically valid analytical test methods

▪ Training and coaching Technicians on new, approved methods

▪ Approve analysis performed by Technicians

▪ Ensure all laboratory tasks performed are in keeping with the principles of Good Laboratory Practice

▪ Ensure all quality data is accurately recorded, approved, provided to the QA team for review in a timely manner and is filed appropriately

▪ Be an active part of the laboratory management team, support R&D and Quality Control when required e.g. conduct out of specification investigations

 

Person Specification

Qualifications

Degree qualifications or above in a Science subject

 

Skills & Experience

Essential

▪ Minimum of 3 years experience in an analytical laboratory role

▪ Experienced in performing analytical test method development and validation

▪ Good knowledge of chemical, physical and microbiological analytical techniques for pharmaceutical oral liquids, tablets, capsules, creams, gels etc

▪ Good knowledge of HPLC and GC techniques

▪ Experience of testing and establishing specifications for raw materials and components

▪ A good appreciation of Good Laboratory Practice - its implementation and compliance

▪ Strong report writing skills

▪ Experience in conducting out of specification (oos) investigations

▪ Good attention to detail

▪ Practical and organised approach

Desirable

▪ Experience in identification and testing of plant material and plant tinctures according to various pharmacopeia

▪ Experience of TLC techniques

▪ Experience of pharmaceutical production processes for tablets, liquids and creams

▪ A good appreciation of microbiological techniques and application in a GMP environment

▪ Knowledge of MRP systems such as Sage or SAP